The FDA has provided clearance for a medical device called Osteoboost, a vibrating belt that improves bone density in patients with osteopenia. The device, which was developed by California-based startup Bone Health Technologies and in part with NASA, is the first medical device of its kind to get regulatory approval as a treatment option for postmenopausal women.

One in two older women who have experienced menopause gets osteoporosis (the disease that comes after prolonged and untreated osteopenia), which is characterized by porous bones that can easily fracture. The Osteoboost belt is designed to prevent bone density from reaching that stage through early intervention. It works by mechanically stimulating the strength of the bones in the hips and spine of a wearer and prevents the further progression of bone density disintegration. The blueprint for the technology comes from NASA research that was investigating ways to prevent bone density from weakening in astronauts that work in mostly zero gravity environments where deterioration becomes a concern.

The belt should be worn for 30 minutes every day or at least five times a week for it to fully take effect. It delivers a gentle vibration that makes it easy to be worn pretty much anywhere or at any time, such as during dog walks or while washing dishes. During clinical trials, CT scans showed that following the integration of the belt into a patient’s care plan, bone density visually improved over time. In a study backed by the NIH, women aged 50 to 60 lost 3.4 percent of their bone density by the end of 12 months without any intervention, while patients who wore the belt lost only 0.5 percent of their bone strength.

Current standards of care for preventing osteoporosis during the osteopenia stage are mostly lifestyle suggestions that can be hard to adhere to, such as a well-balanced and calcium-rich diet, frequent weight-bearing exercises and reducing the risk of falls. “Although lifestyle interventions such as exercise and diet are beneficial to bone, the effect is small. The Osteoboost shows promise in slowing the loss of bone density and strength and may fill the treatment gap,” Laura Bilek, a researcher who has studied the belt’s effectiveness said.

Osteoboost is still not yet available for sale, but you can sign up to get notified when the device is released. A company representative said they will begin shipping later this year and will accept pre-orders in the next few months. While the price is also still not disclosed, the representative told Engadget that the belt will be “affordable and accessible to the millions of patients who need it.” To get the device, you will need a prescription from your doctor — so pricing may vary depending on insurers and co-pays. Bone Health Technology said it is currently in talks with insurers regarding coverage for the medical device. While the price projection could have drastically changed, three years ago the CEO Laura Yecies told NS Medical Devices she believed the device could debut for about $800.

Achieving your fitness goals doesn’t have to be expensive or complicated. Keeping tabs on your daily movement can make you conscious of your activity level and motivate you to stay on top of your gym sessions, or at least hit your steps. That rings especially true if you spend most of your day sitting at a desk like I do. Having a device handy that can keep you accountable can be a game changer. While many smartwatches on the market are decked out with fitness tools, the average affordable tracker might offer just enough to help kickstart your health journey.

You might be surprised by how much a $100 (or less) wearable can do. They go well beyond just counting steps, providing in-depth reports on how you're sleeping at night or giving you a breakdown of your heart rate variability during a workout. But given their price, there are tradeoffs: don’t expect a plethora of features or third-party app integrations. To help you decide which cheap fitness tracker to get, I tested a few of the latest devices that are available for $100 or less to find out which are worth your money.

What to look for in a cheap fitness tracker

Even the most basic tracker should have at least three features: a program to track workouts or movement of some sort, the option to monitor and collect sleep data and the ability to measure health metrics like heart rate and blood oxygen levels (though, the readings might not be super accurate).

Fitness features

A cheap workout tracker can be great for someone looking to keep tabs on small, achievable goals like 10,000 steps before sundown or 30 minutes of a HIIT workout to get your heart rate peaking. An experienced long-distance runner looking to train for a triathlon might opt for a more expensive device that can measure cadence or ground contact time, and can track more customizable workouts or give deeper insights into performance data.

At the very least, a budget workout tracker should be able to track workouts beyond walking and running — otherwise, it would just be a pedometer. The number of activities a device will recognize varies. Some will get funky with it and consider skateboarding a workout, while others won’t be able to track a jumping jack.

At this price, you can expect a device to measure a mix of cardio, machine workouts and strength training. With each, you might get a numerical or visual breakdown of heart rate activity, overall pace, and calories burned per session. Although some cheap trackers can offer a really good overview of heart rate zone activity during a workout, a more technically advanced device might be able to go a step further and explain what your results mean and coach you on how to keep your heart rate in a specific bracket so that you can burn more fat per workout. I found that the more budget-friendly the device, the more likely it is that a tracker will fall short when it comes to smart counseling or offering predictive insights beyond a given workout. If a budget tracker does happen to offer some semblance of a coaching program, you can expect it to sit behind a paywall.

Tracking and planning your recovery is just as essential to any fitness journey. A sub-$100 device should be able to tell you how long you’ve slept and provide a breakdown of deep, light and REM sleep activity. It's not a guarantee that you will get a sleep “score” or insights on how to get better rest — that data is usually found on more expensive wearables. Also, because these trackers aren’t designed for bedtime specifically — be mindful of comfort. The bands and watch face on a budget fitness tracker may not be ideal for getting some good shut-eye.

Connectivity and practicality

Not all activity trackers, budget-friendly or not, are designed to seamlessly integrate with a smartphone. The trackers tested for this roundup can’t directly make calls or send texts to contacts on a paired smartphone. They can, however, display and dismiss incoming calls and notifications. You can forget about checking your email or paying for a coffee from your wrist using these more affordable devices.

Most cheap fitness trackers also won't include a built-in GPS. Instead, they usually depend on a paired smartphone to gather location data. The drawback of using a fitness tracker without GPS is that it might not provide as precise for tracking distance or pace. You also can't use a budget tracker to get turn-by-turn directions during a walk or while running errands. For the more outdoorsy consumers, having GPS could be a key safety feature.

Design

You also might find that an inexpensive fitness tracker is harder to navigate than a more advanced smartwatch. Whether it be a screen size issue or simply not having a smart enough interface, don't expect every feature to be one that you can engage with directly on your wrist. Oftentimes, you will need to pull out your smartphone to log information or access more in-depth health data.

The quality and build of displays and bands will also vary in this category. Don’t expect the highest resolution displays or the fanciest materials in the bands. But you can expect some level of sweat and water resistance.

Other cheap fitness trackers we tested

Wyze Watch 47c

I didn't have high expectations of the Wyze Watch 47c, but I was shocked at how little this tracker can do. The 47c can only track walks and runs. It has a dedicated widget, a small logo of a man running, and when you tap it, it begins measuring your pace, heart rate, calories burned and mileage. It does not auto-detect or auto-pause workouts and it doesn't differentiate between a run and walk. Most importantly, this device can’t track any other exercises. It’s basically a glorified pedometer.

The 47c was also my least favorite to sleep with, mainly because the square watch face is so large and heavy. Even if I did manage to sleep through the night with it on, it only gave me a basic sleep report.

Garmin vivofit 4

The Garmin vivofit 4 has a tiny display that is not a touchscreen and all navigation happens through one button. The watch face is impossible to read outdoors and the exercise widget is also very finicky. To start tracking a run, you have to hold down the main button and flip through some pages until you get to a moving person icon. Once there, you have to press the bottom right corner of the bar and hold down and if you press for too long or in the wrong spot, it’ll switch to another page, like a stopwatch. It’s incredibly frustrating.

Once you start a run though, it will start tracking your steps, your distance — and that's pretty much it. It does not auto-detect or auto-pause workouts. It doesn't alert you of any mileage or calorie milestones.

Researchers at MIT’s CSAIL division, which focuses on computer engineering and AI development, built two machine learning algorithms that can detect pancreatic cancer at a higher threshold than current diagnostic standards. The two models together formed to create the “PRISM” neural network. It is designed to specifically detect pancreatic ductal adenocarcinoma (PDAC), the most prevalent form of pancreatic cancer.

The current standard PDAC screening criteria catches about 10 percent of cases in patients examined by professionals. In comparison, MIT’s PRISM was able to identify PDAC cases 35 percent of the time.

While using AI in the field of diagnostics is not an entirely new feat, MIT’s PRISM stands out because of how it was developed. The neural network was programmed based on access to diverse sets of real electronic health records from health institutions across the US. It was fed the data of over 5 million patient’s electronic health records, which researchers from the team said “surpassed the scale” of information fed to an AI model in this particular area of research. “The model uses routine clinical and lab data to make its predictions, and the diversity of the US population is a significant advancement over other PDAC models, which are usually confined to specific geographic regions like a few healthcare centers in the US,” Kai Jia, MIT CSAIL PhD senior author of the paper said.

MIT’s PRISM project started over six years ago. The motivation behind developing an algorithm that can detect PDAC early has a lot to do with the fact that most patients get diagnosed in the later stages of the cancer’s development — specifically about eighty percent are diagnosed far too late.

The AI works by analyzing patient demographics, previous diagnoses, current and previous medications in care plans and lab results. Collectively, the model works to predict the probability of cancer by analyzing electronic health record data in tandem with things like a patient’s age and certain risk factors evident in their lifestyle. Still, PRISM is still only able to help diagnose as many patients at the rate the AI can reach the masses. At the moment, the technology is bound to MIT labs and select patients in the US. The logistical challenge of scaling the AI will involve feeding the algorithm more diverse data sets and perhaps even global health profiles to increase accessibility.

Nonetheless, this isn't MIT’s first stab at developing an AI model that can predict cancer risk. It notably developed a way to train models how to predict the risk of breast cancer among women using mammogram records. In that line of research, MIT experts confirmed, the more diverse the data sets, the better the AI gets at diagnosing cancers across diverse races and populations. The continued development of AI models that can predict cancer probability will not only improve outcomes for patients if malignancy is identified earlier, it will also lessen the workload of overworked medical professionals. The market for AI in diagnostics is so ripe for change that it is piquing the interest of big tech commercial companies like IBM, which attempted to create an AI program that can detect breast cancer a year in advance.

The US government has reportedly approved AI-based memory loss prediction software for the first time. Darmiyan, a San Francisco-based brain imaging analytics company, says the FDA has granted De Novo approval for its product BrainSee. The software platform assigns “an objective score that predicts the likelihood of progression from aMCI to Alzheimer’s dementia within 5 years,” according to the medical company. Fierce Biotech first reported the announcement.

Darmiyan says BrainSee can predict memory loss progression using clinical brain MRIs and cognitive tests, which are already standard for patients worried about early signs of decline. After the program analyzes the imaging and cognitive assessments, it assigns a predictive score indicating the patient’s odds of memory deterioration within the following five years. At least in theory, that would lead to early treatment for some and peace of mind for others.

“This shifts the patient experience from prolonged anxiety to proactive management, which is crucial in an era of emerging Alzheimer’s treatments where accurate prognosis can help determine suitable treatment candidates,” Darmiyan wrote in a press release announcing the FDA approval. “The economic impact of BrainSee will be significant for all stakeholders in healthcare, promising to reduce the billions of dollars annually spent on Alzheimer’s care, through more effective management and treatment.”

The FDA’s “De Novo” designation means the product has no clear market predecessors but has proven its effectiveness and safety in clinical trials. BrainSee first received FDA “breakthrough” designation in 2021, an earlier stage of the approval path for a first-of-its-kind treatment. 

Darmiyan says BrainSee is fully automated and provides results on the same day the scans and cognitive test scores are entered. The company views the tech as shifting the treatment of mild / early cognitive decline from biomarker-based methods to “non-invasive and actionable forecasts of future improvement or progression.”

Following last year's smart toilet which debuted at CES 2023, Vivoo is at it again for CES 2024 with another urine analysis product. The company has unveiled an at-home digital urinary tract infection (UTI) testing kit that provides what it calls "gold standard accuracy results" via a two-minute test. 

To use it, just pee on the provided UTI test strip and scan it to obtain results via Vivoo's app in "seconds," the company says. If the result is positive, customers can then connect with a doctor to obtain a prescription if required. The company says the product "saves customers time, prevents confusion in readings, and digitalizes the data so customers can share results with healthcare providers via the app, if instant treatment is desired." From the looks of it, the results are obtained via the strip, then deciphered by the app.

Vivoo notes that UTIs are the most common type of outpatient infection, with six in ten women experiencing them in their lifetimes. Normally, you'd send your urine off to a lab for analysis, or use an existing at-home test kit. The company says that the new product spares users the bureaucracy of lab testing while also keeping the relevant data for users who might need that, unlike regular testing kits. 

In fact, many women experience recurrent UTIs, which have become resistant to at least one or even multiple types of antibiotics. By keeping a record of past infections, Vivoo's app could help patients and medical professionals track the problem and treat it appropriately. 

Last year, the company unveiled a smart toilet device that clips onto existing toilets and provides data like your body's water, magnesium, PH, protein and sodium levels. Later on, it released strips for vaginal PH levels. The new home UTI test will come to market in Q2 2024, but pricing isn't yet available. 

We're reporting live from CES 2024 in Las Vegas from January 6-12. Keep up with all the latest news from the show here.

2023 was an important year for patients with sickle cell disease. Prior to CRISPR, the only cure for the life-long ailment was a bone marrow transplant, which is notoriously dangerous and costly. This month, the FDA approved Vertex’s “Casgevy,” a CRISPR-based therapy for the treatment of sickle cell disease in patients 12 and older. The landmark approval made the therapeutic the first genetically edited therapy to reach the general market.

Casgevy, which also received the greenlight from regulators in the UK for another blood disorder called beta thalassemia, works by being administered in a single-infusion of genetically modified stem cells to a patient. Clinical study participants that took Casgevy were free from symptoms associated with sickle cell disease, like periodic episodes of extreme pain due to blocked blood flow through vessels, for up to a year.

CRISPR, which modifies precise regions of a human’s DNA strands, was once thought to be a far off scientific innovation. Human cells were first modified using CRISPR in clinical trials in China back in 2016. Less than a decade later, these landmark approvals have set the stage for future nods by regulators for other CRISPR-based therapies that can treat things like HIV, cancers and high blood pressure. “Gene therapy holds the promise of delivering more targeted and effective treatments,” Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research said in a recent press release.

ASSOCIATED PRESS

CRISPR-based gene editing can be designed as a therapeutic for a number of diseases. A scientist can either delete, disrupt or insert segments of DNA to treat conditions by either targeting specific genes or engineering new cell therapies. The editing process can occur ex vivo (outside the body), in the same way Casgevy does, or in vivo (inside the body). Using CRISPR, sickle cell patients’ blood stem cells are modified in a lab before they are re-infused via a single-dose infusion as part of a hematopoietic transplant.

Neville Sanjana, a core faculty member at the New York Genome Center and associate professor in the Department of Biology at New York University, runs the Sanjana lab, which develops gene therapies for complex diseases like autism and cancer. “One of the really fundamental characteristics of CRISPR is its programmability,” Sanjana told Engadget. While working at the Zhang lab at the Broad Institute of MIT and Harvard, Sanjana says he helped design the “guide RNA” that became the blueprint for Vertex’s Casgevy. “CRISPR screens can be powerful tools for understanding any disease or genetic trait,” Sanjana said. Right now, he said biomedical folks are focused on applying CRISPR-based therapies for really serious inheritable diseases.

While it does “set a precedent” to have these first CRISPR-based gene therapies out there, it could also mean that regulators and the general public will regard future innovations in the space as “less novel,” Katie Hasson, a researcher with the Center for Genetics and Society (CGS) told Engadget. The CGS is a public interest and social justice organization that is focused on making sure gene editing is developed and distributed for good. Hasson explained, it doesn't mean that because one got approved that all other innovative therapies to come after it will not get as much scrutiny.

Beyond therapeutics, gene editing has very broad applications for the discovery and understanding of diseases. Scientists can use CRISPR to explore the origins of things like cancer and pave paths for therapeutics and incurable diagnoses, but that's not all there is to it. Scientists still need to conduct “considerable experimental research” when it comes to bringing an actual therapeutic to fruition, Sanjana said. “When we focus on therapeutic activity at a particular site in the genome, we need to make sure that there will not be any unintended consequences in other parts of the genome.”

Still, the spotlight will always shine a brighter light on the flashy developments of CRISPR from a therapeutic standpoint. Currently, a new gene editing method is being developed to target specific cells in a process called “cancer shredding“ for difficult-to-treat brain cancer. Scientists have even discovered a pathway to engineer bacteria to discover tumorous cells. However, there are barriers to using CRISPR in clinical practice due to the lack of “safe delivery systems to target the tissues and cells.”

“Maybe by curing one disease, you might give them a different disease — especially if you think of cancer. We call that a secondary malignancy,” Sanjana said. While there is strong reason for concern, one cure creating a pathway for other diseases or cancers is not unique to CRISPR. For example, CAR T cell therapy, which uses an entirely different approach to cell-based gene therapy and is not reflective of CRISPR, is a lifesaving cancer treatment that the FDA discovered can, in certain situations, cause cancer.

“We definitely don't want any unintended consequences. There are bits of the genome that if you edit them by mistake, it's probably no big deal but then there are other genes that are vitally important,” Sanjana said. Direct assessment of “off-target effects” or events in which a gene edit incorrectly edits another point on a DNA strand in vivo is challenging.

The FDA recommends that after a clinical trials’ period of investigatory study looking at the efficacy of a gene editing-based therapy, there needs to be a 15-year long term follow up after product administration. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that the agency’s approval of Casgevy follows “rigorous evaluations of the scientific and clinical data.” Right now, researchers are focused on improving the precision and accuracy of gene editing and having the proper follow up is absolutely well merited, Sanjana explained. “The process right now is a careful one.”

Hasson believes that the 15-year recommendation is a good start. “I know that there is a big problem overall with pharmaceutical companies actually following through and doing those long term post-market studies.”

That’s where new approaches come into play. Base editing, a CRISPR-derived genome editing method that makes targeted changes to DNA sequences, has been around since 2016. Drugs that use base editing have already made headway in the scientific community. Verve Therapeutics developed a gene edited therapy that can lower cholesterol in patients with a single infusion. At higher doses, Verve said the treatment has the potential to reduce proteins associated with bad cholesterol for 2.5 years. Base editing, like CRISPR, has many potential applications for treatment and discovery. For example, base editing could repair a gene mutation that causes childhood blindness. Researchers at Weill Cornell Medicine also found base editing could help understand what genetic changes influence a patient’s response to cancer therapies.

Base editors use CRISPR to bring another functional element to a specific place in the genome. “But it doesn't matter whether it's CRISPR cutting or base editing… any time you're modifying DNA…you would want to know what the off target effects are and you can bet that the FDA wants to know that too. You're going to need to collect data using standard models like cell culture, or animal models to show there are zero or near zero off-target impacts,” Sanjana said.

CRISPR-based therapies already show high therapeutic potential for conditions beyond sickle cell disease. From blood based treatments, to edited allogeneic immune cells for cancers, there are a number of human clinical trials underway or expected to start next year. Trials for gene-edited therapies that target certain cells for cancer and autoimmune diseases are expected to begin in 2024.

Boston Globe via Getty Images

It won't be until 2025 before we get a better understanding of how Excision BioTherapeutics’ CRISPR-based therapy works to treat HIV. The application of gene editing as a therapeutic for Alzhiemer’s is still in the early stages, with mice at the forefront of research. Similarly, University College London researchers proved that CRISPR has promise as a potential therapeutic for treatment-resistant forms of childhood epilepsy. In a recent study, a gene edited therapy developed in the lab was shown to reduce seizures in mice.

But the clinical process of getting CRISPR to safely and effectively work as it's intended isn’t the only hurdle. The pricing of CRISPR and related therapies in general will be a huge barrier to access. The Innovative Genomics Institute (IGI), a research group that hopes to advance ethical use of these gene editing in medicine, estimates that the average CRISPR-based therapy can cost between $500,000 and $2 million per patient. The IGI has built out an “Affordability Task Force” to tackle the issue of expanding access to these novel therapies. Vertex’s sickle cell treatment costs a cool $2.2 million per treatment, before hospital costs. David Altshuler, the chief scientific officer at Vertex, told MIT Tech Review that wants to innovate the delivery of the therapeutic and make it more accessible to patients. “I think the goal will be achieved sooner by finding another modality, like a pill that can be distributed much more effectively,” Altshuler said.

“Access is a huge issue and it's a huge equity issue,” the CGS’ Hasson told Engadget. “I think we would also like to look at equity here even more broadly. It's not just about who gets access to the medication once it comes on the market but really how can we prioritize equity in the research that's leading to these treatments.” The US already does a poor job of providing equitable healthcare access as it is, Hasson explained, which is why it's important for organizations like CGS to pose roundtable discussions about implementing guardrails that value ethical considerations. “If you support people having access to healthcare, it should encompass these cutting edge treatments as well.”

A Senate Finance Committee inquiry revealed on Tuesday that police departments can get access to private medical information from pharmacies, no warrant needed. While HIPAA may protect some access to personally identifiable health data, it doesn't stop cops, according to a letter from Senator Ron Wyden, Representative Pramila Jayapal and Representative Sara Jacobs to the Department of Health and Human Services. None of the major US pharmacies are doing anything about it, either, the members of Congress say. 

"All of the pharmacies surveyed stated that they do not require a warrant prior to sharing pharmacy records with law enforcement agents, unless there is a state law that dictates otherwise," the letter said. "Those pharmacies will turn medical records over in response to a mere subpoena, which often do not have to be reviewed or signed by a judge prior to being issued."

The committee reached out to Amazon, Cigna, CVS Health, The Kroger Company, Optum Rx, Rite Aid Corporation, Walgreens Boots Alliance and Walmart about their practices for sharing medical data with police. While Amazon, Cigna, Optum, Walmart and Walgreen said they have law enforcement requests reviewed by legal professionals before complying, CVS Health, The Kroger Company and Rite Aid Corporation said they ask in-store staff to process the request immediately. Engadget reached out to the pharmacies mentioned in the letter about the claims. CVS said its pharmacy staff are trained to handle these inquiries and its following all applicable laws around the issue. Walgreens said it has a process in place to assess law enforcement requests compliant with those laws, too, and Amazon said while the law enforcement requests are rare, it does notify patients and comply with court orders when applicable. The others either haven't responded or refuse to comment.

The pharmacies mostly blamed the current lack of legislative protections for patient data for their willingness to comply with cop requests. Most of them told the committee that current HIPAA law and other policies let them disclose medical records in response to certain legal requests. That's why the Senate Finance Committee is targeting HHS to strengthen these protections, especially since the 2023 Dobbs decision let states criminalize certain reproductive health decisions. 

Under current HIPAA law, patients have the right to know who is accessing their health information. But individuals have to request the medical record disclosure data, instead of health care professionals being required to share it proactively. "Consequently, few people ever request such information, even though many would obviously be concerned to learn about disclosures of their private medical records to law enforcement agencies," the letter states. The letter also urges pharmacies to change their policies to require a warrant, and publish transparency reports about how data is shared. 

In a landmark decision, the FDA greenlit two new drugs for the treatment of sickle cell disease in patients 12 and older, one of which —Vertex’s drug Casgevy — is the first approved use of genome editing technology CRISPR in the US. Bluebird Bio’s Lyfgenia also is a cell-based gene therapy, however, it uses a different gene modification technique to deliver tweaked stem cells to the patient.

Both approvals cultivate new pathways for the treatment of sickle cell disease, which is an inherited blood disorder that is characterized by red blood cells that can’t properly carry oxygen, which leads to painful vaso-occlusive crises (VOCs) and organ damage. The disease is particularly common among African Americans and, to a lesser extent, among Hispanic Americans. Bone marrow transplants are currently the only cure for sickle cell disease, but they require well-matched donors and often involve complications.

While both drug approvals use gene editing techniques, Casgevy’s CRISPR/Cas9 genome editing works by cutting out or splicing in DNA in select areas. Patients first have blood drawn so that their own stem cells can be isolated and edited with CRISPR. They then undergo a form of chemotherapy to remove some bone marrow cells, so the edited stem cells can be transplanted back in a single infusion.

Both drug approvals are based on studies that evaluated the effectiveness and safety of the novel therapies in clinical patients. With Casgevy, study participants reported that they did not experience “severe VOCs” for at least 12 consecutive months during the 24-month follow-up. Similarly, patients on Lyfgenia did not experience a “pain crisis” for six to 18 months after the therapy.

The FDA's decision comes shortly after UK regulators, as well as the National Health Regulatory Authority in Bahrain both approved Vertex’s Casgevy. The approval for a CRISPR-based treatment creates opportunity for further innovation in the gene editing space — for treatments ranging from cancers to heart diseases to Alzheimer’s. “Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited,” Nicole Verdun, director of the Office of Therapeutic Products at the FDA’s Center for Biologics Evaluation and Research said. Casgevy is still currently under review by the European Medicines Agency.

MIT researchers developed an ingestible capsule that can monitor vital signs including heart rate and breathing patterns from within a patient’s GI tract. The scientists also say that the novel device has the potential to also be used to detect signs of respiratory depression during an opioid overdose. Giovanni Traverso, an associate professor of mechanical engineering at MIT who has been working on developing a range of ingestible sensors, told Engadget that the device will be especially useful for sleep studies.

Conventionally, sleep studies require patients to be hooked up to a number of sensors and devices. In labs and in at-home studies, sensors can be attached to a patient’s scalp, temples, chest and lungs with wires. A patient may also wear a nasal cannula, chest belt and pulse oximeter which can connect to a portable monitor. “As you can imagine, trying to sleep with all of this machinery can be challenging,” Traverso told Engadget.

MIT

This trial, which used a capsule made by Celero Systems —A start-up led by MIT and Harvard researchers— marks the first time ingestible sensor technology was tested in humans. Aside from the start-up and MIT, the research was spearheaded by experts at West Virginia University and other hospital affiliates.

The capsule contains two small batteries and a wireless antenna that transmits data. The ingestible sensor, which is the size of a vitamin capsule, traveled through the gastrointestinal tract, and collected signals from the device while it was in the stomach. The participants stayed at a sleep lab overnight while the device recorded respiration, heart rate, temperature and gastric motility. The sensor was also able to detect sleep apnea in one of the patients during the trial. The findings suggest that the ingestible was able to measure health metrics on par with medical-grade diagnostic equipment at the sleep center. Traditionally, patients that need to get diagnosed with specific sleep disorders are required to stay overnight at a sleep lab, where they get hooked onto an array of sensors and devices. Ingestible sensor technology eliminates the need for that.

Importantly, MIT says there were no adverse effects reported due to capsule ingestion. The capsule typically passes through a patient within a day or so, though that short internal shelf life may also limit how effective it could be as a monitoring device. Traverso told Engadget that he aims to have Celetro, which he co-founded, eventually contain a mechanism that will allow the capsule to sit in a patient’s stomach for a week.

Dr. Ali Rezai, the executive chair of the West Virginia University Rockefeller Neuroscience Institute, said that there is a huge potential for creating a new pathway through this device that will help providers identify when a patient is overdosing according to their vitals. In the future, researchers even anticipate that devices could incorporate drugs internally: overdose reversal agents, such as nalmefene, could be slowly administered if a sensor records that a person’s breathing rate slowed or stopped. More data from the studies will be made available in the coming months.

In a landmark decision, the UK’s Medicines and Healthcare products Agency (MHRA) approved the use of a gene-editing therapy called Casgevy for patients with sickle cell disease and beta thalassemia — both of which are hereditary disorders related to genetic mutations of the red blood cells. The treatment, manufactured by Vertex, is the first-ever approved therapy that utilizes CRISPR-based gene editing technology to treat eligible patients.

The UK approval of the novel therapy is informed by two previous global clinical trials that indicated the treatment's efficacy. 97 percent of patients using Casgevy were relieved of severe pain associated with the blood disorders for at least 12 months after treatment during the trials. The results suggest that the gene editing treatment could replace the current standard for care. Stem cell therapy and bone marrow transplants are currently the only pathways to cure sickle cell disease and beta thalassemia, however, they involve a lot of risks.

Both sickle cell disease and beta thalassemia are blood disorders characterized by defective red blood cells that can’t carry oxygen, and require patients to get monthly blood transfusions that can be costly and time-consuming. Casgevy works by specifically targeting the genes in the bone marrow stem cells that produce faulty blood cells. For the treatment to work, a patient’s stem cells need to be extracted from their bone marrow, edited in a lab and then re-infused into the patient.

Despite its promising outlook, CRISPR-based therapies may not be easily available to the general public. Gene editing is an expensive endeavor. The Innovative Genomics Institute (IGI) estimates that the average CRISPR-based therapy will cost between $500,000 and $2 million per patient. The IGI has built out an ‘Affordability Task Force’ to tackle the issue of expanding access to these novel therapies.

Aside from costliness, gene editing therapies offer huge promise to innovate treatment pathways for rare conditions including neurodegenerative diseases, cancer and muscular atrophy. More importantly, this landmark approval for Casgevy “opens the door for further applications of CRISPR therapies in the future,” Prof Dame Kay Davies, a scientist from the University of Oxford, said. And new iterations of gene editing technologies may even surpass CRISPR in the future.

Casgevy is still being reviewed by regulatory agencies for safety standards in other countries, including the United States and Saudi Arabia. A marketing application, the first step towards approval for the therapy, was recently validated by the European Medicines Agency.