Biogen and Sage Therapeutics' collaboration to develop Zurzuvae has proved fruitful. The FDA approved the oral pill specifically for the treatment of postpartum depression (PPD), making it the first of its kind in a class of antidepressants intended specifically for new mothers. According to research by the CDC, one in eight women will experience symptoms of postpartum depression. Symptoms of PPD can occur quite intensely after birth and can be dangerous because it can interfere with a new mother’s ability to function. The long-awaited approval comes thanks to two randomized, double-blind studies that proved the efficacy of the drug.

A key hallmark of Zurzuvae is that the medication is expected to work within just a few days and is meant to be taken for up to two weeks. Before this once-daily oral pilll, the most common treatment plan for PPD required an IV injection. That meant administration by a healthcare provider in a hospital or healthcare facility was necessary. With this approval, Zurzuvae will be able to expand access and reach to more women on their way out of hospitals.

The catch is the drug can impact a patient's ability to drive and cause extreme drowsiness. Additionally, the warning label for the drug highlights that, like most antidepressants, the drug can cause an increased risk for suicidal ideation. To top it off, Zurzuvae may also cause fetal harm. Patients on the drug should use contraception while taking the pill and for one week after taking Zurzuvae.

Johnson & Johnson's Medical technology arm received FDA approval for a new workflow that will make it safer for medical professionals to treat atrial fibrillation, a condition that makes your heartbeat irregular and can cause stroke or heart failure. Several products developed by Biosense Webster, which is part of J&J MedTech, got the OK for a "zero fluoroscopy workflow" from the FDA, meaning live X-ray imaging will no longer be needed during catheter insertion procedures. Instead of using X-rays to insert Biosense catheters, medical professionals can now use ultrasound to guide treatments.

Using fewer X-rays, or fluoroscopy, lowers radiation exposure for both patients and medical professionals. Currently, doctors and medical staff who work in treatment rooms that specialize in treating relevant heart procedures often get too much exposure to radiation over time, which can lead to problems like eye issues, cancer, and bone injuries. This FDA approval helps address the recurring occupational hazard. Providers working in cath labs also won't have to wear heavy protective gear like lead aprons anymore when applying the newly approved workflow, reducing the risk of long-term muscle and bone pain.

This move by the FDA marks the first and only approval of its kind. The thumbs up was based on data from clinical trials and research from the REAL AF Registry, or the real-world evidence registry in the electrophysiology field. The data backed how well the treatment works in real-life situations. The new method will only apply for Biosense products like the THERMOCOOL SMARTTOUCH SF catheter, the most commonly used ablation catheter, among others.

A newly published study in the the Lancet Oncology journal has found that the use of AI in mammogram cancer screening can safely cut radiologist workloads nearly in half without risk of increasing false-positive results. In effect, the study found that the AI’s recommendations were on par with those of two radiologists working together.

“AI-supported mammography screening resulted in a similar cancer detection rate compared with standard double reading, with a substantially lower screen-reading workload, indicating that the use of AI in mammography screening is safe,” the study found.

The study was performed by a research team out of Lund University in Sweden and, accordingly, followed 80,033 Swedish women (average age of 54) for just over a year in 2021-2022 . Of the 39,996 patients that were randomly assigned AI-empowered breast cancer screenings, 28 percent or 244 tests returned screen-detected cancers. Of the other 40,024 patients that received conventional cancer screenings, just 25 percent, or 203 tests, returned screen-detected cancers.

Of those extra 41 cancers detected by the AI side, 19 turned out to be invasive. Both the AI-empowered and conventional screenings ran a 1.5 percent false positive rate. Most impressively, radiologists on the the AI side had to look at 36,886 fewer screen readings than their counterparts, a 44 percent reduction in their workload.

“These promising interim safety results should be used to inform new trials and program-based evaluations to address the pronounced radiologist shortage in many countries, but they are not enough on their own to confirm that AI is ready to be implemented in mammography screening," lead author, Dr Kristina Lång, warned in a release. “We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology.”

Cancer detection has been an aspirational goal for computer vision researchers and AI companies for years now. I mean, who doesn’t want to be the company to build the tricorder that infallibly spots cancerous growths in their earliest stages? Machine vision systems designed for these screenings have improved steadily in recent years and in specific cases have shown to be as reliable as human clinicians, with the likes of IBM, Google, MIT and NVIDIA investing in similar cancer screening research in recent years.

Keith Thomas from New York was involved in a driving accident back in 2020 that injured his spine's C4 and C5 vertebrae, leading to a total loss in feeling and movement from the chest down. Recently, though, Thomas had been able to move his arm at will and feel his sister hold his hand, thanks to the AI brain implant technology developed by the Northwell Health's Feinstein Institute of Bioelectronic Medicine. 

The research team first spent months mapping his brain with MRIs to pinpoint the exact parts of his brain responsible for arm movements and the sense of touch in his hands. Then, four months ago, surgeons performed a 15-hour procedure to implant microchips into his brain — Thomas was even awake for some parts so he could tell them what sensations he was feeling in his hand as they probed parts of the organ. 

While the microchips are inside his body, the team also installed external ports on top of his head. Those ports connect to a computer with the artificial intelligence (AI) algorithms that the team developed to interpret his thoughts and turn them into action. The researchers call this approach "thought-driven therapy," because it all starts with the patient's intentions. If he thinks of wanting to move his hand, for instance, his brain implant sends signals to the computer, which then sends signals to the electrode patches on his spine and hand muscles in order to stimulate movement. They attached sensors to his fingertips and palms, as well, to stimulate sensation. 

Thanks to this system, he was able to move his arm at will and feel his sister holding his hand in the lab. While he needed to be attached to the computer for those milestones, the researchers say Thomas has shown signs of recovery even when the system is off. His arm strength has apparently "more than doubled" since the study began, and his forearm and wrist could now feel some new sensations. If all goes well, the team's thought-driven therapy could help him regain more of his sense of touch and mobility. 

While the approach has a ways to go, the team behind it is hopeful that it could change the lives of people living with paralysis. Chad Bouton, the technology's developer and the principal investigator of the clinical trial, said:

"This is the first time the brain, body and spinal cord have been linked together electronically in a paralyzed human to restore lasting movement and sensation. When the study participant thinks about moving his arm or hand, we ‘supercharge’ his spinal cord and stimulate his brain and muscles to help rebuild connections, provide sensory feedback, and promote recovery. This type of thought-driven therapy is a game-changer. Our goal is to use this technology one day to give people living with paralysis the ability to live fuller, more independent lives."

GoodRx, best known for its prescription drug price comparison tool, has launched a new free offering called “Medicine Cabinet.” The tool will allow GoodRx app users to manage their prescription medications on a single platform. This comes on the heels of the news that the company is working with CVS Health to develop the Caremark Cost Saver, which could lower pharmacy out-of-pocket drug costs for shoppers.

Medicine Cabinet will automatically integrate within the GoodRx app and will feature tools like a “prescriptions dashboard” where a consumer can set up refill reminders and find the best pharmacies to pick up their medications at the lowest price. At the heart of the app are daily pill reminders that are customizable to any treatment plan that is uploaded into the app. GoodRx Chief Product Officer Mark Hull said the reminders feature is huge because 50 percent of the time, Americans are struggling to take their medications as prescribed for reasons as simple as forgetfulness or cost.

The Medicine Cabinet also includes a dashboard for GoodRx’s rewards program which offers users monetary perks like e-gift cards for staying on top of medication refills. “Nobody's integrating or rewarding people for having those healthy habits,” Hull said.

“What we've found is that the winning model for us is to marry the discounts, the value and the rewards, with the basic healthy habits and reminder stuff,” he added. GoodRx claims it can save consumers up to 80 percent off the price of prescription drugs by partnering with pharmacy benefits managers to negotiate deals on drugs. Normally, the average consumer wouldn’t otherwise have access to these discounts without middlemen like GoodRx.

GoodRx

The Medicine Cabinet tool has only been in development for roughly six months and will be available on iOS, but not on Android just yet.

“GoodRx was able to develop Medicine Cabinet so quickly in part due to the data it has already amassed from users and providers over the last decade.” "If a startup were doing this, it would take a long time, they don't have the data, they don't have the relationships with retailers, they don't already have the customer base," Hull said. “We already have a half a billion prescriptions in federal records from the millions of people who have been using us for the last 12 plus years.”

Hull said he actually wishes Medicine Cabinet could have come sooner. He recalls when his stepfather had a heart attack a couple of years ago. "When he came home from the hospital, he had like a dozen medications he had to manage," Hull said, remembering it as a nerve wracking time for his family and specifically his mother. "For the average person who's managing a condition with multiple medications, it's a lot of work and so we're really trying to make it simple, clear and obvious what you need to do at any given point to help manage your condition."

GoodRx

Down the line, Hull hopes Medicine Cabinet will be easier for older people to use, with the inclusion of features that will let a user take a photo of a medication instead of having to look it up in the database.

Still, GoodRx's history of being caught up in legal trouble related to data privacy issues is worth noting. Earlier this year, the Federal Trade Commission fined the company for the unauthorized disclosure of customers' identifiable health information with third parties, such as Facebook and Google. “Our privacy policy applies to Medicine Cabinet, which sits within the GoodRx app. We are very transparent about what information we collect and how we use it to personalize and customize our products for consumers. Additionally, the feature is only available for users who have registered for a GoodRx account,” a representative said. The company’s recent focus on transparency and adherence to privacy policies suggest it's taking the issue seriously, though as with any telehealth company, data privacy will always be a front and center concern.

Google is already testing its Med-PaLM 2 AI chat technology at at the Mayo Clinic and other hospitals, The Wall Street Journal has reported. It's based on the company's PaLM 2 large language model (LLM) that underpins Bard, Google's ChatGPT rival — and was launched just months ago at Google I/O. 

Unlike the base model, Med-PaLM-2 has been trained on questions and answer from medical licensing exams, along with a curated set of medical expert demonstrations. That gives it expertise in answering health-related questions, and it can also do labor-intensive tasks like summarizing documents and organizing research data, according to the report. 

During I/O, Google released a paper detailing its work on Med-PaLM2. On the positive side, it demonstrated features like "alignment with medical consensus," reasoning ability, and even the ability to generate answers that were preferred by respondents over physician-generated responses. More negatively, it showed the same accuracy problems we've seen on other Chat AI models. 

Microsoft is also developing medical AI chat tech based on OpenAI's ChatGPT, having teamed up with the healthcare software company Epic. Google is also working on using its AI for ultrasound diagnosis and cancer therapy, it revealed in March. Both companies have promised to keep patient information confidential, saying they don't train their models on patient data. Last month, Microsoft expressed alarm about its ChatGPT technology being used by doctors to improve communications with patients. 

In an internal email seen by the WSJ, Google said it believes the updated model could "be of tremendous value in countries that have more limited access to doctors." Still, Google has admitted that the technology is still in its early stages. "I don’t feel that this kind of technology is yet at a place where I would want it in my family’s healthcare journey," said Google senior research director Greg Corrado. However, he added that the tech "takes the places in healthcare where AI can be beneficial and expands them by 10-fold." 

It's probably fair to say that when most people conjure images of the pharmaceutical industry, it's not often there's an association between the production of life-saving drugs and environmental decline. But according to one 2019 study by The Conversation, drug companies produce more tonnes of carbon dioxide equivalents per million dollars than the automotive industry. "By our calculations, the pharma market is 28 percent smaller yet 13 percent more polluting than the automotive sector," the outlet said of the state of the pharmaceutical industry in 2015. Put another way: drug companies need to reduce their carbon emissions for the health of the planet and everyone living on it.

Thankfully, a group of scientists from the University of Bath in the United Kingdom may have found a way for the industry to do exactly that. In a study published in the journal ChemSusChem, the team describes a process they created for converting β-pinene, a component found in turpentine, into pharmaceutical precursors that they then used to synthesize paracetamol and ibuprofen. Right now, most companies producing those painkillers use chemical precursors derived from crude oil. Turpentine, meanwhile, is a waste by-product the paper industry makes at a scale of more than 350,000 metric tonnes per year. The researchers say they also successfully used turpentine to synthesize 4-HAP, a precursor for beta-blockers, the asthma inhaler drug salbutamol and a range of household cleaners.

In addition to being more sustainable, the team's "bio-refinery" process could lead to more consistent drug costs for consumers since turpentine isn't subject to the same geopolitical pressures that can send energy and oil prices skyrocketing. However, a significant pitfall of the process in its current form is that it costs more to produce drugs with turpentine than crude oil. The team suggests consumers may be willing to pay slightly higher prices for more sustainable drugs, but let's be honest, when someone is sick or in pain, paying more for relief is the last thing most people want to do.

Japanese drugmaker Eisai and US-based Biogen have been working together on advancing research in the space of Alzheimer’s for nearly a decade. Finally, the FDA, granted the fruits of that labor, Leqembi, its blessing for intravenous use. This marks the first approved treatment that can slow the progression of Alzheimer’s.

Leqembi received a preliminary approval in January that allowed it to be used in a limited capacity. That approval was conditioned on the two drug makers conducting a confirmatory study to verify the drug's clinical benefit.

Though Leqembi slows Alzihmer’s progression, it is not a cure. Instead, it addresses the underlying biology that spurs Alzheimer's advancement. The drug works by reducing amyloid plaques, or "misfolded" proteins that form in the brain of a person with Alzheimer's.

Leqembi isn’t the only drug targeting beta-amyloid plaque buildup to treat Alzheimer's. Aduhelm received approval under the accelerated pathway in 2021, but it’s still not fully FDA-approved. But what sets Leqembi apart from its predecessor is that the drug demonstrated actual clinical benefit in addition to simply reducing the buildup of the AD-inducing proteins.

Besides needing a medical prescription, taking the drug will require professional administration in a hospital or infusion center every two weeks. The company, though it may not be its sole responsibility, recognizes its need to boost accessibility. In a public statement, Christopher Viehbacher, the CEO of Biogen, said the company’s main focus now is to work with Eisai to make Leqembi “accessible to eligible patients as soon as possible.”

The drug’s hefty price tag of $26,500 will unfortunately make it inaccessible to most. Current rules mean that it’s unlikely to be covered by Medicare. According to the Alzheimer's Association, those on Medicaid only should be able to get coverage of the FDA-approved drug in most cases. But, even if Medicaid does cover it, patients would be responsible for a 20 percent copay – or about $5,300. Experts predict the total cost of Leqembi treatment can run upward of $90,000 a year, if you take infusions and laboratory tests into account.

An expensive treatment program is something to consider for the one in nine Americans who are over the age of 65 that have Alzheimer’s dementia. That number is expected to grow as the nation’s aging population continues to grow. The number of Americans 65 and older is projected to climb from 58 million in 2021 to 88 million by 2050. This has led to an increased focus on treatments and diagnostics for Alzheimer’s, like blood tests that can detect the disease.

Owlet and its baby monitoring devices are back in the good graces of the FDA. The company received clearance from the US regulator for its product BabySat, a medical-grade pulse-ox monitor designed as a wireless “sock” for newborns and babies. The win comes after the FDA ordered the Utah-based biotech company to stop selling its smart sock almost 18 months ago.

The FDA objection was based on the fact that the wearable had the capacity to relay a live display of a baby’s heart rate and oxygen levels, which is critical data that a doctor should interpret, especially in vulnerable populations. The tumultuous approval demonstrates “our technology is medical-grade,” Kurt Workman, Owlet CEO and co-founder said of the company's path to getting FDA approval. “We conducted several side-by-side accuracy comparisons to hospital monitors and that demonstrated Owlet is accurate." The device can alert a provider if any metrics are out of range, which can help to diagnose and prevent complications.

Owlet stripped out the blood oxygen and pulse tracking features and returned to the market just a few months later with the Dream Sock. The $299 wearable is available direct from the company and through a number of other retailers without a prescription, but it lacks the advanced features that set it apart from the rest of its rivals. Instead, it’s a pretty straightforward sleep tracker.

BabySat, on the other hand, is a prescription device. It integrates medical-grade pulse oximetry technology into a discreet wearable. It’s a noninvasive tool to measure how well oxygen is circulating to extremities in babies from 1 to 18 months.

Without a prescription, a rival medical-grade device can not be readily found on the market, given that BabySat is the first device of its kind to receive FDA approval. Creating a treatment plan with a doctor is especially valuable and useful to the parents of babies that have been diagnosed with heart defects or chronic conditions. If a newborn or baby does present with persistent low oxygen levels, quick intervention by medical professionals is needed to prevent life-threatening complications.

Owlet anticipates the product will be available in the US by the end of this year. The company declined to disclose pricing information for BabySat but did say that insurance options, including reimbursements and HSA/FSA eligibility, will likely be available at launch.

Ingestible video capsule endoscopes have been around for a while, but they’re severely limited and not controllable by physicians, relying entirely on gravity and the digestive system for movement. Researchers may have just gotten around that limitation by developing a pill-shaped capsule that allows for remote control, as announced by the GW School of Medicine & Health Sciences.

This tech lets physicians quite literally drive a miniature video capsule, called the NaviCam, throughout the digestive system to visualize and photograph potential problem areas, offering a potential alternative to the traditional endoscopy. It uses an external magnet and video game style joysticks for movement.

“A traditional endoscopy is an invasive procedure for patients, not to mention it is costly due to the need for anesthesia and time off work,” Andrew Meltzer, a professor of Emergency Medicine at the GW School of Medicine & Health Sciences, said. “Magnetically controlled capsules could be used as a quick and easy way to screen for health problems in the upper GI tract such as ulcers or stomach cancer.”

This technology is still in the testing phase though results have been positive. Meltzer and colleagues at medical technology company AnX Robotica conducted a 40-person study and found that doctors could accurately control the capsule to all major parts of the stomach with a 95 percent rate of successful visualization. These patients also underwent a traditional endoscopy to confirm that the camera didn’t miss any high-risk lesions.

The potential benefits for patients are varied, as the camera’s designed to pick up bleeding, inflammation, and lesions. It can also automatically transmit videos and images off-site for further review. The official study indicates that using a camera capsule offers no health risks, though the tech doesn’t allow for biopsies, as it degrades inside of the body. Researchers note this pilot testing program is still in the beginning stages and a “much bigger trial with more patients” is on the horizon.