Turns out Elon Musk's FDA prediction was only off by about a month. After reportedly denying the company's overtures in March, the FDA approved Neuralink's application to begin human trials of its prototype Link brain-computer interface (BCI) on Thursday. 

Founded in 2016, Neuralink aims to commercialize BCIs in wide-ranging medical and therapeutic applications — from stroke and spinal cord injury (SCI) rehabilitation, to neural prosthetic controls, to the capacity "to rewind memories or download them into robots," Neuralink CEO Elon Musk promised in 2020. BCIs essentially translate the analog electrical impulses of your brain (monitoring it using hair-thin electrodes delicately threaded into that grey matter) into the digital 1's and 0's that computers understand. Since that BCI needs to be surgically installed in a patient's noggin, the FDA — which regulates such technologies — requires that companies conduct rigorous safety testing before giving its approval for commercial use. 

In March, the FDA rejected Neuralink's application to begin human trials reportedly in part due to all the test animals that kept dying after having the prototype BCI implanted. According to internal documents acquired by Reuters in December, more than 1,500 animals had been killed in the development of the Neuralink BCI since 2018. The US Department of Agriculture's (USDA) Inspector General has since launched an investigation into those allegations.  

The FDA's reticence was also born from concerns about the design and function of the interface when implanted in humans. "The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue," current and former Neuralink employees told Reuters in March.

While Neuralink has obtained FDA approval to begin its study, the company is not yet seeking volunteers. This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people," Neuralink Tweeted on Thursday. "Recruitment is not yet open for our clinical trial."  

Universal Music Group (UMG) is partnering with Endel, an “AI sound wellness company” specializing in personalized algorithmic soundscapes, the companies announced today. The partnership aims to let UMG artists create machine-learning-generated sounds for activities like sleep, relaxation and focus. Endel previously partnered with synth-pop artist Grimes on a lullaby app.

The record label “will use Endel’s proprietary AI technology to enable UMG artists to create science-backed soundscapes,” the companies said. The soundscapes can contain new music and updated versions of back-catalog tracks. The companies emphasize that the project “will always respect creators’ rights and put artists at the center of the creative process,” adding that musicians and their teams have the final say on the results. UMG and Endel say they’ll announce “the first wave of soundscapes” from the partnership in the coming months.

Endel uses artist stems to make soundscapes “driven by scientific insights into how music affects our mind-state.” The companies describe the collaboration as a way to “provide artists and rights holders new opportunities to generate additional revenue for their catalogs” while letting performers dip their toes into new areas and “support wellness for the listener.” But it’s hard not to see the irony of UMG quickly stomping out AI-generated music that threatens its business model — like when fake Drake and The Weeknd tracks went viral — while putting out rapturous press releases when it sees a potential profit. (Although, to be fair, cloning artists’ voices without their permission would never fly for long, regardless of UMG’s response.)

“At UMG, we believe in the incredible potential of ethical AI as a tool to support and enhance the creativity of our artists, labels and songwriters, something that Endel has harnessed with impressive ingenuity and scientific innovation,” said Michael Nash, EVP and Chief Digital Officer at UMG. “We are excited to work together and utilize their patented AI technology to create new music soundscapes — anchored in our artist-centric philosophy — that are designed to enhance audience wellness, powered by AI that respects artists’ rights in its development.”

It can cost billions of dollars to develop drugs and a large percentage fail at the trial stage, so a number of companies are deploying AI to help in that area. Google's Cloud division is the latest to join that race with two new suites aimed at addressing drug discovery while advancing precision medicine, it announced. 

The Target and Lead Identification Suite aims to help drug companies better understand proteins and amino acids that are key to drug development. Specifically, it's designed to help scientists identify biological targets that researchers can develop treatments around. This could effectively speed up drug discovery and lower costs. 

Early adopters for the suite "include multinational pharmaceutical companies like Pfizer and industry-leading biotech companies including Cereval," Google Cloud wrote in a press release. "We are partnering with Google on exploring how AlphaFold2 can potentially accelerate our drug discovery process, speeding up our researchers' ability to conduct their experiments on Google Cloud's scalable, accelerator-optimized compute platform," said Pfizer's principal computational scientist, Nicholas Labello. 

Meanwhile, the Multiomics Suite is designed to tackle genomic data analysis. The idea is to find out how genetic variations affect disease in order to create appropriate and even personalized treatments. Genomic databases tend to be enormous, so the suite would give researchers fast access to the appropriate data, helping accelerate treatments. 

"We would not be anywhere near where we are today" without the tool, Colossal Biosciences CEO Ben Lamm told CNBC. That company has been an early adopter of Multiomics, and Lamm said it would have been a "massive burden" for Colossal to try to build something similar itself. 

Apple devices can already offer health insights, but they might soon tell you just how to improve. Bloombergsources claim Apple is developing an AI-based health coach, nicknamed Quartz, that draws on Apple Watch data to create personalized programs for exercise, diet and sleep. The offering will reportedly require a subscription and launch sometime in 2024, provided nothing changes.

In the near term, the Health app may become more useful. Apple is finally bringing Health to the iPad with this year's iPadOS 17 release, the insiders say. A further update will supposedly help you track your mood by answering questions about your day. You may also use Health to manage vision issues like nearsightedness. A recent rumor also hinted that Apple may release a journaling app to help document your days, much like Day One.

Apple has already declined to comment. If the claims are accurate, you'll most likely hear about all but the coach at WWDC on June 5th. The company is expected to unveil its long-expected mixed reality headset at the developer event, and rumors suggest the wearable may offer health-related features like a VR edition of Fitness+ and a meditation tool. This initial product would be aimed at developers and power users, but a more affordable follow-up is believed to be in the works.

A coaching app wouldn't be shocking. Apple is still leaning heavily on services to improve its bottom line, and Quartz may be appealing to those who would otherwise pay for a human coach to rethink their habits. Apple has already made health a major selling point for its devices, particularly the Apple Watch. Of course, the coach could further entrench Apple users — you may be less likely to switch to Android if you have to give up your watch and digital trainer at the same time.

NVIDIA is deepening its efforts to fight cancer using AI. The GPU maker is teaming with Medtronic to build AI into the GI Genius endoscopy tool (shown below). The two will use NVIDIA's IGX hardware and Holoscan medical platform to help detect the polyps that can lead to colorectal cancer. Doctors will get "AI-enhanced" diagnostic images, the companies say.

The first GI Genius systems built with NVIDIA tech are expected to arrive later this year. The device can use a range of AI tools, and Medtronic is betting that using NVIDIA's Clara platform could help develop algorithms for real-time medical procedures.

Medtronic

The news comes the same time as NVIDIA is expanding its BioNeMo Cloud service that helps bring generative AI to drug discovery. The new offering helps train AI models (and handle inference) used to develop new therapeutic proteins and otherwise advance fields like biology and chemistry. Researchers can speed up one of the most time-consuming processes in their pipeline, NVIDIA claims.

The news comes soon after Google unveiled AI technology for cancer therapy and ultrasound diagnosis. Other tech giants have devoted more of their AI work to healthcare in recent years. Intel partnered with Penn Medicine on AI to detect brain tumors, while Microsoft aimed to speed up cervical cancer detection and take some of the load from overworked doctors.

For NVIDIA, this is as much about translating its AI expertise to health tech as it is winning another customer. Still, the alliance could lead to some very practical benefits. As with some other AI-based cancer detection systems, this could help physicians begin treatment early and increase the chances of recovery.

Researchers at the University of New South Wales, Sydney, have developed a flexible 3D bioprinter that can layer organic material directly onto organs or tissue. Unlike other bioprinting approaches, this system would only be minimally invasive, perhaps helping to avoid major surgeries or the removal of organs. It sounds like the future — at least in theory — but the research team warns it’s still five to seven years away from human testing.

The printer, dubbed F3DB, has a soft robotic arm that can assemble biomaterials with living cells onto damaged internal organs or tissues. Its snake-like flexible body would enter the body through the mouth or anus, with a pilot / surgeon guiding it toward the injured area using hand gestures. In addition, it has jets that can spray water onto the target area, and its printing nozzle can double as an electric scalpel. The team hopes its multifunctional approach could someday be an all-in-one tool (incising, cleaning and printing) for minimally invasive operations.

The F3DB’s robotic arm uses three soft-fabric-bellow actuators using a hydraulic system composed of “DC-motor-driven syringes that pump water to the actuators,” as summarized by IEEE Spectrum. Its arm and flexible printing head can each move in three degrees of freedom (DOFs), similar to desktop 3D printers. In addition, it includes a flexible miniature camera to let the operator view the task in real time.

The research team ran its first lab tests on the device using non-biomaterials: chocolate and liquid silicone. They later tested it on a pig’s kidney before finally moving onto biomaterials printed onto a glass surface in an artificial colon. “We saw the cells grow every day and increase by four times on day seven, the last day of the experiment,” said Thanh Nho Do, co-leader of the team and Senior Lecturer at UNSW’s Graduate School of Biomedical Engineering. “The results show the F3DB has strong potential to be developed into an all-in-one endoscopic tool for endoscopic submucosal dissection procedures.”

The team believes the device is brimming with potential, but further testing will be necessary to bring it into the real world. The next steps would include studying its use on animals and, eventually, humans; Do believes that’s about five to seven years away. But, according to Ibrahim Ozbolat, professor of engineering science and mechanics at Pennsylvania State University, “commercialization can only be a matter of time.”

At its annual health event, The Check Up, Google announced a slew of updates for Search, Fitbit and developers. On the Search front, the company says it will soon identify community health centers and make it clear whether those facilities have free or low-cost care options. It seems there will be a label that reads, "offers free or low-cost care based on individual circumstances."

In addition, Google says it has employed Duplex to call hundreds of thousands of US healthcare providers and verify their information. The conversational AI has also been used to check whether providers accept various state Medicaid plans.

After several pauses due to the COVID-19 pandemic, Medicaid will have a re-enrollment deadline this year. If folks in the US who are currently enrolled in the program fail to sign back up by March 31st, they'll lose their healthcare coverage. To help ensure people maintain their coverage, Google says it will make it easier for everyone to find re-enrollment information on Search.

Google

To assist those seeking help in a crisis, Google has teamed up with ThroughLine, which it says is the "largest verified network of mental health and crisis helplines around the world." As a result of the partnership, Google will expand the number of crisis helplines it displays at the top of Search results in more languages and countries for queries related to personal crisis situations, such as suicide and domestic violence.

Google

As for Fitbit, Google is opening up more of the Health Metrics Dashboard features available to users who don't have a subscription. The company says that, for instance, users will be able to view trends for metrics such as breathing rate, skin temperature and blood oxygen levels over longer periods of time.

Meanwhile, Google touched on some health-focused updates for developers. It discussed a suite of development tools called Open Health Stack, which it described as "open-source building blocks built on an interoperable data standard." In other words, Open Health Stack is designed to help developers build apps for healthcare workers to access key data and insights, such as population health data.

Google says the suite is based on Fast Healthcare Interoperability Standards and can be used to build apps that keep data secure for offline use in areas without internet connectivity or cell coverage. For instance, a developer in Kenya called Intellisoft Consulting is building a maternal health app designed to help community health volunteers and pregnant women in rural communities.

AI isn’t just good for writing term papers or clickbait financial explainers; it could help save lives in the medical field. At Google’s annual The Check Up healthcare event, it announced AI-related partnerships for ultrasound readings, medical language models and cancer treatments — areas where the technology could someday serve as a force for good.

Google sees AI as crucial in reading ultrasound devices in regions without enough trained specialists. Although the sensors are more accessible than ever, they require experts to conduct exams and interpret images. The company’s AI models could help simplify that process by identifying data like the early detection of breast cancer and gestational age in expectant mothers. To help make that a reality, the search giant is partnering with Kenya nonprofit Jacaranda Health to research AI-based ultrasound treatments for mothers and babies in government hospitals. “Through this partnership, we’ll conduct exploratory research to understand the current approach to ultrasound delivery in Kenya and explore how new AI tools can support point-of-care ultrasound for pregnant women,” said Google’s Health AI head Greg Corrado and Engineering VP Yossi Matias in a blog post today.

The company is also working with Chang Gung Memorial Hospital in Taiwan to research how AI can detect breast cancer via ultrasound as an alternative to mammograms, which have limited availability in lower-resource regions. Mammograms can also be less effective in populations with higher breast density. 

Evelyn Hockstein / reuters

In other areas, Google says its medical-focused large language model (LLM) has improved significantly. Med-PaLM 2, the company’s next-generation healthcare LLM, recently scored 85 percent on doctor-level medical exam questions — an 18 percent improvement from the previous version’s score. “This model not only answered multiple choice and open-ended questions accurately, but also provided rationale and evaluated its own responses,” said Corrado and Matias.

However, don’t expect a ChatGPT-like bot to replace your doctor anytime soon, as Google cautions the technology still isn’t ready for real-world work settings. For example, an evaluation on criteria like scientific factuality, precision, medical consensus, reasoning, bias and harm found “significant gaps” when answering medical questions. Corrado and Matias noted, “We look forward to working with researchers and the global medical community to close these gaps and understand how this technology can help improve health delivery.”

Google has also partnered with Mayo Clinic to explore AI’s part in planning radiotherapy for cancer treatment. The research focuses on reducing the tedious and time-consuming steps of the radiotherapy process — most notably, “contouring.” This technique requires clinicians to draw lines on CT scans to separate cancerous areas from nearby healthy tissues that the radiation could damage, a process that can take up to seven hours for one patient. The company says it will soon publish research from the three-year study while formalizing an agreement with Mayo Clinic to explore more radiotherapy-based research, AI models and commercial uses.

Finally, Google sees AI as helping with chest x-ray screening for tuberculosis. The company is partnering with an AI-based organization to make AI-powered TB screenings widely available in Sub-Saharan Africa. Its partners have committed to donating 100,000 free screenings to help detect tuberculosis early and provide early treatment to reduce its spread.

Cerebral, a telehealth startup that gained popularity during the early days of the pandemic, disclosed this week that it shared the personal data of more than 3.1 million US patients with social media companies and advertisers, including Google, Meta and TikTok. As first reported by TechCrunch (via The Verge), a recently uploaded notice on Cerebral’s website reveals the company had been using “pixels,” tracking scripts companies like Meta offer to third-party developers for advertising purposes, to collect user data since it began operating in October 2019.

Following a recent review of its software, Cerebral “determined that it had disclosed certain information that may be regulated as protected health information under [the Health Insurance Portability and Accountability Act].” Among the data Cerebral shared are names, phone numbers, birth dates and insurance information. In some instances, the company may have also exposed information it collected through the mental health self-assessment patients completed to schedule counseling appointments and access other services. According to Cerebral, it did not disclose social security numbers, bank information or credit card numbers.

After learning of the oversight, Cerebral says it “disabled, reconfigured, and/or removed” the tracking pixels that caused the data exposure. “In addition, we have enhanced our information security practices and technology vetting processes to further mitigate the risk of sharing such information in the future.” The US Department of Health and Human Services is investigating Cerebral. News of the data exposure comes after the Federal Trade Commission fined discount drug app GoodRx $1.5 million for sharing patient information with Meta and Google. Earlier this month, the agency announced a $7.8 million settlement with online counseling company BetterHelp and said it was seeking to ban the company from sharing health data for ad targeting.

Sensitive information for members of Congress and their staff and family members has been exposed in a data breach, according to House leaders. The FBI was able to purchase leaked information from health insurance marketplace DC Health Link on the dark web, House Speaker Kevin McCarthy and House Minority Leader Hakeem Jeffries wrote in a letter.

The data included the names of enrollees' spouses, dependent children, social security numbers and home addresses, according to the letter. "This breach significantly increase the risk that members, staff and their families will experience identity theft, financial crimes and physical threats — already an ongoing concern," it reads.

McCarthy and Jeffires said the FBI hadn't yet determined the size and scope of the breach, though they indicated that the impact on "House customers could be extraordinary." They noted that thousands of House members and employees from throughout the country have signed up for health insurance through DC Health Link since 2014.

“Fortunately, the individuals selling the information appear unaware of the high-level sensitivity of the confidential information in their possession, and its relation to Members of Congress,” the House leaders wrote. “This will certainly change as media reports more widely publicize the breach.”

“Currently, I do not know the size and scope of the breach, but have been informed by the Federal Bureau of Investigation (FBI) that account information and [personally identifiable information] of hundreds of Members and House staff were stolen,” Catherine L. Szpindor, the House of Representatives' chief administrative officer, wrote in a letter to colleagues. Reports suggest that the data also includes details on senators and their staff, but that information was seemingly limited to their names and those of family members.

DC Health Link operator DC Health Benefit Exchange Authority said it has opened an investigation. "We are in the process of notifying impacted customers and will provide identity and credit monitoring services," it told NBC News in a statement. The FBI has confirmed it's aware of the incident, while Capitol Police are assisting the agency with its investigation.

A member of a dark web forum reportedly claimed this week that they had data on 170,000 DC Health Link customers and were willing to sell the information. They later said the information had been sold.

“We’re gonna continue to work on this issue in a bipartisan way, get to the bottom of what happened, figure out the implications of what has occurred,” Jeffries said at a press conference on Thursday. “And also we’re gonna need some real reassurance as to guardrails that are put in place to prevent this type of data breach from ever happening again.”