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FDA rejected Neuralink study pitch, Meta and ByteDance get into proteins, & Color layoffs

March 2, 2023
Medical Devices Reporter

Hi there. We have a jam-packed newsletter today: ByteDance and Meta build proteins with artificial intelligence, the DEA's proposal to restrict telehealth access to addiction treatment faces backlash, the medical device industry broadcasts their 2023 policy goals, and more. As always, hit me up at lizzy.lawrence@statnews.com 

artificial intelligence

Big Tech betting on AI protein designs

PROTEIN_SOCIAL-1600x900

TikTok teens? More like TikTok proteins. Big Tech is getting into the AI protein design game. Salesforce published a paper in Nature Biotech introducing a protein language model called ProGen that can create new protein sequences for specific functions. ByteDance, TikTok's parent company, recently introduced a method for adapting other protein language models to create new sequences, and Meta has been deep in protein research since 2019. 

It might seem unusual for tech companies to approach a classically biological problem — and to be so transparent with their research and discoveries. But protein research is a natural choice for tech companies eager to bolster their AI efforts, experts told STAT's Brittany Trang. "It's, in a sense, a low-hanging fruit. It's kind of an obvious problem for the tools that now exist," said Simona Cristea, the head of data science at Dana-Farber Cancer Institute's pancreatic cancer research center. Read more here.


telehealth

Critics say telehealth rule will worsen opioid crisis 

Doctors, public health experts, and even Democratic members of Congress are sounding the alarm on a new Biden administration proposal to restrict access to a key addiction treatment. 

The proposal would curtail access via telehealth to buprenorphine, a common, highly effective drug used to treat opioid use disorder. While doctors can currently give out both new buprenorphine prescriptions and refills after telemedicine visits, the new rule would require an in-person examination for patients who want to stay on the medication for longer than 30 days. 

"I don't want federal rules dictating to me when I have to cut somebody off a medication that, on the basis of the information available to me, is still appropriate for the patient," Brian Hurley, a public health official in Los Angeles, told STAT addiction reporter Lev Facher. Read more here.


Health tech

Color lays off employees working on Covid testing

According to LinkedIn and Twitter posts from impacted workers, health tech company Color laid off 300 employees on Wednesday. CEO Othman Laraki confirmed the layoffs on LinkedIn, saying the company decided to downsize its Covid testing operations given the end of the public health emergency. He wrote that the company will focus on testing and telehealth infrastructure for government programs, and prevention products for employers and large healthcare purchasers.

The company launched in 2015 with a focus on consumer genomics, but during 2021, pivoted to public health technology. The company began providing schools, nursing homes, cities, and medical schools with Covid testing systems. "What happened was initially we built a product, and in order to deliver it we built some infrastructure," Laraki told STAT at the time. "And then over time what we realized is, it's the infrastructure that's the product."

In 2021, when investor money was flowing, the company raised $167 million in a Series D funding round. In November of 2021, it was valued at $4.6 billion. But like other health tech startups, Color has been hit by the tough funding climate — not to mention the declining demand for testing as the pandemic wanes.


regulation

FDA rejected Neuralink's request for human research

The brain-computer interface company Neuralink has had a harder time starting trials in humans than founder Elon Musk has let on. Musk has said since 2019 that the company, which has tested its tech in monkeys, would soon start human studies. This morning, Reuters reported that the FDA rejected Neuralink's proposal for human studies last year, citing dozens of issues including the risk that the implant's wires could move elsewhere in the brain and questions about how the implant could be taken out without damaging the brain. In November, Musk said the company would secure the FDA's greenlight this spring — but employees told Reuters they're skeptical the issues can get fixed quickly.



medical devices

What the device industry wants from Congress in 2023

AdvaMed, the largest medical device trade association, released its 2023 policy priorities on Tuesday. The lobby put nine items on its political wishlist, but CEO Scott Whitaker told me that its most timely items are:

  • Pushing the Centers for Medicare and Medicaid Services to follow through on a proposed rule that would make it easier for breakthrough devices to get insurance coverage.
  • Getting Congress to pass the VALID Act, which would give the Food and Drug Administration more authority to regulate in-house diagnostics tests. The provision was omitted from last year's omnibus bill.
  • Urging the Environmental Protection Agency to allow the medical device industry to continue using ethylene oxide for sterilization in its anticipated rule proposal this year. The chemical is known to cause cancer at high levels of long-term exposure, but device makers say it is critical. 

"This is the industry's agenda," Greg Crist, chief advocacy officer at AdvaMed, told me. "It is a fulsome industry snapshot of what we think would improve the industry writ large."


covid-19

Covid surveillance's toll on essential workers

The pandemic normalized the use of tech-based surveillance, like infrared thermometers, on essential workers. A new report from the nonprofit Data & Society found that this tech didn't offer workers clear and accurate information that would help them protect their health, and sometimes even made their workplaces less safe. Researchers assessed the impact of Covid-19 surveillance on these mostly Black, Latino, and low-income workers — and found these practices compounded information gaps and added stress and extra labor for laborers already vulnerable to these factors before the pandemic. Read more from STAT's Ambar Castillo here.


funding

Industry ups and downs

  • Boston Scientific has filed a WARN notice to lay off 120 employees at a Houston facility. It plans to transfer the Texas operation to Minnesota.
  • Sleep care platform Better Night raised $33 million in a funding round led by New Spring, with participation from HCAP Partners and Hamilton Lane
  • Telehealth wellness company Hims & Hers reached record revenue levels in 2022, growing from $272 million a year ago to $527 million this year.
  • The Digital Medicine Society released a digital health regulation toolkit to help founders better understand which pathway their device falls under.

More around STAT
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What we're reading

  • This dental device was sold to fix patients' jaws. Lawsuits claim it wrecked their teeth, Kaiser Health News
  • Post-Roe, prosecutors can seek unprotected reproductive health data, Axios
  • CRISPR patent fight redux? A new battle is brewing among biotechs over next-gen gene-editing tools, STAT

Thanks for reading! More on Tuesday - Lizzy

Lizzy Lawrence is a medical devices reporter at STAT.


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