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Pfizer's new AI deal, chief equity officers, & an FDA clearance detail

 

STAT Health Tech

Good morning, Mario here with some fantastic stories from my health tech colleagues, starting with a look at what it will take to empower the executives who’ve been charged with advancing health equity. 

The rise of the chief equity officer

As the health care industry attempts to grapple with long-festering health disparities, companies like Teladoc Health and CVS Health have begun hiring chief health equity officers — executives whose jobs are to address the problem. But that's easier said than done. Companies still aren't clear on what the role should be, and some in these positions say they’re fighting for buy-in and resources from others at their organizations. Mohana has more on the challenges here.

Medical device ‘right to repair’ picks up steam

When your car breaks down, it’s relatively easy to get it fixed. But when life-saving equipment in hospitals needs service, it’s not so simple. Technicians are routinely denied access to service information and replacement parts, which is prompting a legislative push in many states that would compel medical device companies to be more cooperative. The companies, which stand to lose revenue under “right to repair” rules, are unsurprisingly opposed to the idea and cite patient safety as a primary concern. Read Jayne Williamson-Lee’s whole story on the issue here.

Pfizer’s new AI deal

Pfizer has made some interesting moves in health tech recently. The latest: a deal with Anumana to develop an artificial intelligence algorithm that can “enable the early suspicion of cardiac amyloidosis” from electrocardiograms. Anumana will be charged with validating the algorithm and seeking Food and Drug Administration clearance. The company, which has close ties to Mayo Clinic and has licensed three of its AI ECG algorithms for other heart conditions, also has deals with Janssen and Novartis. If you want to tell me what to make of all this, my inbox is open: mario.aguilar@statnews.com

Luminopia’s new-old FDA authorization

Luminopia in 2021 received FDA clearance for its for childhood lazy eye treatment that's delivered through a virtual reality headset. This fall it received an FDA clearance for… exactly the same thing.  So what’s the difference?

The clinical study supporting the company’s original clearance was done on a Samsung  headset, but as the company moved to launch the product to patients, it settled on a Pico headset that’s commonly used for commercial purposes. The new submission, excerpted above, demonstrates that the hardware specifications relevant to the treatment are the same between the devices.

Founder and CEO Scott Xiao told me this week that the company has established a reliable framework with FDA for how it will validate new headsets. “That's a really important piece for us because it gives us some flexibility to be able to qualify new headset models as they're released,” he said. “As we think about the future, if patients have their own VR headset, we want to be able to support them downloading the software.” 

As more companies seek clearances for products that run on commercial hardware, this will no doubt come up more and more.

Luminopia in November announced it had raised $5.7 million in additional funding and over the last month, has been conducting a limited rollout of the product with pediatric ophthalmologists to make sure all of the prescribing logistics work. He said the company has a waitlist of about 200 doctors who want to offer the treatment.

Personnel file

  • Virta Health appointed Manu Diwakar as chief financial officer. Previously Diwakar served as CFO at virtual musculoskeletal care company Kaia Health.

  • Neurological diagnostics company Altoida announced a slew of new hires, including Brooks Kenny who will be vice president of marketing.

What we’re reading

  • Death Sentence: An investigation into prisons’ refusal to treat hepatitis C, STAT

  • Has increased telehealth access during COVID-19 led to over-utilization of primary care?, npj Digital Medicine

  • Huge US study starts sharing gene findings with volunteers, Associated Press
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Thanks for reading! More next week,

Mario

Thursday, December 15, 2022

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