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DTx evidence spotlight, Hims projects profit, & and FDA's digital leader on 'slowness'

November 9, 2023
Health Tech Correspondent

Good morning health tech readers! Heads up that next Thursday, November 16, I'll be moderating a panel for the Digital Medicine Society on the future of digital endpoints with leaders from Verily, AbbVie, and of course, DiMe. Hope you can join.

Reach me with tips and thoughts: mario.aguilar@statnews.com

Digital health

Digital Therapeutics evidence in the spotlight 

Screen Shot 2023-11-07 at 4.29.38 PMA glimpse at AppliedVR's data

This week, in Health Affairs, researchers published a sweeping analysis of the evidence underlying 20  Food and Drug Administration-cleared prescription digital therapeutics, and found it wanting. My colleague Deborah Balthazar writes that in particular, the authors found that most studies lacked information about the race and ethnicity of trial participants, excluded older participants, and often required the participants to be proficient in English. Read the full story here.


As if on cue, AppliedVR, which makes an FDA-cleared virtual reality treatment for chronic lower back pain, this week announced data, published last month, from a randomized control trial with over 1,000 participants comparing its treatment to a sham VR experience. The study found that after eight weeks of treatment, people reported significant improvement from baseline on measures of pain. The publication is the first in a series the company is planning based on data from this study, which is an effort to show that the evidence submitted for clearance extrapolates to a demographically diverse population for a long period of time. CEO Matthew Stoudt told STAT that building a broad body of evidence is crucial to helping convince insurers and other payers that virtual reality treatment actually works and is cost effective.


Regulation

FDA digital leader reflects on "slowness"

During a panel at this week's Milken Institute Future of Health conference, Troy Tazbaz, the former Oracle executive who recently took over the reins at FDA's Digital Health Center of Excellence, talked a bit about how the agency is attempting to make headway on regulation on hot areas like artificial intelligence. Though he didn't say anything groundbreaking, I was amused at his musing on the stark difference between his job at FDA and his time in Silicon Valley.

"First of all, there is the entire industrial complex that moves the minute that you make a decision and then the decisions that you do make have potential consequences that are at a scale that I never understood until I started working in the federal government," he said, adding: "We're not trying to be slow at this, we're trying to be thoughtful at this and sometimes thoughtfulness comes with some slowness as well."


Health equity

FDA blasted for pulse oximeter response

Speaking of the FDA and slowness: My colleague Usha Lee McFarling reports that 25 state attorneys general have called on the regulator to pick up the pace on its efforts to address how well pulse oximeters work on people with darker skin.

In a Nov. 1 letter, the AGs note it has been a year since FDA convened a public meeting of experts to hear concerns about how fingertip devices for measuring blood oxygen are tested and labeled. The letter cited Usha's extensive reporting on disparities in the accuracy of the devices.

Draft guidance on the devices is on the agency's "A-list" for next year, and a spokesperson said the issue is "a high priority" but gave no timeline for an update.

Read more here.



Big tech

Amazon discounts One Medical memberships

File this under one the most obvious things that could happen:  Amazon Prime members will now be eligible for discounted membership at One Medical. When Amazon acquired the care provider last year for close to $4 billion, the health care world went wild with theories about the retail giant's grand plans and what it all meant. Turns out that an early move is an effort to boost sales at One Medical by enticing loyal Amazon customers. It's not that much different than offering cheaper produce to Prime members at Whole Foods. 

This announcement has already lead to more commentary. Arielle Trzcinski from Forrester was in my inbox almost immediately, saying that the "move enables Amazon to bring its healthcare options together to create a more seamless customer experience, which consumers are craving" and pointing out that "this announcement comes as flu and cold season is gearing up and many consumers are going through open enrollment, including seniors evaluating Medicare Advantage plan options."


Virtual care

Hims & Hers projects net profit

Screen Shot 2023-11-07 at 8.36.27 PM

Hims & Hers Health, which provides virtual care with a focus on providing people with access to a range of drugs and products for common health needs, reported strong third quarter results, suggesting that among the glut of companies  providing very similar services, Hims will emerge as one of the winners. On the company's earnings call, leaders expressed that they expect the company to post "positive net income" in the first half of 2024 — if not potentially by the end of this year. Hims has been reporting an adjusted profit but a net loss for the last couple of quarters. 

The company also announced MedMatch, a machine learning technology trained on the company's data that's designed to help its providers "identify the most optimal treatment for a particular person, from medication formulary to dosage, to form factor," CEO Andrew Dudum said on the company's earnings call. The hope is that the technology will inspire trust with consumers and help them get to the right treatment faster without trial and error. The service will be launched first on customers seeking mental health treatment. 


Lizzys device digest

FDA news from J&J and Recor

STAT's medical devices reporter Lizzy Lawrence sent a few dispatches of note:

  • The FDA approved a surgical system targeting high blood pressure, called renal denervation, from startup Recor Medical, the company announced Wednesday. The system, which is a FDA-designated breakthrough device, was subject to an FDA advisory panel in August along with Medtronic. The panel voted in favor of Recor's device, but against Medtronic's — it had more contentious data. Read more here.
  • Johnson & Johnson wants to start testing its general surgery robot in humans, and is asking the FDA for permission. The company announced its plans on Tuesday. The robot, called Otava, consists of four arms built into a surgical table. Successful clinical trials could make J&J a fierce competitor of Intuitive Surgical, which currently controls the surgical robot market with its Da Vinci products.

research

Is remote patient monitoring worth it?

Remote patient monitoring has the potential to improve chronic disease management — but with little clear evidence to drive best practices, experts have warned that using connected devices like blood pressure monitors on the wrong patients could drive up unnecessary spending. A new study in Annals of Internal Medicine starts to chip away at the problem of who the right RPM patients are. A national analysis of more than 100,000 hypertension patients on Medicare showed that most of the benefits of RPM, like more active medication management, came in the first four months of use. And the patients who benefited most were those who started with poor blood pressure control. Next up: Getting practices to align their use of the technology with those kinds of insights — and maybe reimbursement codes that don't incentivize indefinite use for everyone.

Read more from STAT's Katie Palmer here.


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What we're reading

  • Elon Musk's brain implant startup is ready to start surgery, Bloomberg
  • Experts talk detecting disease from voice biomarkers with AI, privacy concerns, STAT


Thanks for reading! More on Tuesday - Mario

Mario Aguilar covers how technology is transforming health care. He is based in New York.


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