The latest on breakthrough devices, crowdsourced monkeypox support, & VA’s stumble on digital divide

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A boom in breakthroughs

The Food and Drug Administration’s authorizations for innovative devices have significantly accelerated this year, green lighting 11 of its 54 authorized “breakthrough devices” — as many as in all of 2020. The FDA deems “breakthrough devices” as potentially able to offer “more effective” treatment or diagnosis for deadly and debilitating conditions. But until this year, relatively few of the nearly 700 products labeled as such have reached the market.


Recipients get the benefit of more interaction with the agency and expedited review, as well as perceived superiority. A previous STAT investigation found that the designation gave financial advantages to device makers, despite a lack of evidence that the products are improving outcomes.

Sanket Dhruva, a cardiologist and health policy researcher at the University of California, San Francisco, said the potential benefits to patients “still remains an open question. And it remains more of an open question because we’re seeing more breakthrough device designations, and now we’re seeing that percolate down to the devices coming to market.” Katie has more.


AI-guided pain care could work just as well as regular phone therapy

Cognitive behavioral therapy that adjusts chronic pain patients’ treatment using artificial isn’t inferior to standard, phone-based therapy — and it uses far less of therapists’ time, a new study in JAMA Internal Medicine finds. 

The randomized study offered 10 weeks of therapy to 278 chronic back pain patients within the Veterans Affairs Department’s health system. The ones in the AI group also got daily automated calls about their pain progress; the system then analyzed their answers and then either recommended a 45- or 15- minute call with a therapist or an individualized voice message. The comparison group received 45 minute weekly phone calls with therapists. Researchers concluded that the AI-guided treatment wasn’t worse for pain patients than traditional phone-therapy, suggesting that it could help a limited number of therapists serve more patients safely, they wrote.

Crowdsourcing monkeypox support

Public health outreach to groups at risk for monkey pox — including men who have sex with men and nonbinary trans people — has been inconsistent, and resources like vaccines are still sparse. So some queer communities are turning to each other, and tapping into Instagram and Twitter for support and critical information about the virus.

“Because we oftentimes are not prioritized for our health by government organizations, we have to take charge ourselves,” Kyle Planck, a Ph.D. candidate in pharmacology at Cornell studying infectious diseases, told STAT. Planck had monkey pox earlier this summer and, according to his Twitter bio, has become an “unintentional monkeypox microinfluencer.”

People are circulating Google documents with crucial information and crowdsourcing on social media. Jennifer Barnes-Balenciaga, a co-investigator at RESPND-MI, a group of queer researchers who host weekly community forums on monkeypox, says social media helps spread the information as equitably as possible, especially for Black people in New York who initially didn’t have equal access to vaccines and trans people facing discrimination at vaccine clinics.

“It has been like wildfire to get information out, and people are so receptive,” she said. Our colleague Theresa Gaffney has the full story. 

Watchdog: VA’s digital divide plan falls short

The Veterans Health Administration’s efforts to reach patients who don’t have reliable Internet have fallen just short of their goals, despite distributing video-enabled devices to tens of thousands of patients, a new report from the VA inspector general’s office finds.

The VHA loaned devices to about 41,000 patients during the 2021 fiscal year — but only about 49% of them used them to do a video appointment with VA clinicians. The agency hadn’t set up clear oversight for the program, and there was no requirement that patients with devices schedule appointments.

The VA “could have made better use of approximately $14.5 million in program funds,” the report said.

Deals and partnerships

  • Mayo Clinic’s data platform accelerator, which gives AI startups access to its de-identified datasets, accepted its second cohort of companies. Data entry company AESOP Technology, infectious disease discovery startup Biotia, and autoimmune disease prediction company Predicta Med are among participants in the 20-week program.
  • Health information network Availity is buying Diameter Health, which organizes and enhances clinical data.
  • Intel Capital is joining remote monitoring company Biofourmis’ Series D round, bringing that round to $320 million.

Names in the news

  • Insurance tech company Clover Health’s co-founder Andrew Toy is slated to take over as CEO in 2023.S
  • Self funded employer health benefits company Collective Health added Mark Laret, who retired from his position as president and CEO of UCSF Health in December, to its board of directors.

What we’re reading

  • The federal government’s health IT office gives an update on its efforts to standardize addresses in patient data, ONC’s blog
  • Facebook gave police a 17-year old’s private chats about her abortion, Vice News
  • The NBA is using wearables to prevent injuries, FiveThirtyEight 
Source: STAT