Breaking News

Click's deal with Indivior, autism tech heats up, & FDA's new 510(k) draft

September 7, 2023
Health Tech Correspondent
Good morning health tech readers! We're in the middle of the STAT Future Summit, and this afternoon my colleague Katie Palmer will be interviewing not one but TWO chief medical officers who work for Amazon. Watch for news... and reach me if you know any: mario.aguilar@statnews.com

 digital therapeutics

Attacking the hole Pear left in the OUD treatment market

Click Therapeutics has a new deal with Indivior, maker of opioid addiction treatment Suboxone, to develop prescription apps to treat substance use disorders. The work will begin with a treatment for opioid use disorder.

According to the announcement, Click will receive license, development, and milestone payments, as well as the opportunity to expand the deal.

If this sounds familiar, that's because it's not a new idea. Pear Therapeutics in 2017 and 2018 received Food and Drug Administration clearance for reSET and reSET-O, its prescription digital therapeutics for the treatment of OUD and SUD. Pear went bankrupt this year after failing to build a business around its portfolio of digital treatments.

Click and Indivior also follow in the tracks of Orexo, which makes a Suboxone competitor called Zubsolv and has for several years been working on its own digital therapeutic treatments for OUD, problematic drinking, and depression. Though Orexo's OUD treatment, Modia, has not yet been cleared by FDA, the company's efforts have run into many of the same issues with adoption and reimbursement that Pear faced. 

So why is it different this time? The idea that PDT companies would do well to partner with drug developers is growing in popularity, and Click has been a leader at doing just that. Still missing: An example of a successful PDT that's used by lots of people and makes a profit.


Diagnostics

As autism tech picks up steam, are universal screening tools next?

Over the summer, a company called EarliTec Diagnostics received FDA clearance for its eye-tracking tech to help diagnose autism. The company just published the results of its pivotal trial in JAMA. EarliTech's tool, which works by using a specialized camera to track a child's eye movements while watching videos of social interactions, aims to measure "how children look at and learn from their surrounding environment," as the authors wrote in a feasibility study that was also just published.

EarliTec's EarliPoint System is not the first autism diagnostic aid to be cleared by FDA, but in an accompanying editorial, Duke's Geraldine Dawson suggests such tech might be useful as a tool for universal autism screening. Right now, EarliTec's device is only to be used as a diagnostic aid for children who've been referred to a specialist. With further studies of the technology in primary care and other settings, a similar tool could help reduce disparities in screening accuracy and support guidelines that recommend universal screening when children are 18 and 24 months old.


Big Tech

YouTube offers health creators money to support equity

YouTube on Wednesday announced two new initiatives it hopes will advance health equity.

First, it's creating a new "THE-IQ Creator Program" for health professionals who want to produce content "highlighting underrepresented communities." Creators can apply to the program, which includes workshops on video production and up to $10,000 to support making content, through October 5. 

The company will also begin working with selected health-related organizations, like Mass General Brigham and Elsevier's health education platform Osmosis, to pilot AI-powered dubbing services from a Google-owned tool called Aloud. They'll begin by dubbing existing content into Spanish and Portuguese, and the translations will be reviewed by clinicians.



Medical devices

The latest medical device news

  • The FDA released a draft of new best practices for selecting predicate devices for 510(k) submissions, the most common pathway used to pursue marketing authorization. The 510(k) pathways allows manufacturers of some devices to simply demonstrate they're substantially equivalent to already cleared products. While it's a boon for industry, researchers have pointed out potential shortcomings to the system. We'll be watching the docket closely to see how academic and industry audiences respond. 
  • Abbott is buying Bigfoot Medical, the maker of insulin management systems that turn glucose monitoring data into dosing recommendations. Abbott did not disclose how much it was paying for Bigfoot.The device giant isn't getting Bigfoot's insulin pumps, though — those were sold to Insulet in February for $25 million. 

More around STAT
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What we're reading

  • Inside the struggles at Calibrate, a new kind of weight-loss startup that's facing a mountain of patient complaints and refunds, Business Insider
  • AI in medicine—JAMA's focus on clinical outcomes, patient-centered care, quality, and equity,  JAMA
  • Robert Winn: Without 'high-touch' strategies, cancer's breakthroughs will increase disparities, 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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