4.17.20
10 min. Read

Analysis: FDA’s new guidance for digital therapeutics

Issue 048.

Get E&O weekly. | Subscribe

Digital health research from Brian Dolan.

Welcome to E&O.

Last week's newsletter had a 59 percent open rate. Here's what's happening this week:

  • As part of the effort to make virtual care more accessible during the COVID--19 pandemic, the FDA posted a new enforcement guidance focused on digital health devices for the treatment of psychiatric disorders. Given how many DTx companies are focused on behavioral health, this move by the FDA has a lot of companies re-examining their go-to-market timeline. I pushed back the MSK report a few days as I've been on the phone with readers non-stop trying to getting my head around this guidance. Read more on the FDA's in today's top story below...
  • Decisions Resources Group has a worthwhile report out on payers' perspectives around digital therapeutics that is based on responses from 157 P&T committee members at

Paying Subscribers Only

It's a good one, too.
This digital health research is for paying Exits & Outcomes subscribers only. Subscribe now to read this article, get the weekly newsletter, and receive unrestricted access to past and future research from the Exits & Outcomes archives. Smash the link above or below to subscribe yourself -- or head over to our pricing page to subscribe your team or your whole company!
×

Full access to E&O's research and newsletters.

Get the subscribers-only newsletters + research reports + databases
Help me get ahead. $200/year

Prescription Digital Therapeutics

All Newsletters
    196 articles
  • First
  • Previous
    • 1 of 20
  • Next
  • Last
Facebook’s RCT for AI bot Zenny. More trials
1.26.24
7 min. Read
FDA de novo for Google smartphone thermometer.
1.05.24
6 min. Read
PDT-to-virtual-clinic trend continues. HCPCS tweaks.
12.15.23
8 min. Read
Mahana Tinnitus. New CPT hopefuls. Better cuts salaries
12.01.23
6 min. Read
CMS weighs HCPCS for Natural Cycles, Leva, and Tyto. Plus: Akili Q3 results.
11.16.23
8 min. Read
metaMe Health seeks buyer by year-end. CMS offers up digital therapeutics nothingburger
11.06.23
6 min. Read
PDT Pipeline changes. Kinsa shuts down. Trials
10.27.23
5 min. Read
CPT decisions. Trials: Big Health, Mahana and more
10.20.23
6 min. Read
Akili CEO steps down. Aetna rolls back some virtual care coverage
10.06.23
5 min. Read
Biogen cuts digital, MedRhythms, Apple. Pfizer on PDTs.
9.29.23
6 min. Read
  • First
  • Previous
    • 1 of 20
  • Next
  • Last