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When will DTx go DTC like Ro, Hims? Pear early revenue predictions.

Issue 033. Get E&O weekly. | Subscribe |

Digital health research from Brian Dolan.

Welcome to E&O.

The last newsletter, Issue 032, had a 55 percent open rate. Here's what's happening this week (and the week or so before):

  • Over the holidays, the FDA published a fairly lengthy list of medical devices that will no longer be subject to 510(k) premarket notifications. While the move was mandated in 2016's 21st Century Cures Act, the list has some surprises: Glucose meters, for one. Stethoscopes, some body composition analyzers, and some computerized cognitive assessment tools also made the list. Read it here.
  • Missed this one: Early in December, Congresswoman Suzan DelBene of Washington state introduced a bill that would instruct Medicare to automatically cover medical devices designated as Breakthrough Devices by the FDA. Just a bill, but it would mean big things for companies like Cognoa,

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It's a good one, too.
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