Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
OK, here's what's happening this week in the world of pharma digital products and FDA-regulated digital health:
- Cognito Therapeutics shared results from its Phase II study and plans to move onto its pivotal study for its prescription digital therapeutic for Alzheimer's. Here's more about the PhII. (Remember: This one is a Breakthrough device and since it runs on its own hardware, it's likely a lay-up for the new MCIT reimbursement pathway.)
- Mahana Therapeutics received a CE mark for its IBS-focused, prescription digital therapeutic, Parallel.
- Empatica also received a CE mark for its wearable device, Aura, which certifies that it can detect and alert wearers to respiratory infections (including