What the FDA just did for digital health

In an impressive move, the FDA made good on its plan to accelerate regulatory approvals for digital health through a new pilot program (and wrote a new action plan outlining future goals). What’s noteworthy? They plan to certify developers and firms, rather than products, enabling pre-certified companies to market and iterate on products without continuing to knock on the FDA’s door—or through a streamlined premarket review. Read more. Applications open tomorrow.

Headlines

The FDA Makes Good On Promise, Opens Applications For Pre-Certification Pilot
Tweet | MobiHealthNews

England’s Mental Health Experiment: No-Cost Talk Therapy
Tweet | The New York Times

The US Has Edited Its First Human Embryos
Tweet | MIT Technology Review

Timeline: How Apple Is Piecing Together Its Secret Healthcare Plan
Tweet | Healthcare IT News

Amazon's Secret Health Team Is Working On Medical Records, Virtual Doc Visits
Tweet | CNBC

Does Machine Learning Automate Moral Hazard and Error?
Tweet | Harvard

Recent Funding

• Women's health telemedicine company Maven closed an $11M Series A
• On-demand health transportation startup Circulation got a $10.5M boost
• Protein modeling and design toolkit maker Cyrus Biotechnology snagged $8M
• Hinge Health raised $8M to expand its remote monitoring program for chronic pain
• PhysIQ got $8M to use AI and wearables to monitor ambulatory patients