Intellectual Property Implications of the Medical Wearable and Wellness Device Revolution for Startups | MD+DI

The U.S. Food and Drug Administration (FDA) has increasingly emphasized the use of real-world evidence (RWE) to support regulatory decision-making for medical devices. As medical technologies evolve and data sources...

Protaryx Medical, a Maryland-based company dedicated to “minimally invasive left-heart interventional therapies,” announced that its Transseptal Puncture Device received 510(k) clearance from the FDA. Transseptal puncture is designed to enable access to...

On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced “a new pathway designed to expedite access to certain FDA-designated Class II...