FDA Emphasizes Use of Real-World Evidence for Medical Device Makers
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...
FDA to Drop 510(k) Requirements for Certain Low-Risk Devices, Lowering Barriers to Entry
On June 5, 2026, the U.S. Food and Drug Administration (FDA) issued updated guidance stating its intent to exempt certain unclassified medical devices from premarket 510(k) requirements, and that the FDA believes the identified device...
Johnson & Johnson to Acquire Atraverse Medical
Johnson & Johnson (J&J) reported on April 24, 2026, that it has entered into an agreement to acquire Atraverse Medical, a company in the cardiovascular medical device sector, for an undisclosed amount. The deal...
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