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...
Epineuron Receives 510(k) Clearance for Nerve Stimulator
Epineuron Technologies, a Canada-based clinical-stage nerve care company developing a bioelectronic therapy for the treatment of injured peripheral nerves, announced on May 12 that it has received 510(k) clearance of its Evala® Nerve Stimulator from the...
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