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...
Zydus Lifesciences in Discussions to Acquire Majority Stake in Amplitude Surgical for €256.8M ($277.4M)
Zydus Lifesciences Limited announced on March 11, 2025, that it entered into an agreement to acquire a majority stake in Amplitude Surgical. Reports state that Zydus Lifesciences has a tender...
