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Legal, Clinical & Regulatory

FDA 510(k) Recap: 9 First Clearances and Line Extensions

This month’s recap highlights devices of interest that received first clearances from companies new on our radar, like Augmedics, Avanti Orthopaedics, NanoOrtho, Nebula Surgical and Sonex Health, and the latest devices from Integra, Think Surgical, ExsoMed and Pantheon Spinal.

ISO 14971 Update Recognized by FDA, Aligned with EU MDR on Risk Management

The medical device risk management standard was updated to better align with changes in medical device regulations around the world. The standard emphasizes postmarket surveillance, is recognized by FDA and aligns with EU MDR requirements. 

Silver Bullet Therapeutics Gains CE Mark for OrthoFuzIon Bone Screw

An expanded CE Mark positions the company to improve patient care in the EU, and potentially disrupt the established commercial trauma market.