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This expansion of indications now includes use as a bone void filler for the treatment of tumors, cysts, trauma, and osteomyelitis. This landmark clearance represents a significant advancement in the capabilities of SurGenTec®’s cutting-edge technology and highlights the company’s commitment to enhancing patient care in orthopedic and spine surgery.
This designation is for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
IDE approval in both countries follows strong feasibility clinical results in France.
With this clearance, Maestro Systems can now have active Wi-Fi and 5G connectivity, enabling seamless data exchange with Maestro Insights—Moon’s cloud-based platform that gives surgical teams and administrators access to actionable insights from procedural data.
This new clearance broadens the clinical utility of the Restrata platform, now supporting soft tissue reinforcement applications in addition to its previously cleared indications for wound healing. This clearance applies to both Restrata Sheet and Restrata Meshed products.
This designation reflects Sanofi’s commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available.