Myra Vision Secures FDA Approval to Initiate US IDE Study in Glaucoma
The ADAPT study will evaluate the safety and effectiveness of the company’s Calibreye™ Titratable Glaucoma Therapy™ (TGT) Surgical System
August 12, 2025
FDA
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SurGenTec® Achieves Key Milestone with Expanded Indications for OsteoFlo® HydroFiber™
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.
July 22, 2025
DualityBio Reports: Next-Generation HER3 ADC DB-1310 Granted FDA Fast Track Designation
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.
July 22, 2025
UroMems Receives Clearance from the FDA and the French ANSM for Initiating Landmark Pivotal Clinical Study of UroActiveÒ Smart Implant to Treat Male Stress Urinary Incontinence
IDE approval in both countries follows strong feasibility clinical results in France.
July 17, 2025
Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
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.
July 2, 2025
Acera Surgical Broadens Reach of Restrata ® with New FDA Clearance for Soft Tissue Reinforcement
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.
June 25, 2025