Vergent Bioscience Receives FDA Fast Track Designation for Abenacianine for Injection (VGT-309) to Help Surgeons Visualize Tumors in the Lung During Surgery
“Receiving Fast Track designation from the FDA reinforces the potential [...]
FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDEÒ Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
Christopher M. Owens, President and Chief Executive Officer of R3 [...]
Exactech Reports the FDA Clearance of Truliant® Porous 3D Tibial Implant for Knee Replacement Surgery
The Truliant Porous Tibial Tray leverages additive manufacturing technology to [...]
GT Metabolic Solutions Announces FDA Clearance of their GT Metabolic’s MagDI™ System
With this FDA clearance, the MagDI System is poised to [...]
Epitel Expands AI Portfolio With A Fourth FDA 510(k) Clearance for REMI
REMI Vigilenz AI For Bedside Notifications provides near real-time detection [...]
CMR Surgical receives U.S. FDA Marketing Authorization for next-generation Versius Surgical System
CMR Surgical notes the FDA marketing authorization of Versius is [...]
Bracco Diagnostics and Subtle Medical Announce FDA Clearance of AiMIFY™ Software for Enhanced MRI
This groundbreaking software, exclusively from Bracco Diagnostics and Subtle Medical, [...]
Somite Therapeutics Announces FDA Orphan Drug and Rare Pediatric Disease Designations for SMT-M01 in Duchenne Muscular Dystrophy
“Receiving both Orphan Drug and Rare Pediatric Disease Designations for [...]
Withings Sleep Rx Receives FDA Clearance for the First Contactless Device to Aid in the Diagnosis of Sleep Apnea
“We’re thrilled to bring Sleep Rx to the U.S. market,” [...]
SKG1108 Receives FDA Orphan Drug Designation for Retinitis Pigmentosa | Reports Skyline Therapeutics
SKG1108 is a recombinant adeno-associated virus (rAAV) vector with innovative [...]