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FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Caranx Medical Announces FDA Submission of TAVIPILOT Soft: the World’s first AI Software for Real-time Intra-operative Guidance of Transcatheter Heart Valve Implantation
“This first release of our TAVIPILOT software marks an important step toward AI-augmented procedures. Our software is designed to be user-friendly, ensuring that cardiologists and surgeons can integrate it seamlessly into their usual practice. TAVIPILOT Soft allows clinicians to position a prosthetic valve easily and with high precision, ensuring that more patients could benefit from a high quality of care.” says Caranx Medical co-founder and CTO Pierre Berthet-Rayne.
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 of abenacianine to address existing deficits in lung cancer surgery by helping surgeons better visualize tumors in the lung during minimally invasive surgical procedures,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “We look forward to collaborating with the FDA to make abenacianine available to surgeons and their patients as quickly as possible.”
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 Vascular. “Initiation of this trial will begin in Q1 2025 and will be conducted at up to 60 global clinical sites with 264 subjects, and upon favorable conclusion will allow the company to complete and pursue a PMA market application for MAGNITUDE with the FDA.”
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 create a porous structure designed to mimic the structure of cancellous bone. This design aims to facilitate both initial and biological fixation, designed to accommodate patients' active lifestyles notes Exactech.
GT Metabolic Solutions Announces FDA Clearance of their GT Metabolic’s MagDI™ System
With this FDA clearance, the MagDI™ System is poised to launch a new frontier in healthcare as we continue to deliver on our visionary milestones for efficacy in magnetic surgery," said MedTech entrepreneur Thierry Thaure, CEO and co-founder of GT Metabolic.
Epitel Expands AI Portfolio With A Fourth FDA 510(k) Clearance for REMI
REMI Vigilenz AI For Bedside Notifications provides near real-time detection of potential electrographic seizures notes Epitel.
CMR Surgical receives U.S. FDA Marketing Authorization for next-generation Versius Surgical System
CMR Surgical notes the FDA marketing authorization of Versius is a significant milestone for CMR as Versius is the first multi-port, soft tissue general surgical Robotic Assisted Surgical Device (RASD) to successfully be authorized through FDA’s De Novo application process. Versius is a RASD intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments and is indicated in the U.S. for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.
Bracco Diagnostics and Subtle Medical Announce FDA Clearance of AiMIFY™ Software for Enhanced MRI
This groundbreaking software, exclusively from Bracco Diagnostics and Subtle Medical, is designed to significantly enhance MRI of the brain, particularly for detecting small and poorly enhanced lesions.
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 SMT-M01 is a significant milestone for Somite Therapeutics and, more importantly, for patients suffering from Duchenne muscular dystrophy," said Dr. Micha Breakstone, Founder and CEO of Somite Therapeutics. "These designations underscore the critical unmet need in DMD and the potential of our AI-driven approach to develop innovative cell therapies. We are committed to advancing SMT-M01 through clinical development as rapidly as possible to make a meaningful difference for DMD patients and their families."
