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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.

SANSA Home Sleep Apnea Test

Huxley Medical’s SANSA Home Sleep Apnea Test Gets FDA Nod

In a clinical trial involving 340 patients across seven institutions, SANSA obtained its initial FDA clearance in 2024, demonstrating its accuracy in comparison to the gold-standard polysomnography. This innovative test incorporates nine distinct physiological channels, such as oximetry, respiratory effort, sleep/wake staging, and a reference electrocardiogram (ECG), into a single patch worn on the chest. This integration allows for a comprehensive understanding of cardiopulmonary health and provides valuable insights.

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.”