FDA Archives - News Center

Pharaoh Neuro Receives FDA Breakthrough Device Designation for Neurapheresis CSF Management System

October 29, 2026 FDA

Pharaoh Neuro has received FDA Breakthrough Device Designation for its Neurapheresis Cerebrospinal Fluid (CSF) Management System, designed for the accelerated removal of blood and blood-breakdown products from the CSF of patients following aneurysmal subarachnoid hemorrhage.

Deep Reasoning AI Receives FDA 510(k) Clearance for NeuroDR Neurovascular CTA Software

October 28, 2026 AI, FDA

Deep Reasoning AI has received FDA 510(k) clearance for NeuroDR, fully automated AI software that converts head and neck CTA scans into 3D and curved planar views of the arteries supplying the brain, cleared 105 days after submission.

Teleflex Receives FDA Breakthrough Device Designation for Freesolve Resorbable Magnesium Scaffold

October 22, 2026 FDA

Teleflex has received FDA Breakthrough Device Designation for its Freesolve Resorbable Magnesium Scaffold for percutaneous coronary intervention, following a previous designation for the scaffold in below-the-knee applications and as the company advances the BIOMAG-III Pivotal Trial.

Edwards Lifesciences Receives FDA Approval for PASCAL Precision in Tricuspid Valve Repair

October 22, 2026 FDA

Edwards Lifesciences has received FDA approval for its PASCAL Precision system for tricuspid valve repair in patients with symptomatic severe tricuspid regurgitation, making Edwards the only company with a portfolio of repair and replacement transcatheter therapies for both the mitral and tricuspid valves in the United States.

Solventum Receives FDA Clearance for Combined Use of Restrata Matrix and V.A.C. Therapy

October 20, 2026 FDA

Solventum has received FDA 510(k) clearance for the combined use of its Restrata Synthetic Electrospun Fiber Matrix and V.A.C. Therapy, pairing a fully resorbable synthetic matrix with negative pressure wound therapy to streamline care and support active wound healing.

Haemonetics Receives FDA Approval for PerQseal Elite Vascular Closure System

October 20, 2026 FDA

Haemonetics has received FDA approval for its PerQseal Elite vascular closure system for large-bore arterial procedures, expanding its portfolio of large-bore closure devices for structural heart and endovascular procedures in the United States following its acquisition of Vivasure Medical in January 2026.

Stryker Receives FDA Clearance for Sonopet 3 Ultrasonic Tissue Removal Platform

October 14, 2026 FDA, Stryker

Stryker has received FDA 510(k) clearance for Sonopet 3, the latest evolution of its ultrasonic bone and soft tissue removal platform, featuring enhanced power, precision, and versatility along with new technologies including RISE and Pulse Control.

Centinel Spine Receives FDA Approval for Two-Level Use of prodisc C Nova

October 14, 2026 FDA, Spine

Centinel Spine has received FDA approval for two-level use of its prodisc C Nova cervical total disc replacement device, making it the third prodisc cervical device approved for both one- and two-level use and further expanding the company’s Match-the-Disc portfolio.

Vantis Vascular Receives FDA Clearance for 6F CrossFAST Microcatheter

October 14, 2026 FDA

Vantis Vascular has received FDA 510(k) clearance for a new 6 French model of its CrossFAST Integrated Microcatheter Advanced Delivery System, featuring a larger lumen to accommodate a broader range of interventional devices used in complex PCI procedures.

Okami Medical Receives FDA Expanded Indication for LOBO Vascular Occluder in Peripheral Veins

October 8, 2026 FDA

Okami Medical has received FDA expanded indication for its LOBO Vascular Occlusion System, extending its use into peripheral veins and broadening embolization options for patients with venous conditions such as pelvic venous disease and portal hypertension.