Accelus Receives U.S. FDA 510(k) Clearance for its FlareHawk TiHawk11 Interbody Fusion System
TiHawk11 is the latest addition to the company’s flagship FlareHawk® [...]
Access Vascular Receives FDA Clearance for HydroPICC® Biomaterial-Based Dual-Lumen Catheter
The single- and dual-lumen biomaterial catheters allow hospitals to reduce [...]
Aidoc Delivers the Most Comprehensive Neuroscience Package for AI-driven Coordination with New FDA 510(k) Clearance for Brain Aneurysm
Aidoc Co-found Elad Walach said, “We’re excited to include this [...]
FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs
Today, the U.S. Food and Drug Administration announced it is [...]
FDA Continues Co-sponsorship of MedCon Conference with AFDO/RAPS Healthcare Products Collaborative
FDA reports the event will bring together medical device regulators [...]
Fresenius Kabi Receives U.S. Food and Drug Administration 510(k) Clearance for Wireless Agilia® Connect Infusion System with Vigilant® Software Suite-Vigilant® Master Med Technology
Fresenius Kabi notes their wirelessly connected infusion pump system for [...]
SurGenTec Launches ION Screw, Smallest Posterior Spinal Fixation Implant, to Market After Receiving FDA Clearance
The patented ION implant is the smallest posterior fixation implant [...]
CardioMEMS HF System Receives FDA Approval to Support Patients Battling Earlier-Stage Heart Failure
“As the number one cause for hospitalizations in people age [...]
Medtronic Receives FDA Expanded Approval for Cardiac Cryoablation Catheters for Pediatric Treatment of a Common Heart Rhythm Condition
AVNRT is the most common form of supraventricular tachycardia (SVT), [...]
Eversense E3 CGM System for Up to 6 Months Receives FDA Approval Reports Senseonics
Physicians, nurse practitioners, and physician assistants interested in offering the [...]