Zavation Medical Products, LLC, receives FDA 510K Clearance for Varisync Anterior Cervical Plate and Spacer System As An Addition to its Cervical Spine Portfolio
Varisync, the most recent addition to the Zavation cervical spine [...]
MicroPort Navibot Receives 510(K) Clearance for SkyWalker™, the Company’s First Robot-Assisted Platform for Orthopedic ApplicationsI
The SkyWalker Total Knee System is the first robot-assisted platform [...]
Pulse Biosciences Receives FDA 510(k) Clearance of Expanded Energy Settings for use with the CellFX® System
A company spokesperson said, “We are pleased with how quickly [...]
FDA Approves First Systemic Treatment for Alopecia Areata
Alopecia areata, commonly referred to as just alopecia, is an [...]
Biobeat Remote Patient Monitoring Device and Platform: FDA Cleared for Additional Vital Signs
Biobeat notes their wireless wrist and chest monitoring devices, the [...]
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 [...]