Compression Works Receives Additional 510(k) Clearance from the FDA for the AAJT-S Life-Saving Junctional Tourniquet
The AAJT-S junctional tourniquet is designed to control non-compressible hemorrhages [...]
CardiacSense receives FDA Clearance for Medical Watch
Samuel Viskin MD, Senior Electrophysiologist at Tel Aviv Medical Center, [...]
Bresotec’s BresoDX1 for At-Home Sleep Apnea Testing Receives FDA 510(k) Clearance
Bresotec Medical founder and Chief Medical Officer, Dr. Douglas Bradley, [...]
New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials
The draft guidance is intended to assist industry, sponsors and [...]
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® [...]