Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay runs on the fully [...]
Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® for Coagulation of Subcutaneous Soft Tissues Following Liposuction for Aesthetic Body Contouring
Charlie Goodwin, President and Chief Executive Officer of Apyx Medical. [...]
VySpine Announces FDA Clearance for UniVy OsteoVy-Ti Cervical IBF with NanoVy-HA
The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features VySpine’s NanoVy-HA [...]
Neuspera Medical Announces FDA Clearance of Its System for Peripheral Nerve Stimulation
The Neuspera system delivers peripheral nerve stimulation (PNS) through a [...]
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New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials
The draft guidance is intended to assist industry, sponsors and [...]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 [...]