FDA Grants Clearance for UltraSight’s AI-Powered Cardiac Ultrasound Technology
New AI guidance software will allow more medical professionals to [...]
Invictus Announces FDA Clearance of Ground-Breaking Neoasis ® ANC Device
The Neoasis utilizes a proprietary, innovative active noise control (ANC) [...]
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New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials
The draft guidance is intended to assist industry, sponsors and [...]