AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment
“The FDA’s clearance of our IND application to initiate clinical [...]
Janssen Submits Supplemental Biologics License Application to the U.S. Food and Drug Administration Seeking Approval of RYBREVANT® (amivantamab-vmjw) in Combination with Chemotherapy for the First-line Treatment of Patients with Locally Advanced or Metastatic EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer
“PAPILLON is the first randomized Phase 3 study in patients [...]
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, [...]