Brainomix Targets US Expansion with the Launch of its Cutting-Edge Stroke AI Platform Following Series of FDA Clearances
The recent FDA clearances included Brainomix 360 e-CTP and Brainomix [...]
Telesair Receives FDA Clearance for Bonhawa High Flow Oxygen Therapy System
“The best in class Bonhawa system greatly improves patient care [...]
FDA Grants Fast Track Designation to 9MW3011
9MW3011 has been approved to clinical study by NMPA and [...]
MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil
“We are pleased to gain the QIDP and Fast Track [...]
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. [...]