Aidoc Secures Landmark FDA Clearance for First Foundation Model-Powered Clinical AI Solution of Its Kind
Aidoc, a global leader in clinical AI, has secured a defining FDA clearance for a CADt AI solution powered by a foundation ...
New World Medical Receives 510(k) Clearance for the VIA360 Surgical System, Further Advancing Innovation in Ophthalmic Surgery
VIA360 Surgical System with proprietary ActiveInject Technology delivers viscoelastic where you want it, when you want it, giving surgeons unmatched precision and control. RANCHO CUCAMONGA, CALIFORNIA ...
Business Wire12d
Hyperfine Reports on Growing Evidence for the Use of Swoop® System Images in Stroke Diagnosis Presented at the 2025 International Stroke Conference
About the Swoop® Portable MR Imaging® System The Swoop® Portable MR Imaging® system is U.S. Food and Drug Administration (FDA) cleared for ... The Hyperfine logo, Swoop, and Portable MR ...
Newronika Receives Investigational Device Exemption (IDE) from FDA to Initiate U.S. Clinical Trial of Adaptive DBS System
Newronika, the developer of groundbreaking adaptive deep brain stimulation technology, is proud to announce the receipt of an Investigational Device Exemption ...
Medindia8d
AliveDx announces US FDA 510(k) submission for MosaiQ AiPlex® Celiac Disease (CD) multiplex microarray
The MosaiQ AiPlex CD is designed to improve the  accuracy and speed of celiac disease diagnosis while simplifying laboratory workflows EYSINS, Switzerland , Feb.
Inspira Technologies Integrates New Oxygenation Indicator into AI-Powered HYLA Blood Sensor
Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) ("Inspira" or the "Company"), a pioneer in breakthrough life-support technology, today announced the integration of a next-generation oxygenation ...
The Associated Press on MSN14d
A timeline of last week's air disaster in Washington, the deadliest in the US since 2001
The rain clears. A Coast Guard cutter outfitted with a crane waits nearby as recovery team members slip into the chilly water ...
Hologic announces FDA clearance of Aptima SARS-CoV-2 assay
Hologic (HOLX) announced that the FDA has granted 510(k) clearance for the company’s Aptima SARS-CoV-2 assay, which was first granted Emergency ...
Targeted Genomics Receives FDA Clearance for First Direct-to-Consumer Celiac Disease Genetic Health Risk Test
Targeted Genomics LLC, a family owned genetic testing Company, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its Direct-to-Consumer GlutenID test. GlutenID ...
Wired5d
Here’s What the FDA Label on Your Personal Care Products Means
So, what do terms like “FDA-approved,” “FDA-cleared,” and “FDA-regulated” mean—and why do these labels matter? Understanding the differences will help you cut through the buzzwords ...