Bipartisan letter questions FDA’s ‘narrow’ interpretation for priority review vouchersnews2024-10-28T17:38:59+00:00October 28th, 2024|Endpoints News|
Epitel Expands AI Portfolio With A Fourth FDA 510(k) Clearance for REMInews2024-10-21T14:27:17+00:00October 21st, 2024|Medical Device News Magazine|
CMR Surgical receives U.S. FDA Marketing Authorization for next-generation Versius Surgical Systemnews2024-10-16T14:22:20+00:00October 16th, 2024|Medical Device News Magazine|
Bracco Diagnostics and Subtle Medical Announce FDA Clearance of AiMIFY™ Software for Enhanced MRInews2024-10-16T13:42:50+00:00October 16th, 2024|Medical Device News Magazine|
Somite Therapeutics Announces FDA Orphan Drug and Rare Pediatric Disease Designations for SMT-M01 in Duchenne Muscular Dystrophynews2024-09-16T13:44:08+00:00September 16th, 2024|Medical Device News Magazine|
Withings Sleep Rx Receives FDA Clearance for the First Contactless Device to Aid in the Diagnosis of Sleep Apneanews2024-09-09T16:17:18+00:00September 9th, 2024|Medical Device News Magazine|
SKG1108 Receives FDA Orphan Drug Designation for Retinitis Pigmentosa | Reports Skyline Therapeuticsnews2024-09-03T11:18:45+00:00September 3rd, 2024|Medical Device News Magazine|
FDA Approves Illumina Cancer Biomarker Test with 2 Companion Diagnostics to Rapidly Match Patients to Targeted Therapiesnews2024-08-27T13:22:34+00:00August 27th, 2024|Medical Device News Magazine|
Qure.ai Launches FDA-cleared AI Solution for Advanced Lung Nodule Quantification on CT Scans at AABIP 2024news2024-08-22T14:03:16+00:00August 22nd, 2024|Medical Device News Magazine|
GrayMatters Health Expands Veteran and Civilian Access to FDA-Cleared Prism for PTSD™ Treatmentnews2024-08-20T13:15:03+00:00August 20th, 2024|Medical Device News Magazine|
