Bracco Diagnostics and Subtle Medical Announce FDA Clearance of AiMIFY™ Software for Enhanced MRI
This groundbreaking software, exclusively from Bracco Diagnostics and Subtle Medical, [...]
Somite Therapeutics Announces FDA Orphan Drug and Rare Pediatric Disease Designations for SMT-M01 in Duchenne Muscular Dystrophy
“Receiving both Orphan Drug and Rare Pediatric Disease Designations for [...]
Withings Sleep Rx Receives FDA Clearance for the First Contactless Device to Aid in the Diagnosis of Sleep Apnea
“We’re thrilled to bring Sleep Rx to the U.S. market,” [...]
SKG1108 Receives FDA Orphan Drug Designation for Retinitis Pigmentosa | Reports Skyline Therapeutics
SKG1108 is a recombinant adeno-associated virus (rAAV) vector with innovative [...]
FDA Approves Illumina Cancer Biomarker Test with 2 Companion Diagnostics to Rapidly Match Patients to Targeted Therapies
“FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics [...]
Qure.ai Launches FDA-cleared AI Solution for Advanced Lung Nodule Quantification on CT Scans at AABIP 2024
Qure.ai reports the new AI solution is now available to [...]
Guard Medical Announces FDA 510(k) Clearance for Additional Large Sizes of Its Novel NPseal® NPWT Surgical Dressing
“We’re excited to expand our portfolio with the NPseal 20 [...]
Pneuma Systems Infusion Technology Accepted by FDA’s Highly Selective Safer Technologies Program (STeP)
“This is a tremendous milestone,” says Pneuma Systems Founder and [...]
Labcorp Receives FDA De Novo Marketing Authorization for PGDx elio plasma focus Dx
“The launch of PGDx elio plasma focus Dx represents a [...]
FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma
“Potentially life-threatening cancers such as synovial sarcoma continue to have [...]