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 [...]
Stryker’s Spine Guidance 5 Software featuring Copilot receives 510(k) clearance from FDA
Q Guidance System with Spine Guidance 5 Software featuring Copilot [...]
Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System in Urology
“This FDA clearance marks another milestone for Asensus Surgical and [...]
FDA Approves Roche’s Vabysmo Prefilled Syringe for 3 Leading Causes of Vision Loss
Vabysmo prefilled syringe is the first and only syringe prefilled [...]
Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA
Genio is a different approach to hypoglossal nerve stimulation (HGNS). [...]
FDA Approves PYZCHIVA ® (ustekinumab-ttwe), Samsung Bioepis’ Biosimilar to Stelara
“The FDA approval of PYZCHIVA as a biosimilar to Stelara [...]