FDA clears Median Technologies’ lung nodule evaluation software
FDA approval for eyonis LCS was supported by data from Median’s RELIVE (NCT06751576) pivotal trial, which met its primary endpoint,...
FDA
FDA clears RevealDX’s AI lung nodule diagnostic
RevealAI-Lung is now reimbursable in the US under the Medicare Outpatient Prospective Payment System (OPPS) at a rate of $650....
FDA shares safety guidance for people considering microneedling
Being pricked by tiny needles may sound like a strange way to make your skin look better, but that's the...
FDA Proposes New Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones
Summary: The FDA has issued new draft guidance aimed at improving the accuracy and performance of pulse oximeters across different...
FDA Approves Bimzelx for Inflammatory Skin Disease
hidradenitis suppurativa © Lea - stock.adobe.comUCB announced today that the FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of moderate-to-severe...
FDA Sets Date For Resubmitted Dupixent in Inflammatory Skin Disease
The FDA has accepted the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric...
TytoCare Awarded FDA Clearance for AI Lung Sound Analysis –
What You Should Know: – TytoCare, a virtual care company enabling accessible, high-quality primary care from home, announced today that it...
FDA Sets Review Date for Tagrisso for Specific Lung Cancer Mutations
The FDA has granted priority review for AstraZeneca’s supplemental new drug application for Tagrisso (osimertinib) to treat adult patients with...
Brainomix swings FDA clearance for its lung imaging AI software
The FDA clearance follows after a phase II tralokinumab clinical trial published in the American Journal of Respiratory and Critical...
