Logo Myocene MYOCENE kicks off the first FDA De Novo clearance of 2025 for its groundbreaking muscle fatigue monitoring device. LIèGE, ...
Lynx, Norlase’s pattern scanning laser indirect ophthalmoscope, commercially launched with both FDA 510(k) clearance and a CE ...
Allogene Therapeutics (ALLO) announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, ...
ClearPoint Neuro, Inc. CLPT, a global device, cell, and gene therapy-enabling company offering precise navigation to the ...
ClearPoint Neuro (CLPT) announced it has received 510 clearance for its ClearPoint Navigation Software Version 3.0. “As we prepare for the wave ...
The company states LYNX is the world’s first and only pattern scanning laser indirect ophthalmoscope and is battery-powered ...
News-Medical speaks with Jordi Labs’ about its recent achievements, alignment with FDA expectations, and strategic ...
(Nasdaq: IINN, IINNW) ("Inspira," or the "Company"), a leader in innovative medical technology, has announced the addition of new support features to the INSPIRA™ ART100, a system cleared by the U.S.
Insilico Medcine( "Insilico") , a clinical stage generative artificial intelligence (AI)-driven biotechnology company today announced the first patient has been dosed in the global multicenter Phase I ...
Nalu Expands MRI-Conditional Labeling for Peripheral Nerve Stimulation with FDA Clearance for Whole-Body MRI ...
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The FDA has granted clearance to the IND application of 225 Ac-SSO110, allowing for the commencement of a phase 1/2 trial titled SANTANA-225 in patients with SCLC or MCC. 1 SANTANA-225 is a global, ...