Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units
Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug Administration (FDA). This will be the first 510(k) cleared test of its kind available in the U.S. measuring ...
Healio1d
Lynx ophthalmoscope launches with FDA clearance, CE mark
Lynx, Norlase’s pattern scanning laser indirect ophthalmoscope, commercially launched with both FDA 510(k) clearance and a CE ...
Allogene announces FDA cleared IND application for study of ALLO-329
Allogene Therapeutics (ALLO) announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, ...
Hosted on MSN1d
CLPT Stock Gains on FDA Clearance for Navigation Software Version 3.0
ClearPoint Neuro, Inc. CLPT, a global device, cell, and gene therapy-enabling company offering precise navigation to the ...
ClearPoint Neuro announces FDA clearance for ‘Navigation Software Version 3.0’
ClearPoint Neuro (CLPT) announced it has received 510 clearance for its ClearPoint Navigation Software Version 3.0. “As we prepare for the wave ...
ophthalmologytimes2d
Norlase receives FDA 510(k) clearance and CE mark for LYNX pattern scanning laser indirect opthalmoscope
The company states LYNX is the world’s first and only pattern scanning laser indirect ophthalmoscope and is battery-powered ...
News Medical2d
Innovating for impact: Jordi Labs on aligning methodologies with FDA expectation
News-Medical speaks with Jordi Labs’ about its recent achievements, alignment with FDA expectations, and strategic ...
Medical technology firm's kidney test gets FDA approval
The Creve Coeur-based company is developing the use of proprietary fluorescent tracer agents as a noninvasive way to test ...