Cortechs.ai Gains FDA Clearance for NeuroQuant PET
COVINGTON, Ky., August 18, 2026 Cortechs.ai announced that its NeuroQuant® PET platform has received FDA 510(k) clearance (K261916) for...
FDA 510(k)
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ImpediMed Gains FDA Clearance for SOZO Sarcopenia Assessment
CARLSBAD, Calif., August 18, 2026 ImpediMed announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance...
Neuralytix Expands iD3 System for Spine Surgery
Fruita, Colorado, August 12, 2026 Neuralytix, LLC announced the full commercial availability of its iD3 System, an FDA 510(k)-cleared...
Co-Diagnostics Submits FDA 510(k) for PCR Respiratory Test
Salt Lake City, Utah, USA, August 7, 2026 Co-Diagnostics, Inc. has reached a major regulatory milestone by submitting a...
NIPRO Launches FDA-Cleared ELISIO-HX Dialyzer in U.S.
Osaka, Japan and Bridgewater, New Jersey, August 4, 2026 NIPRO CORPORATION, through its U.S.-based subsidiary NIPRO Medical Corporation, has...
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Intelligent Bio Solutions Advances FDA 510(k) Drug Screening Study
New York, August 3, 2026 Intelligent Bio Solutions Inc. (INBS) announced the completion of an Interference Study for its...
NIPRO Wins FDA Clearance for ELISIO-HX Expanded HD Dialyzer
OSAKA, Japan, July 30, 2026 NIPRO CORPORATION has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its...
VB Spine Receives FDA Clearance for Expanded Vitoss Indications
NEW YORK, July 29, 2026 VB Spine LLC announced that the U.S. Food and Drug Administration (FDA) has granted...
Elevation Spine Secures FDA Clearance for Saber-C AVIA
MONTEREY, Calif., July 29, 2026 Elevation Spine has received U.S. Food and Drug Administration (FDA) 510(k) Clearance for Saber-C®...
Masimo Earns FDA 510(k) for Pediatric Brain Monitoring
Irvine, Calif., July 27, 2026 Masimo, a Danaher company and global leader in patient monitoring technologies, has received U.S....
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