AMDI Wins FDA Approval for Sub-10-Minute Respiratory PCR Test
SANTA ANA, California, June 16, 2026 Autonomous Medical Devices Incorporated (AMDI) announced that the U.S. Food and Drug Administration...
FDA 510k Clearance
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Senzime Secures FDA Clearance for Enhanced TetraGraph
UPPSALA, Sweden, May 27, 2026 Senzime AB announced that the U.S. Food and Drug Administration has granted an additional...
Corvention Wins FDA Clearance for KardiaPSI Balloon
FLAGSTAFF, Ariz., May 11, 2026 Corvention announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance...
Sonorous Neurovascular Advances Care with BosCATH Approval
Lake Forest, California, USA – April 22, 2026 In a significant advancement for neurovascular intervention technology, Sonorous Neurovascular has...
Philips Boosts Cancer Imaging with Rembra FDA Clearance
Amsterdam, Netherlands – April 22, 2026 In a significant advancement for medical imaging technology, Philips has received U.S. FDA...
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Vapotherm Gains FDA Clearance for All Patient Circuit Device
Exeter, New Hampshire, USA, April 20, 2026 In a significant advancement in respiratory medical device innovation, Vapotherm, Inc. has...
Radical Catheter Gains FDA Clearance for 6F Device
LOS GATOS, Calif., April 13, 2026 Radical Catheter Technologies has received U.S. Food and Drug Administration (FDA) 510(k) clearance...
Protaryx Wins FDA 510(k) Clearance for Cardiac Device
BALTIMORE, MARYLAND, USA, April 13, 2026 Protaryx Medical has received U.S. FDA 510(k) clearance for its Transseptal Puncture Device,...
Allevion Medical Gains FDA 510(k) for Vantage System
BOCA RATON, Fla., April 1, 2026 Allevion Medical™ announced that the U.S. Food and Drug Administration (FDA) has granted...
GE HealthCare Wins FDA Nod for Photonova Spectra CT
CHICAGO, ILLINOIS, March 23, 2026 GE HealthCare has announced that the U.S. Food and Drug Administration (FDA) has granted...
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