SpinaFX Earns CE Mark for Triojection Spine System
TORONTO, July 16, 2026 SpinaFX Medical Inc. has achieved a significant regulatory milestone with the Medical Device Regulation (MDR)...
FDA Breakthrough Device
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Xeltis Surpasses 50% Enrollment in aXess US Trial
EINDHOVEN, The Netherlands, July 2, 2026 Xeltis announced that it has surpassed 50% patient enrollment in its U.S. pivotal...
Matter Bio Wins FDA IND Clearance for LM-LLO-TT Trial
SAN FRANCISCO, June 10, 2026 Matter Bio has announced that the U.S. Food and Drug Administration (FDA) has cleared...
SpinaFX Wins FDA IDE for Triojection Lumbar Disc Therapy
TORONTO, June 9, 2026 SpinaFX Medical has achieved a major regulatory milestone after receiving U.S. Food and Drug Administration...
Subtle Medical Gains FDA Clearance for SubtleHD PET
MENLO PARK, Calif., May 27, 2026 Subtle Medical, a leading developer of AI-powered medical imaging software, has announced that...
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TOBY Gains FDA Breakthrough Status for Alzheimer’s Test
AUSTIN, Texas, May 26, 2026 TOBY, Inc., a biotechnology company focused on non-invasive disease detection technologies, has announced that...
Cepheid Gains IVDR CE Mark for Xpert GI Panel
SUNNYVALE, Calif., May 13, 2026 Cepheid, a Danaher company, announced that it has received CE marking under the European...
Pfizer Wins EU Approval for HYMPAVZI in Hemophilia
NEW YORK, May 13, 2026 Pfizer has received European Commission approval for HYMPAVZI® (marstacimab) for the treatment of adults...
Exero Medical Highlights FDA Breakthrough xBar Study at ASCRS 2026
JERSEY CITY, N.J. and OR YEHUDA, Israel, May 11, 2026 Exero Medical has announced positive pivotal clinical study results...
PreludeDx Secures FDA Breakthrough for AidaBREAST Test
LAGUNA HILLS, CALIFORNIA, April 29, 2026 PreludeDx has announced that the U.S. Food and Drug Administration (FDA) has granted...
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