Smith+Nephew Sets New Standard in Sports Medicine AI
LONDON, United Kingdom, July 29, 2026 Smith+Nephew has achieved a significant regulatory milestone after receiving U.S. Food and Drug...
FDA De Novo
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Celcuity Wins FDA Approval for REVTORPYK in Breast Cancer
MINNEAPOLIS, Minn., July 14, 2026 Celcuity Inc. has achieved a major regulatory milestone after the U.S. Food and Drug...
Autonomous Healthcare Creates New FDA Device Category with Syncron-E™
SANTA CLARA, Calif., July 14, 2026 Autonomous Healthcare has achieved a landmark regulatory milestone after the U.S. Food and...
Spectral AI Names Darcy Bajko Launch Leader
DALLAS, July 8, 2026 Spectral AI, Inc. announced the appointment of Darcy Bajko as Chief Commercial Officer, effective July...
Australia Expands Access to MDMA and Psilocybin Therapies Under New TGA Framework
VANCOUVER, British Columbia, May 29, 2026 Optimi Health Corp. has welcomed new recommendations issued by Australia’s Therapeutic Goods Administration...
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Leica Biosystems and CellCarta Advance AI-Driven Companion Diagnostics Worldwide
MONTREAL, Canada, May 29, 2026 Leica Biosystems, a global leader in anatomic and digital pathology solutions, and CellCarta, a...
Cardiosense Wins FDA De Novo for AI Heart Failure Technology
CHICAGO, Ill., May 29, 2026 Cardiosense has achieved a major regulatory milestone with the U.S. Food and Drug Administration...
TytoCare Wins FDA De Novo for AI ENT Diagnostics
NEW YORK, NY, April 27, 2026 TytoCare has achieved a major regulatory milestone with the U.S. Food and Drug...
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