VELMENI Secures FDA 510(k) for AI-Powered 3D CBCT Imaging
SUNNYVALE, Calif., July 23, 2026 VELMENI AI has received U.S. Food and Drug Administration (FDA) 510(k) clearance for VELMENI...
FDA 510(k)
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Intelligent Bio Solutions Completes FDA 510(k) Precision Testing Milestone
NEW YORK, July 21, 2026 Intelligent Bio Solutions Inc. announced the successful completion of precision testing, an important milestone...
Bluejay Completes Patient Enrollment in SYMON-II Trial
Acton, Massachusetts, USA | July 21, 2026 Bluejay Diagnostics has announced the successful completion of patient enrollment in its...
Philips Launches Alturion AI Ultrasound System for High-Volume Care
AMSTERDAM, Netherlands, July 8, 2026 Philips announced the launch of Alturion, a next-generation AI-powered ultrasound system designed to improve...
iHealthScreen Wins FDA 510(k) for iPredict-DR Software
RICHMOND HILL, N.Y., July 8, 2026 iHealthScreen, Inc. has announced that the U.S. Food and Drug Administration (FDA) has...
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Median Technologies Expands AI Lung Cancer Screening in Europe
SOPHIA ANTIPOLIS, France, July 2, 2026 Median Technologies has announced that its eyonis® LCS, an artificial intelligence (AI)-powered Software...
Co-Diagnostics Completes Validation for FDA 510(k) Submission
SALT LAKE CITY, Utah, July 1, 2026 Co-Diagnostics, Inc. has reached a significant regulatory milestone by completing the clinical...
RefleXion Submits FDA 510(k) for Anchor Point Tracking
HAYWARD, Calif., June 30, 2026 RefleXion Medical has announced the submission of a 510(k) premarket notification to the U.S....
STARMED Becomes First to Gain FDA Clearance for Thyroid RFA
LOS ANGELES, Calif., June 30, 2026 STARMED America has achieved a historic milestone in thyroid disease treatment after receiving...
Bioness Medical Secures FDA 510(k) Clearance for PoNS®
VALENCIA, Calif., June 29, 2026 Bioness Medical, Inc. has announced that the U.S. Food and Drug Administration (FDA) has...
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