AccurKardia’s AK-AVS Joins FDA TAP Program for AI Heart Screening
NEW YORK, June 16, 2026 AccurKardia announced that its AK-AVS™ aortic valve stenosis screening software has been accepted into...
FDA Breakthrough Device Designation
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Zepto Receives FDA Breakthrough Designation for FungiFlex Test
SAN DIEGO, Calif., June 3, 2026 Zepto Life Technology has achieved a significant regulatory milestone after receiving U.S. Food...
Gene Solutions Wins FDA Breakthrough Status for SPOT-MAS 10
SINGAPORE, May 28, 2026 Gene Solutions announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device...
Alpha Tau Completes Enrollment in Pivotal ReSTART cSCC Study
JERUSALEM, May 8, 2026 Alpha Tau Medical Ltd. announced the completion of patient enrollment in its ReSTART pivotal clinical...
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