Regulatory Approvals

inHEART has received CE certification under the new MDR for its inHEART models software suite

inHEART solution creates digital 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize cardiac ablation procedures Cambridge, MA...

Omeq Medical bags FDA approval for epidural guidance device

A medical device that aims to make administration of epidurals more reliable and safer has been cleared by the FDA, giving its developer Omeq...

Samsung gets FDA clearance for irregular heart rhythm notifications

It’s meant to enhance Samsung’s existing EKG features and arrives later this year with One UI 5 Watch. Samsung announced today that it received clearance from the...

Omeq Medical Receives FDA Regulatory Clearance for its Smart Device for Epidural Injections

 Omeq Medical Ltd. a portfolio company of The Trendlines Group Ltd., announced that it has received regulatory clearance from the United States Food and Drug...

bioMérieux receives US FDA CLIA-waiver for the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

bioMérieux, a world leader in the field of in vitro diagnostics, has received U.S. Food and Drug Administration (FDA) Clinical Laboratory Improvement Amendments (CLIA) waiver for...

Terumo Aortic announces FDA approval of dissection and transection indication expansion for the RelayPro stent graft system in the USA

Terumo Aortic announced that the US Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent graft device for the treatment of...

Formus Labs Hip Platform Receives FDA Clearance

Formus Labs today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Formus Hip as the first...

FDA clears Intuitive da Vinci surgical robot for prostatectomy

Intuitive Surgical(Nasdaq: ISRG)+ announced that the FDA cleared its da Vinci SP surgical robot for simple prostatectomy. The clearance, which includes prostatectomy as a representative procedure,...

FDA approves CT LUCIA 621P Monofocal IOL from Zeiss

Zeiss announced the US Food and Drug Administration (FDA) approval of CT LUCIA 621P Monofocal IOL.1 This aspheric, monofocal, single-piece C-loop IOL features optic (ZO)...
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