Regulatory Approvals

Creo Medical to launch UltraSlim device 18 months ahead of schedule

Creo Medical’s Speedboat UltraSlim to hit the market in early 2024 following guidance from EU regulator. UK-based company Creo Medical is planning the launch of...

Chordate Medical Secures EU Trademark Registration for Ozilia®

Chordate Medical has obtained the registration of the trademark Ozilia® in the EU from EUIPO (EU Intellectual Property Office) in trademark classes 9 and...

Positive six-month follow-up results for Recor’s renal denervation system

Recor Medical has followed up its US Food and Drug Administration (FDA) approval of its Paradise ultrasound renal denervation system earlier this year with...

FDA approves breast reconstruction trial using human ADM

The US Food and Drug Administration (FDA) has approved MTF Biologics’s trial using the FlexHD Pliable device in breast reconstruction after the agency granted...

Medtronic receives FDA approval for extravascular defibrillator to treat abnormal heart rhythms, sudden cardiac arrest

DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the Aurora EV-ICD™...

FDA Approves Protembis’ Pivotal IDE Study for ProtEmbo CEP System

AACHEN, Germany--(BUSINESS WIRE)--Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816)....

Cardio Flow receives US FDA clearance for FreedomFlow platform

Cardio Flow has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its FreedomFlow Orbital Atherectomy Peripheral Platform. The platform deploys a...

Praxis Medical Announces FDA Clearance of the EndoCore EBUS-TBNA Biopsy Device

Praxis Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the EndoCore EBUS-TBNA fine needle biopsy device. Endobronchial ultrasound with...

Heidelberg’s ANTERION platform gets US FDA approval

Ophthalmic imaging company Heidelberg Engineering has secured US Food and Drug Administration (FDA) clearance for its ANTERION platform. ANTERION is an all-in-one upgradeable platform to transform...
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