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FDA Clears New Device for Transseptal Heart Access

The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.

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Boston Scientific to Acquire Bolt Medical

Boston Scientific will acquire Bolt Medical, developer of an intravascular lithotripsy (IVL) platform for artery disease.

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Inspira Technologies Nabs FDA Clearance for Oxygenation System

Inspira Technologies has received FDA 510(k) class II clearance for its Inspira Art100 cardiopulmonary bypass system, which elevates patient oxygen levels quickly and may reduce the need for mechanical ventilation.

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FDA Clears New Device for Transseptal Heart Access

The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.

Cardiosave Hybrid and Rescue IABPs Recalled for Electrical Issues

Aug 11, 2023

Getinge recalled the Cardiosave Hybrid and Rescue IABPs because they may shut down unexpectedly due to electrical failure.

Acorai Heart Monitor Granted FDA Breakthrough Designation

Aug 10, 2023

Acorai, a startup medical device manufacturer, announced that the FDA has granted Breakthrough Device Designation for Acorai’s Heart Monitor.

FDA Grants J-Valve TF System Breakthrough Device Designation

Aug 1, 2023

Genesis MedTech announced that its J-Valve Transfemoral (TF) System has been granted Breakthrough Device designation by the FDA.

MagAssist Introduces BreathMo ECMO System

Jul 26, 2023

MagAssist introduced its ECMO system BreathMo, which uses maglev technology to reduce the risk of blood damage.

Cardiawave Granted New Patents for its Aortic Stenosis Tech in the US

Feb 13, 2023

Cardiawave SA, a deeptech medical device manufacturer that developed Valvosoft, a non-invasive medical device to treat aortic stenosis, announced the issuance of three new patents in the United States.