Technology

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Ablation Catheters, Atrial Fibrillation, EP Lab, FlexAbility Ablation Catheter

Image courtesy of St. Jude Medical

St. Jude Medical Inc. announced U.S. Food and Drug Administration (FDA) approval of the FlexAbility Ablation Catheter, a new ablation technology...

Balloon catheters, Heart Valve repair, Cath Lab, Hybrid OR

Image courtesy of InterValve

Maquet Medical Systems USA announced an agreement to serve as the exclusive U.S. distributor of InterValve Inc.'s V8 Aortic Valvuloplasty Balloon...

Melody valve, FDA approval, PMA, pulonary valve

The Melody valve being deployed in the pulmonary valve position.

The U.S. Food and Drug Administration (FDA) has granted approval of Medtronic’s premarket approval...

MRI systems, MRI Accessories, RSNA 2015, FerrAlert Halo II Plus

Images courtesy of Kopp Development

Kopp Development Inc. released a new entryway system — FerrAlert Halo II Plus.

CVRx, Barostim neo Legacy System, pacemaker, hypertension, FDA, HDE

The U.S. Food and Drug Administration (FDA) has granted a humanitarian device exemption for the CVRx Inc. Barostim neo Legacy System.

Ambry Genetics, genetic testing, CardioNext, HCM, Rhythm

Ambry Genetics announces the launch of cardiovascular genetic testing panels for inherited cardiomyopathies and arrhythmias. These feature an...

Savaysa, Daiichi Sankyo, edoxaban, FDA, approval, NVAF, thromboembolism

Daiichi Sankyo Co. Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Savaysa (edoxaban) tablets, an oral, once-daily...

Bayer Healthcare, Gadavist, FDA, approval, pediatric patients, contrast media

Image courtesy of Bayer Healthcare

Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with magnetic...

Sorin Group, Memo 3-D ReChord, annuloplasty ring, mitral valve repair

Image courtesy of Sorin Group

Sorin Group announced U.S. Food and Drug Administration (FDA) clearance for Memo 3-D ReChord, a semi-rigid annuloplasty ring for mitral valve...

Medtronic, In.Pact, Admiral drug-coated balloon, DCB, drug-eluting balloon
The U.S. Food and Drug Administration (FDA) has cleared...
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