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Electrophysiology & Arrhythmia

 

An FDA advisory panel recommended against the approval of the AngelMed Guardian system, an implantable cardiac monitor, designed to detect rapid changes in the heart’s electrical signal caused by a coronary artery occlusion.

 

 

Recent Headlines

FDA approves MR-conditional pacing system for patients with bradycardia

The FDA approved the ImageReady MR-conditional pacing system on April 25 to treat patients with bradycardia.

FDA approves the Micra miniature leadless pacing system

The FDA approved Medtronic’s Micra Transcatheter Pacing System (TPS) on April 6. The device is the first commercially available leadless intracardiac transcatheter pacing system in the U.S. The Micra is also the first transcatheter pacing system approved for 1.5 and 3 Tesla full-body MRI scans.

HRS announces quality improvement program for atrial fibrillation and stroke prevention

The Heart Rhythm Society (HRS) announced it would award up to $500,000 in grants for atrial fibrillation and stroke prevention research aimed at addressing National Quality Improvement priorities.

IBHRE announces award winners

The International Board of Rhythm Heart Examiners (IBRHE) announced on March 22 that three people had received awards for volunteering their time and making significant contributions to the organization.

FDA advisory panel recommends against approval of the AngelMed Guardian system

An FDA advisory panel recommended against the approval of the AngelMed Guardian system, an implantable cardiac monitor, designed to detect rapid changes in the heart’s electrical signal caused by a coronary artery occlusion.

Boston Scientific, Mayo Clinic collaborate on medical device development

Boston Scientific and the Mayo Clinic announced on March 16 that they would continue to share intellectual property to develop medical devices that address unmet clinical needs in fields such as interventional cardiology, heart rhythm management, endoscopy, neuromodulation, urology and pelvic health.

The ICD Impasse: Medically Right But Legally Wrong

A disconnect between best care and what Medicare is willing to reimburse for it has put some electrophysiologists and their hospitals in a bind.

FDA approves Boston Scientific’s quadripolar leads

The FDA approved Boston Scientific’s Acuity X4 quadripolar left ventricular leads on Feb. 23.

DOJ reaches settlements with 51 hospitals for allegedly improperly implanting ICDs

The Department of Justice (DOJ) announced on Feb. 17 that it had reached settlements worth a total of more than $23 million with 51 hospitals in 15 states for allegedly improperly implanting implantable cardioverter defibrillators (ICDs) cardiac devices in Medicare patients. The claims were allegations, and the DOJ did not determine the hospitals were liable, according to a news release.

FDA approves St. Jude Medical’s pacing technology, leads and quartet test

The FDA approved St. Jude Medical’s MultiPoint pacing technology, quadripolar pacing Quartet LV leads and programmer-based Auto VectSelect Quartet Test on Feb. 17.

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