Category: Cardiac Rhythm ManagementSyndicate content

FDA grants exemption for fetal micro-pacemaker

March 27, 2015 by Brad Perriello

The FDA grants a humanitarian device exemption for a micro-pacemaker designed to be implanted in a fetus.

FDA grants exemption for fetal micro-pacemaker

Comparative sizes of fetal
and adult pacemakers.
Click image to enlarge.

Researchers at Children's Hospital Los Angeles and the University of Southern California said the FDA granted a humanitarian device exemption for the fetal micro-pacemaker they designed.

CRM: Boston Scientific's gain is St. Jude Medical's loss

March 20, 2015 by Brad Perriello

The FDA's approval of Boston Scientific's Emblem S-ICD prompts Wells Fargo to downgrade St. Jude Medical, saying Boston Scientific is poised to take share in the cardiac rhythm management market.

CRM: Boston Scientific's gain is St. Jude Medical's loss

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FDA approves Biotronik's Eluna MRI-safe pacemaker

March 20, 2015 by Brad Perriello

Biotronik says it won pre-market approval from the FDA for its Eluna MRI-safe pacemaker.

FDA approves Biotronik's Eluna MRI-safe pacemaker

Biotronik said today that the FDA approved its ProMRI Eluna MRI-safe pacemaker, making it the only company with single- and dual-chamber MRI-safe pacemakers on the U.S. market.

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Boston Scientific wins CE Mark, FDA nod for smaller 'leadless' ICD

March 17, 2015 by Brad Perriello

Boston Scientific says it won CE Mark approval in the European Union and FDA approval for its newest 'leadless' implantable cardiac defibrillator, the Emblem S-ICD.

Boston Scientific wins CE Mark, FDA nod for smaller 'leadless' ICD

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Boston Scientific must pay pacemaker replacement surgery: EU court

March 5, 2015 by MassDevice

Europe's top court rules that Boston Scientific must cover the cost of replacing defective pacemakers.

Boston Scientific must pay pacemaker replacement surgery: EU court

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UPDATE: Cyberonics to buy Italy's Sorin for $1.4B

February 26, 2015 by MassDevice

Cyberonics agrees to an all-stock acquisition of Italian medical device maker Sorin that's worth about $1.4 billion.

Cyberonics to buy Italy's Sorin for $1.4B

Studies show Biotronik pacemakers safe for MRI use

February 18, 2015 by Val Kennedy

German cardiac device-maker Biotronik says 2 studies have confirmed its ProMRI pacemaker systems are safe to use with certain MRI procedures.

Biotronik settles kickbacks case for $5m

German cardiac device-maker Biotronik announced that 2 studies have confirmed its ProMRI pacemaker systems are safe to use with certain MRI procedures.

The studies tracked 226 patients with ProMRI Evia/Entovis SR-T and DR-T pacemaker systems for up to 1 month after they received MRI scans of either the head or lower lumbar region. Neither study reported any serious adverse events.

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