FierceBiotech

UPDATED: FDA greenlights trial of Biotronik's MRI-safe pacemaker

Biotronik is looking to get the FDA's approval for a line of MRI-safe pacemakers--courtesy of Biotronik The FDA approved a clinical trial of Biotronik's proMRI pacemaker, a device designed to operate ...
Business Wire

FDA Approves BIOTRONIK Entovis Pacemaker System with ProMRI ® Technology

FDA approval comes only 16 months after the initial clinical study was launched, and five months after the approval of that study’s expansion to include full-body MRI scans. These studies are required ...
Medgadget

BIOTRONIK’s New Pacemakers and CRT-P’s with MRI AutoDetect Sensor

BIOTRONIK has unveiled its brand new Edora pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) following CE Mark approval in Europe. These devices feature BIOTRONIK’s ProMRI ...
TCTMD

FDA Approves Expansion of BIOTRONIK ProMRI® ICD Trial to Include Full-Body Scans and DX Technology

LAKE OSWEGO, Oregon, – BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved a significant expansion of its ...
KHON2

BIOTRONIK Receives FDA Approval For Next-Generation Family of Pacemakers

LAKE OSWEGO, Ore., July 6, 2023 /PRNewswire/ -- BIOTRONIK today announced U.S. Food and Drug Administration (FDA) approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization ...
Business Insider

You can have an MRI with a pacemaker, but you'll need to be cautious

Generally, pacemakers improve quality of life for individuals who have a condition causing bradycardia, or a slowed heart rate. However, because there is an electrical device implanted near your heart ...
manilatimes

BIOTRONIK Leaps Forward with Next‑Generation Leadless Pacing

International BIO-LivIQ Study Will Generate Evidence for Global LivIQ Leadless Pacemaker Approvals Far-Field Sensing and AV-Synchronous Pacing Performance Will be Validated by Real World Clinical Data ...
TCTMD

First US Patients Undergo Full-Body MRI Scans with Distinctive BIOTRONIK DX System Technology

LAKE OSWEGO, Oregon, US, – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that the first device patients to undergo full-body magnetic resonance imaging (MRI) ...
The Eagle

MRI Safe Pacemaker: Off Limits No More!

RALEIGH, NC ( Ivanhoe Newswire) -- They're magnetic mystery solvers helping doctors spot everything from brain aneurysms to tumors. But millions of people with pacemakers haven't been able to use ...
PharmiWeb

BIOTRONIK Leaps Forward with Next Generation Leadless Pacing

International BIO-LivIQ Study Will Generate Evidence for Global LivIQ Leadless Pacemaker Approvals Far-Field Sensing and AV-Synchronous Pacing Performance Will be Validated by Real World Clinical Data ...