MASSDEVICE ON CALL — Oregon-based Biotronik said it won FDA approval for its Entovis pacemaker system with ProMRI technology, the latest in MRI-friendly pacing systems approved for the U.S.

The Entovis is the 1st FDA-approved MRI-friendly pacemaker with both single- and dual-chamber pacing options, Biotronik said. The company added that it’s the 1st worldwide to couple MRI-safe pacing with current-generation leads.

The FDA approval puts Biotronik on a short list, joining Minnesota medtech titan Medtronic (NYSE:MDT) in selling an MRI-friendly pacemaker approved by the FDA. Rival device makers Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ) are pursuing U.S. market approval for similar technologies.

It took Biotronik 16 months to get from its initial clinical study to expanded FDA approval for the Entovis system, according to a press release. Both the Entovis pacemaker and Setrox leads were already on the U.S. market, but lacked MRI-safe designation, Biotronik said.

 Israeli team grows bone from human fat cells
Israel-based Bonus BioGroup implanted its 1st patient with live bone grafts made from the patient’s own fat tissue.  
Read more

 Sustaining a donor liver
Researchers at Massachusetts General Hospital developed a system for transporting donor livers while keeping them perfused, allowing transport at room temperature.  
Read more

 Digital doc hand-wash stations get $1.7M
Illinois-based SwipeSense raised $1.7 million in funding for its Healthbox "smart" hand sanitizer dispensers and sensors.  
Read more

 Hip surgery and nerve damage may be connected by inflammation
Mayo Clinic researchers report that nerve damage from hip surgery may not be related to mechanical factors of the surgery as previously believed, but may instead be due to inflammatory neuropathies, in which the immune system attacks the nerves.
Read more