FDA expands indication for On-X Life's heart valve
April 3, 2015 by Mark Hollmer
On-X Life Technologies said it nailed down an expanded labeling claim from the FDA for its aortic mechanical heart valve.
The change relates to an international normalized ratio blood test, which measures the length of time needed for a patient’s blood to clot. Regulators expanded the label to allow the Texas company’s aortic heart valve to be managed, beginning 3 months after surgery, at an INR level of 1.5 to 2.0 – closer to the ratio of unmedicated patients. Read more
More CT scanner problems for Philips Healthcare
April 3, 2015 by Mark Hollmer
Royal Philips subsidiary Philips Healthcare is dealing with a Class II recall of several models of its CT scanners due to a software glitch.
It’s the latest problem for Philips Healthcare’s beleaguered CT scanner business, which last year was forced to shut down production at an Ohio plant after the FDA cited it for inadequate manufacturing controls. Read more
Augmenix wins FDA nod for SpaceOar prostate treatment
April 3, 2015 by Mark Hollmer
FDA clearance in hand, Augmenix is formulating U.S. commercial sales and insurance reimbursement plans for a medical gel designed to help protect the rectum during prostate cancer radiotherapy, CEP John Pedersen told MassDevice.com.
“We are rolling the technology out in a responsible way, focusing on physician training,” Pedersen said in a telephone interview. “Our goal is to train 20 to 30 centers this year in using the technology.” Read more
Biotronik launches Pantera Pro balloon catheter in Europe
April 2, 2015 by Brad Perriello
Biotronik said it’s launching the Pantera Pro balloon catheter, which won CE Mark approval in the European Union in January.
The German medical device giant said the new device is a complete re-design of its Pantera catheter that aims to improve access to the lesion site and ensure proper dilation. Read more
Baxter wins CE Mark for home dialysis device
April 2, 2015 by Brad Perriello
Baxter said that it won CE Mark approval in the European Union for its Homechoice Claria device, a designed for automated home peritoneal dialysis treatments.
The Claria device provides a secure, 2-way connection between the end-stage renal failure patient and the physician, Baxter said. Read more