When the FDA approved the NeuRx Diaphragm Pacing System to treat chronic hypoventilation in amyotrophic lateral sclerosis (ALS) patients in September 2011 under the Humanitarian Device Exemption (HDE), the agency required an extensive post-marketing study. Now Synapse Biomedical, which markets the neurostimulator breathing device, has reported interim data from that study that's a bit better than the approval data.
AirXpanders announced that the pivotal trial of its AeroForm Tissue Expander met its primary endpoint in women who seek a permanent breast implant following a mastectomy.
A device to cleanse circulating blood of pathogens and toxins under development at the Wyss Institute of Harvard University is ready for large animal testing--a precursor to advancing into a human proof-of-concept trial. This is a new iteration of the device that's designed to work with conventional antibiotic therapies in order to offer a more functional design for clinical use.
The federal Patient-Centered Outcomes Research Institute just approved $30 million in funding for comparative outcomes studies related to med tech, as part of the $65 million in research awards the agency doled out to 6 teams.
New medical devices for rectal cancer surgeries are helping patients forgo colostomies, shifting more individuals toward a new procedure that requires fewer external adjustments, according to medical experts.
A new fetal electrocardiogram (ECG) technology designed to be used along with conventional fetal heart rate monitoring contributes little benefit in reducing complications during childbirth, according to a study by the National Institutes of Health.
The feds recently said that device companies can subsidize copays in clinical trials, a move that was praised by food and drug attorneys at Hyman, Phelps & McNamara.
Helius Medical Technologies is set to begin a Phase III clinical trial with the U.S. Army Medical Research and Materiel Command for its Portable Neuromodulation Stimulator (PoNS), which is designed to treat balance disorder for patients with traumatic brain injury.
One of a handful of obesity devices aiming for the U.S. market has been sidelined. Australian company GI Dynamics has opted, after discussions with the FDA, to terminate its pivotal trial for its EndoBarrier due to safety concerns. The trial had already been placed on hold by the agency in March due to the incidence of hepatic abscess.
Edwards Lifesciences bumped up its transcatheter heart valve sales estimate for 2015 due to what it anticipates will be a strong U.S. launch for its third-generation TAVR device, Sapien 3. It was approved in June within a day of an FDA approval for a similar device from Medtronic, so the next quarter's earnings will start to tell the tale on how that U.S. next-gen TAVR competition will play out.