Device Studies

Latest Headlines

Latest Headlines

Post-approval interim data on ALS neurostim device confirms survival benefit

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' tissue expander for breast reconstruction meets primary endpoint

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.

DARPA-backed Wyss Institute sepsis device being readied for human trials

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.

PCORI devotes $30M to outcome studies of orthopedic, bariatric and appendix surgery

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.

WSJ: New devices for rectal cancer surgery reduce need for colostomies

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.

NIH study sees little benefit to added fetal ECG monitoring during birth

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.

Feds come down in support of subsidizing copays in some clinical trials

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 enters clinical trial of its PoNS brain stimulation device to treat traumatic brain injury

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.

In a big week for obesity devices, GI Dynamics terminates U.S. pivotal obesity device trial

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 ups TAVR guidance on Sapien 3 launch, looks to expand indication in 2016

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.