Device Studies

Latest Headlines

Latest Headlines

JAMA study: Cochlear implants can cause pain during MRIs

Some patients with cochlear implants feel pain during an MRI that is strong enough to prevent them from completing the procedure, a recent study in the Journal of the American Medical Association shows.

Warburg Pincus' Silk Road gets pivotal stroke prevention data, FDA up next

Silk Road Medical has disclosed positive, pivotal data for its Enroute Transcarotid Neuroprotection System to reduce the risk of stroke. The device had the lowest stroke rate in any study of a carotid angioplasty and stenting device in a prospective trial, according to the company.

Gates Foundation backs Ebola trials for plasma-based and other treatments

Blood from Ebola patients who have survived infection has been used to treat patients actively fighting the virus. Now the Bill & Melinda Gates Foundation is backing efforts to test the efficacy of and scale up the production of convalescent plasma and other potential treatments in the field.

Study finds hand-held ultrasound device improves diagnosis of heart disease

Medical students who were trained to diagnose valvular heart disease using hand-held echocardiography technology performed better than students trained to diagnose the disease using only traditional methods, such as listening for heart murmurs with a stethoscope.

Brain tumor treatment device gets early trial halt for efficacy as a combo with chemo

The only FDA-approved, wearable cancer treatment device may expand its reach. A Phase III trial of Optune (NovoTTF-100A System) from Novocure was halted early due to statistically significant efficacy for the device in combination with chemotherapy to treat newly diagnosed glioblastoma patients.

Positive Phase II data for NeuroSigma comes after IPO postponement

NeuroSigma released top-line data for its noninvasive neuromodulation device to treat major depressive disorder. Next, the company plans a large, multicenter, double-blind clinical trial in this indication and may use that data to seek FDA approval.

Medtronic partners with DaVita, rolls out CRT meta-analysis data

Dialysis provider DaVita HealthCare Partners has partnered with Medtronic for a pilot program to study cardiac arrhythmias in end-stage renal disease patients receiving dialysis. It will use the tiny implantable cardiac monitor, Linq, which Medtronic launched early this year.

Aethlon to begin U.S. testing for its Ebola treatment device by year end

Aethlon Medical said it will, by the end of the year, begin U.S. clinical trials of its Hemopurifier device following news a German patient suffering from Ebola was declared free of the deadly virus despite suffering multiple organ failure.

The American Joint Replacement Registry hip and knee device database debuts

The American Joint Replacement Registry, the first national database keeping information on hip and knee replacements, released its inaugural report as part of a growing effort to track what have become almost common procedures in the U.S., but can result in expensive surgical repairs and costly legal action if they fail.

Power morcellation ban unlikely, but other FDA restrictions coming soon

The doctor who brought the cancer risks posed by power morcellation to the attention of the public and the FDA protested what he described as "imminent plans to use legal mechanisms to functionally institute a 'registry of outcomes' or a 'probationary period' in order to avoid banning power morcellators from the marketplace," in an email to Commissioner Hamburg, various U.S. senators, White House officials and others obtained by FierceMedicalDevices.