FDAnews Device Daily Bulletin

In observance of the Labor Day holiday, FDAnews Device Daily Bulletin will not be published Monday, Sept. 3. The next issue will be published Tuesday, Sept. 4.

Revising the role and transparency of notified bodies in the EU’s medical device approval process could be the centerpiece of the European Commission’s recast of the medical device directives (MDD).

Known for its relatively relaxed regulations on companion diagnostics (CDx), the European Medicines Agency (EMA) is not expected to provide guidance on the products until it has more experience in this area, an expert says.

Medical errors in the intensive care unit may kill as many as 40,500 patients per year, putting diagnostics on par with breast cancer for patient mortality, according to a new study.

Medtronic today announced new findings from the landmark IMPROVE HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) trial, which showed equivalent improvements in the care of heart failure patients across all races and ethnicities when evidence-based, performance improvement interventions were applied in outpatient settings.

Zynex, a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it received FDA 510(k) clearance on its InWave medical device.

By 2013, researchers at Bionic Vision Australia hope to start testing a bionic eye that would help people with macular degeneration and retinitis pigmentosa see large objects such as buildings or cars.

Sprint aims to build on the increasing use of personal mobile devices in health care by targeting its new bring-your-own-device (BYOD) management platform to hospitals and large physician practices.

With a relatively low market cap — when considering eventual potential — and with a technology that could drastically increase the effectiveness of modern day cancer treatments, OncoSec Medical Incorporated may be worth watching as a growth and catalyst play that may still be trading under the speculative radar.