FDAnews Device Daily Bulletin

The European Commission is urging that medical devices containing nanomaterials be reclassified as Class III devices and subject to the “most severe conformity assessment,” due to risk of particles being released into the human body.

Six medtech groups from the Association of Southeast Asian Nations (ASEAN) have signed a memorandum of understanding affirming their commitment to advance the region’s device market and harmonize regulations as the TPMS Medical Device Industry group.

St. Jude Medical’s device to plug openings in the heart after a stroke failed to definitively prevent repeat incidents in patients younger than age 60 compared with non-surgical drug treatment, two studies found.

Mediomics, a company founded by Saint Louis University professor Dr. Yie-Hwa Chang, has been awarded a nearly $1 million contract under the Small Business Innovation Research program from the NIH.

Medtronic announced FDA 510(k) clearance and the first U.S. clinical use of its new Affinity Pixie Oxygenation System.

HeartSine Technologies, a medical device manufacturer based in the UK, announced that it would launch a global correction for its Samaritan 330/300P public access defibrillators.

Zimmer may not be as hard hit by the medical device tax as the company had previously estimated, executives said during a conference call with investors.

Medical devices aren’t the cause of fast-rising medical costs.