FDAnews Device Daily Bulletin

An analysis of data from a pivotal trial of Stryker’s Wingspan Stent that was aborted due to a high stroke rate failed to find a single “smoking gun” behind the adverse events and likely won’t lead to a reconsideration of the FDA’s recent use restrictions, one expert says.

Respironics’ Trilogy 100, 200 and 202 ventilators are being recalled because of defects in their power supply components.

When Theresa Hannigan was left paralyzed two years ago as a result of an autoimmune disease she had contracted while she was in the Army, doctors told her she would never walk again.

Qualcomm Foundation has awarded Scripps Health a three-year, $3.75 million grant to develop wireless medical devices, from tiny sensors in the blood to genetic testing at the local drugstore that could revolutionize health care.

Alere said it reached an agreement with U.S. health regulators on product specifications related to the manufacture of its diagnostic test for critical disease.

Smith & Nephew announced the launch of the TRIGEN Low-Profile Screw — the only truly “captured” head, low-profile screw on the market.

Solta Medical is eyeing rapid growth in Malaysia for its FDA-approved non-invasive fat reduction device, the Liposonix system.

Results from a cohort study published in Cardiology show that elderly women have a higher risk for complications and in-hospital mortality immediately after treatment with either drug-eluting stents or bare metal stents than elderly men.