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Fdanewsdevicedailybulletin

Oct. 5, 2012

Vol. 9 No. 196

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SAMMPRIS Data Review Fails to Find ‘Smoking Gun’ Behind Strokes

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. Read More

Power Issues Lead to Ventilator Recall

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

Miracle Brace Lets Veteran Walk Again

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. Read More

Scripps Gets Boost on Wireless Devices

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. Read More

Alere Reaches Deal With FDA on Manufacture of Cardiac Test

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. Read More

Smith & Nephew Launches Industry’s Only Low-Profile Screw With Captured Head Technology

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

Solta Medical Eyes Rapid Growth for Fat Reduction Device in Malaysia

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

Stenting Outcomes Worse for Elderly Women Than Men

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. Read More