Regulatory

For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

The Institute of Medicine’s much-anticipated independent review of the FDA’s 510(k) clearance program for medical devices recommends that the entire program be scrapped in favor of a new protocol to ensure the devices are safe and effective. Medtronic officials and Sen. Scott Brown (R-Mass.) react.

Medtronic, Inc. today announced that it has settled a patent lawsuit it initiated against W.L. Gore & Associates.

Active Implants Corporation (AIC) today announced that it has received a CE Class III Certificate for its TriboFit® Hip System.

CryoLife, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CryoPatch(®) SG pulmonary human cardiac patch.

PEAK Surgical, Inc. today announced the launch of the PEAK® PlasmaBlade TnA (Tonsil and Adenoid) tissue dissection device following 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Onset Medical Corporation announced today the Company has received CE Mark approval to begin marketing the Company’s SoloPathTM Endovascular Access Catheter in the European Union.

Orthofix International N.V. announced that the Company has received CE Marking for its Advent™ Cervical Disc, allowing it to begin selling the new device in Europe.

Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the FS3 Minimally Invasive Spinal System.

CardioFocus, Inc. announced that it has received a CE Mark allowing the company to commence European marketing of the Endoscopic Ablation System (EAS) to treat patients with atrial fibrillation.

Abbott announced that it has received CE Mark for its next-generation XIENCE PRIME™ Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

CorNova Inc. announced that it has received CE mark approval for its Valecor Platinum Coronary Stent System.

Medtronic, Inc. today announced it has received CE Mark for the company’s second-generation pacemaker designed, tested, approved for use as labeled with MRI machines, the Advisa DR MRI™ SureScan™ pacing system.

Norian Corporation, Synthes, Inc. and four top Synthes executives have been indicted and face charges for their alleged involvement in conducting clinical trials of a medical device without the authorization of the US Food and Drug Administration.

St. Jude Medical, Inc. today announced U.S. Food and Drug Administration (FDA) approval of its Cool Point™ Irrigation Pump.

Spinal Restoration, Inc. announced today it has submitted the 6-month primary endpoint results from an ongoing 2-year IDE pilot study of the Biostat® System to the Food and Drug Administration.