Jan. 11, 2007 — The Society for Cardiovascular Angiography and Interventions (SCAI) today released a clinical alert advising physicians on practical steps for reducing the risk of a rare but serious complication associated with the use of drug-eluting stents. The document follows hearings held by the FDA’s Circulatory Systems Device Panel regarding the use of these devices.

Jan. 11, 2007 — First patients have been now been treated with the recently approved SurgiFrost XL, a new minimally invasive surgical probe for treating cardiac arrhythmias. CryoCath Technologies Inc. received FDA 510(k) clearance late in 2006, and the device also received CE mark approval during this same time period.

Jan 11, 2007 — FDA approval last week of Anthera’s Investigational New Drug (IND) application for its lead cardiovascular compound A-002 means the company will move forward with a multi-center phase 2 clinical trial (PLASMA — Phospholipase Levels And Serological Markers of Atherosclerosis). The study will examine the effect of A-002 on secretory phospholipase A2 (sPLA2) levels and other well established markers of inflammation and cardiovascular risk in patients with stable coronary artery disease due to underlying atherosclerosis.

January 9, 2007 - Konica Minolta Medical Imaging announced that it has been awarded contract positions with Amerinet, a group purchasing organization (GPO), for computed radiography, laser imagers and medical imaging films, effective from January 1, 2007 through December 31, 2009.

Jan. 10, 2007 – Eastman Kodak Company announced today that it has entered into an agreement to sell its Health Group to Onex Healthcare Holdings, Inc., a subsidiary of Onex Corporation, in a move that will sharpen Kodak’s strategic focus on consumer and professional imaging and the graphic communications industry.

Jan. 10, 2007 — Signalife Inc. says it has completed development of a one-of-a-kind cardiac vest that utilizes Signalife's patented signal amplification technology to allow for precise ECG monitoring of athletes and patients in harsh ambulatory environments.

Signalife will now proceed to submit the vest for accelerated FDA clearance and rapid movement to commercial availability.

Jan. 10, 2007 — A report is now available summarizing the findings from a workshop last October sponsored by Biophan Technologies Inc. and the FDA for the purpose of addressing safety issues surrounding MR and implantable medical devices.

Jan. 5, 2007 — MedicalCV, Inc., a cardiovascular surgery company, says it will amend its 510(k) submission for clearance of its SOLAR automated surgical ablation system for soft tissue ablation only following discussions with FDA and the company’s own counsel. Once clearance is obtained — which is expected imminently — Medical CV plan to market the system immediately.

Jan. 5, 2007 — An announcement from AstraZeneca is expected soon about the company’s experimental heart drug AGI-1067, the company’s partner AtheroGenics Inc. hopes to present results from a pivotal Phase III clinical trial to the American College of Cardiology (ACC) meeting in New Orleans.

Jan. 5, 2007 — A French court has ruled that Abbott Laboratories’ Xience V drug-eluting coronary stents infringe patents that are under exclusive worldwide license to Medtronic from evYsio Medical Devices ULC.

AFX News Limited reports that the Tribunal de Grande Instance de Paris ruled that Abbott's Xience V DES infringes evYsio's European Patent No. EP-B- 0 888 093 and has awarded evYsio the right to enjoin the importation, offering for sale, or sale of the Xience V stent in France.

Subscribe to
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now