April 19, 2007 — Following Tuesday’s seizing of all implantable medical devices from Shelhigh Inc., Union, NJ, by FDA investigators and U.S. marshals, the company has responded with denials to FDA claims that its manufacturing processes that may compromise the safety and effectiveness of the products, particularly their sterility. Shelhigh will challenge the decision in Federal Court (07 Civ 1769 WJM, New Jersey).

April 19, 2007 — Schering-Plough Corp. has announced plans to initiate two global Phase III large-scale clinical outcomes trials for its novel selective oral antiplatelet therapy, the thrombin receptor antagonist (TRA) SCH 530348.

The investigational compound inhibits the most potent stimulus of platelet activation, thrombin, which is a driver of the clotting process. This compound is being evaluated to determine whether it has the potential to provide clinical benefit without the additional bleeding liabilities often found in current therapies.


Genesis Health System has been dedicated to providing compassionate and quality health services from its inception over 12 years ago. Living up to that mission has required a commitment to information technology.

Among the challenges that face us in healthcare, retaining our best and brightest nurses is close to the top of the list. Nurse turnover is very expensive and seriously impacts the bottom line of every healthcare organization.

April 18, 2007 — Boston Scientific Corp. says the FDA has cleared the new Acuity steerable left ventricular lead device, for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure.

The product, which the company plans to launch in July, features a deflectable tip for precise placement of the lead even in difficult-to- access branch vessels on the left side of the heart, the company said in a statement.

April 18 — Cordis Corp. and ClearStream Technologies Group, plc, announced today the signing of a definitive distribution agreement whereby Cordis will market ClearStream's most advanced percutaneous transluminal angioplasty (PTA) balloon catheters under the brand names SLEEK and SAVVY LONG PTA Balloon Dilation Catheters.

The SLEEK and SAVVY LONG peripheral balloons will be marketed by the Cordis Endovascular division of Cordis Corp. The companies expect the products will be commercially available in countries outside the U.S. starting in the second quarter of 2007.

April 18, 2007 — Associated Press reports that on Tuesday U.S. marshals and FDA investigators began seizing heart valves and other implantable medical devices made from cow and pig tissue by a New Jersey company because of concerns about their sterility.

April 18, 2007 — Telzuit Medical Technologies Inc., Orlando, FL, has announced it has been successful in running its STATPATCH Holter Monitor software on various Windows-Mobile devices. The company is now testing these devices with the "STATPATCH" on human test subjects to ensure that it works for a 24-hour period and receives the data from the patch correctly and consistently.

April 17, 2007 — E-Z-EM Inc. has announced it has received 510(k) clearance from the FDA for its EmpowerMR injector system — the company's first product for the magnetic resonance (MR) imaging market.

EmpowerMR has the same easy-to-use interface and robust safety features as the company's other Empower injector line. EmpowerMR also employs several innovative features designed to cope with the problem of electrical interference in the magnetic field of the MR scanner.

April 17, 2007 — Boston Scientific Corp. said Monday that regulators have lifted a warning about quality-control problems at a Minnesota plant that makes defibrillators and pacemakers, enabling the company to resume seeking approval for new devices to correct abnormal heartbeats, the AP reported.

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