Archive for November, 2008

Intel Announces its First Home Medical Device to Better Connect Clinicians With Patients

Intel Corporation has announced the Intel(R) Health Guide, a care management tool designed for healthcare professionals who treat patients with chronic conditions, for the UK. The Intel Health Guide represents Intel’s entry into a new category of personal health systems that go beyond the simple remote patient monitoring systems available today. The Intel Health Guide, a regulated device that carries the CE mark under the EU Medical Device Directive, is a comprehensive personal health system that combines an in-home patient device – the Intel Health Guide PHS6000 – as well as the Intel(R) Health Care Management Suite.

Boston Scientific gets approval from FDA for Apex™ PTCA Dilatation Catheter

Boston Scientific Corporation has announced that it has received approval from the U.S. Food and Drug Administration to market its Apex™ PTCA(1) Dilatation Catheter. The Apex Catheter is a high-performance pre-dilatation balloon catheter. It has been developed specifically to address physicians’ needs in treating the most challenging atherosclerotic lesions. The Apex Catheter is available for distribution in both Monorail® and Over-The-Wire (OTW) catheter platforms. It represents the next generation of dilatation catheter technology, utilizing a new Bi-Segment™ inner shaft for improved pushability and flexibility.

FDA approval for Salix Pharmaceuticals’ APRISO

The U.S. Food and Drug Administration has granted the marketing approval to Salix Pharmaceuticals’ APRISO (mesalamine) extended-release capsules 0.375 g. A locally-acting aminosalicylate, APRISO has been approved for the remission of ulcerative colitis (UC) in adults. APRISO is the only mesalamine product to receive an FDA approval as once-daily drug for the maintenance of remission of UC. Also, it is the first ever 5-ASA with Intellicor(TM) extended release delivery technology. The product will be available to physicians by early 2009.