Medical Product Guide

HCTZ tablet for hypertension approved

Jim Marino — Mon, 13 Jul 2009 08:39:16 +0000

Glenmark Generics Inc and partner InvaGen has got the Abbreviated New Drug Application (ANDA) approval from the FDA for Fosinopril Sodium and Hydrochlorothiazide tablet to be used for the treatment of hypertension. Fosinopril Sodium and Hydrochlorothiazide(HCTZ) tablets are available in both 10mg/12.5mg and 20mg/12.5mg strengths. While Glenmark would exclusively market and distribute the product in the US, InvaGen would manufacture and supply the drug.

FDA asks asthma drug makers to add precaution on labels

Jim Marino — Mon, 06 Jul 2009 08:30:11 +0000

The FDA has asked the makers of Singulair, Accolate, Zyflo and Zyflo CR drugs to include the precaution regarding the reported changes in behavior and mood on their label. All these drugs are used to treat asthma and are leukotriene inhibitors, which affect the leukotriene pathway involved in the body’s response to inflammatory stimuli.

Parkinson’s May Improve Through Brain Device

Jim Marino — Mon, 06 Jul 2009 08:01:39 +0000

A new study published in The Journal of the American Medical Association shows that deep brain stimulation may show better improvements in disability and quality of life, as compared to other state-of-the-art treatments for patients with advanced Parkinson’s disease. However, there were also more serious side effects in patients who got deep brain stimulation. Deep brain stimulation requires the surgical implantation of electrodes and a device in the brain in order to electrically stimulate certain brain regions.

Journal shows possible tie between depression and bone metabolism

Melissa Chang — Mon, 19 Jan 2009 23:27:26 +0000

A study in the current issue of the European Journal Psychotherapy and Psychosomatics reveals that the association between psychiatric illness, in particular depression, and osteoporosis has been the subject of a growing body of research yielding various findings, although most identify some effect on bone.

In addition to medication-related processes and/or modifiable lifestyle factors associated with mood disturbances, endocrine and immune alteration secondary to depression may play a pathogenetic role in bone metabolism.

Additional longitudinal studies, with the advantage of temporal sequencing, remain to be conducted, as well as research into potential mechanisms surrounding the association. Nevertheless, the current findings are of clinical relevance, given the health burden of both depression and osteoporosis.

Check out the full article in ScienceDaily.com.

Beckman Coulter Announces FDA Clearance Of UniCel(R) DxH 800

Jim Marino — Fri, 02 Jan 2009 08:06:10 +0000

Beckman Coulter, Inc. ushers in a new era of cellular analysis with the release of the UniCel(R) DxH 800 Coulter(R) Cellular Analysis System. Capturing 29 individual measurements per cell analyzed, the system provides improved sensitivity and specificity, which means more reliable assessment of abnormal cell populations. Laboratories equipped with the system will be able to respond more quickly and accurately to physician demands, improving patient health and reducing the cost of care. The system’s all new physical design minimizes moving parts, increasing instrument reliability and technologist efficiency.

Sorin Group Announces The Japanese Approval And Market Release Of Defibrillation Lead: Isoline™

Jim Marino — Tue, 16 Dec 2008 10:50:23 +0000

Sorin Group has announced the Japanese approval and the market release of ISOLINETM1, its latest generation of defibrillation leads. Leads are insulated wires inserted through the vein as part of an implantable cardioverter defibrillator (ICD) or a pacemaker system. Connecting the device to the heart, the leads carry high voltage and electrical impulses from the implanted device to the heart when needed by the patient. ISOLINETM defibrillation leads have a multi-lumen structure with a silicone body and include an ETFE protective coating placed around the cables leading to the electrodes.

Merge Healthcare Releases Updated DICOM Toolkit

Jim Marino — Mon, 08 Dec 2008 10:10:36 +0000

Merge Healthcare has announced the release of MergeCOM-3(TM) Version 3.9, which adds the latest DICOM standard supplements to its industry-leading DICOM toolkit. Medical imaging software developers depend on MergeCOM-3 to jump start product innovation by providing much of the code needed to incorporate the DICOM standard. This standard is the basic “language” by which all medical imaging devices and systems communicate, and it is constantly improving to match the clinical needs of the industry. Version 3.9 contains support for important new standard supplements for nuclear medicine, pathology and ophthalmology.

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

Jim Marino — Fri, 28 Nov 2008 08:48:47 +0000

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

Jim Marino — Fri, 14 Nov 2008 15:11:56 +0000

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

Jim Marino — Thu, 06 Nov 2008 07:45:52 +0000

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.