Medical Product Guide

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.

FDA expands indication for Hospira’s Precedex

Jim Marino — Fri, 31 Oct 2008 05:37:46 +0000

The U.S. Food and Drug Administration has expanded the indication for Hospira, Inc.’s Precedex(R) for use in non-intubated patients needing sedation before or during surgical procedures. Anesthesiologists, now, can administer Precedex safely for a growing number of out-patient applications like ophthalmic and orthopedic procedures.The broader indication is based on the results of two clinical trials involving 431 patients.

Spiration, Inc’s IBV® Valve System receives HDE approval from FDA

Jim Marino — Wed, 29 Oct 2008 05:04:09 +0000

The U.S. Food and Drug Administration has given Humanitarian Device Exemption (HDE) approval to Spiration, Inc. to use its IBV® Valve System for controlling air leaks which may become prolonged after procedures such as lung volume reduction surgery. This is the first approval from FDA for a bronchial valve implant for the lungs. Conventional treatments such as surgery can lead to complications and are expensive. This minimally invasive system is a safer and cheaper alternative.

Neuronetics’ Neurostar receives FDA approval

Jim Marino — Mon, 27 Oct 2008 05:00:13 +0000

The Food and Drug Administration (FDA) has given the approval to Neuronetics Inc.’s Neurostar [a transcranial magnetic stimulation (TMS) device] for use in the treatment of depression. The non-invasive tool stimulates the brain by transmitting magnetic pulses to the skull. The device will help the adult patients who have not benefited from anti-depressants. Also, this therapy has no risks as associated with electric shock therapy and surgically implanted electrodes.

FDA nod to InnerCool’s Rapid Blue System

Jim Marino — Mon, 27 Oct 2008 03:55:58 +0000

The U.S. Food and Drug Administration has given 510(k) clearance to Cardium Therapeutics’ operating unit InnerCool Therapies, Inc. for the commercialization of its RapidBlue(TM) System, a system to regulate body temperature. The closed loop catheter-based system of the device modulates body temperature by circulating saline within the catheter’s interior. Underwriters Laboratories found that the system met all the medical electrical safety standards including UL 471 Standard for commercial refrigerators, the first global certification for an endovascular thermal regulating device.