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Wireless Glucose Sensor In Development, UK

Jim Marino — Wed, 04 Aug 2010 05:04:19 +0000

Researchers in the UK have developed an implantable sensor that measures blood glucose levels continuously and transmits the information wirelessly. The sensor, however, has so far only been tested in pigs. The small, round device is being touted as having the potential to overhaul the way people with diabetes control their condition. The sealed unit has a pair of sensors and the researchers claim it could be implanted in a person’s torso with one sensor.

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Hotspur Technologies Receives FDA 510(k) Clearance For First Three Product Lines Based On its Unique Technology

Jim Marino — Wed, 04 Aug 2010 04:59:12 +0000

Hotspur Technologies, Inc. has announced that it has received FDA clearance for the first three commercial products in its portfolio. These products are based on Hotspur’s unique and groundbreaking technology that makes dialysis access interventional and peripheral vascular procedures that open blood vessels less expensive, more efficient, and less invasive for patients. These new Hotspur devices are focused on solving some of the key challenges resulting from two types of medical procedures for restoring bloodflow.

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Despite caution, device companies upbeat about 2010 prospects

Jim Marino — Mon, 30 Nov 2009 12:24:26 +0000

According to a survey conducted by Emergo Group Medical device and in vitro diagnostics manufacturers are increasingly optimistic about their prospects in 2010. The survey of 1,141 industry managers found that more than two of three believe the overall business environment will be better for the industry next year. A majority also said they expect to hire additional workers during 2010.

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.

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.

Olympus to launch Spiration’s IBV® Valve System

Jim Marino — Fri, 10 Oct 2008 05:47:24 +0000

Spiration, Inc. has made an announcement that its IBV® Valve System has been launched by Olympus in the European markets. The minimally invasive device is used for the treatment of various chronic lung problems. The system has already received the CE Mark for use in the treatment of serious diseases of the lung such as emphysema. Initially, the device will be presented to select physicians of Europe. The system may prove to be a boon for patients who can not or do not undergo surgical operation. Spiration® will continue with manufacturing while Olympus does the distribution.

Medtronic, Inc launches Discyphor Direct™ Catheter System

Jim Marino — Fri, 19 Sep 2008 13:52:06 +0000

Medtronic, Inc.’s Discyphor Direct™ Catheter System is now available in United States. Doctors use the second-generation catheter system to get more information on detecting the disc that causes discogenic low back pain. The system uses the company’s innovative Functional Anaesthetic Discography™ Procedure. Each disc is anesthetized individually for diagnosis of the disc that causes pain. Spine surgeons often use the procedure’s benefit in the form of diagnostic results to determine the best treatment for patients.

FDA classifies Physio Control’s AED correction as a Class I action

Jim Marino — Tue, 16 Sep 2008 05:32:50 +0000

The U.S. Food and Drug Administration has classified Physio-Control, Inc.’s medical device recall of 249 fully automatic LIFEPAK CR Plus automated external defibrillators (AEDs) as a Class I action. Some of these devices manufactured between May 2004 and April 2007 are configured incorrectly. The shock button can not be located as it is covered in the fully automated device. This may lead to a delay in delivery of therapy as a patient complained. Physio-Control has notified replacement devices at no charge to all the affected customers.

FDA Approves two ANDAs for for Dexamethasone Sodium Phosphate Injection

Jim Marino — Tue, 09 Sep 2008 14:30:18 +0000

The U.S. Food and Drug Administration has announced the approval of Akorn-Strides’ two ANDAs for Dexamethasone Sodium Phosphate Injection USP, 4 mg (base)/mL in 1mL, 5 mL, and 30 mL vials, and Dexamethasone Sodium Phosphate Injection USP, 10 mg (base)/mL in 10 mL vials. Akorn-Strides, LLC, a Joint Venture that was formed in 2005 by Akorn, Inc. and Strides Arcolab Limited aims to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting a number of ditherapeutic markets with a major focus on anti-infectives, analgesics and CNS drugs. The injection is used in the treatment of endocrine disorders, arthritis, blood disorders, dermatologic diseases, severe allergic reactions, eye diseases, certain cancers, gastrointestinal diseases and respiratory diseases.

Development in imaging device for congenital colon disease

Jim Marino — Thu, 14 Aug 2008 17:07:36 +0000

Researchers at Cedars-Sinai Medical Center are working on developing a spectral imaging system that could reduce the operating times for infants undergoing surgery for Hirschsprung’s disease, according to a mouse study published in the Journal of Biophotonics. Apart from the diagnostic capabilities, the system could provide an “optical biopsy,” enabling surgeons to determine the exact location of a needed intervention.

Photo by Mat Culpepper