Medical Devices News and Research

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Obama advisers suggest President might not oppose taxing some employer-sponsored health benefits

The Obama administration is "signaling to Congress" that President Obama "could support taxing some employee health benefits" to help offset the cost of health care reform, a move supported by "several influential lawmakers and many economists" but "opposed by union leaders and some businesses," the New York Times reports (Calmes/Pear, New York Times, 3/15).

16 Mar 2009

FDA approves new version of St. Jude Medical internet-based remote care system for implanted medical devices

St. Jude Medical, Inc. has announced U.S. Food and Drug Administration (FDA) approval of the newest version of the Merlin.net Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices.

16 Mar 2009

University of Florida doctors test targets for Parkinson surgery

Doctors may be able to tailor a specialized form of brain surgery to more closely match the needs of Parkinson patients, according to results from the first large-scale effort to compare the two current target areas of deep brain stimulation surgery, or DBS.

15 Mar 2009

New online tool to manage medical device reimbursement across Europe

Factory-CRO announced that it has launched a Web-based tool for medical device companies that wish to market and sell products in Europe.

12 Mar 2009

DSM obtains exclusive world-wide license for innovative drug delivery technology

Royal DSM N.V. has announced that DSM Biomedical obtained an exclusive world-wide license for a unique drug & biologic delivery system developed by MediVas LLC, a San Diego based biomedical company.

12 Mar 2009

10 million people in the U.S. suffer from lower-limb peripheral arterial disease

According to iData Research, an international medical device & dental market research firm, an estimated 10 million people in the U.S. suffer from lower-limb Peripheral Arterial Disease (PAD), with less than 20% of these diagnosed by a physician.

11 Mar 2009

FDA approves cardiac adhesion barrier for pediatric use

The U.S. Food and Drug Administration today announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery.

11 Mar 2009

Patented inventions double at University at Buffalo

An antibody with the potential to stop breast cancer in its path. A nanoparticle that can address a side effect of the treatment that hemophiliacs cannot live without. A "quantum dot" with the potential to treat cancer or harvest the power of the sun. An air purifier that kills the world's nastiest toxins.

5 Mar 2009

Federal health officials, prosecutors switch focus to physicians in illegal kickback cases

Federal health officials and prosecutors have begun to investigate physicians who receive money from drug and medical device makers for using their products, in an attempt to halt the illegal kickbacks, the New York Times reports.

4 Mar 2009

University at Buffalo designed ventilator can safely sedate ICU patients for less

A new, recently licensed medical device developed by University at Buffalo researchers would introduce into intensive care settings the powerful and effective method of anesthetizing patients that works so well in the operating room.

25 Feb 2009

CERAM offer medical device manufacturers key highlights to materials

CERAM, a global expert in medical device materials analysis, testing and consultancy, has published a white paper that highlights how critical a knowledge of materials and their characteristics is to the medical device manufacturer.

23 Feb 2009

FDA approves humanitarian device exemption for deep brain stimulator

The U.S. Food and Drug Administration has approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

20 Feb 2009

Recent reports regarding mercury and high fructose

ChemRisk, a leading scientific consulting firm, was asked by the Corn Refiners Association (CRA) to examine the recent publication by Institute for Agriculture and Trade Policy (IATP), "Not So Sweet: Missing Mercury and High Fructose Corn Syrup," and the Environmental Health journal publication "Mercury from chlor-alkali plants: measured concentrations in food product sugar," by Dufault et al, 2009, and to offer our comments and analysis.

2 Feb 2009

Electrical stimulation of the brain offers hope for Parkinson's sufferers

Electrical stimulation of the brain -- a treatment in which a pacemaker-like device sends pulses to electrodes implanted in the brain -- is riskier than drug therapy but may hold significant benefits for those with Parkinson's disease who no longer respond well to medication alone.

14 Jan 2009

Abbott to acquire Advanced Medical Optics

Abbott and Advanced Medical Optics (AMO) have announced a definitive agreement for Abbott to acquire AMO for $22 per share in cash, for a total transaction value of approximately $2.8 billion, inclusive of estimated net debt at the time of closing.

12 Jan 2009

Osteotech starts trial for DuraTech BioRegeneration Matrix

Osteotech, Inc. announced today that it has initiated a pivotal clinical trial for its DuraTech BioRegeneration Matrix.

7 Jan 2009

Next generation intermittent urinary catheters

Rochester Medical Corporation (NASDAQ:ROCM) today announced the introduction of Magic3(TM), its new line of intermittent urinary catheters.

18 Dec 2008

EPA should assess health risk of phthalates and other chemicals

The U.S. Environmental Protection Agency should examine whether combined exposures to chemicals known as phthalates could cause adverse health effects in humans, says a new report from the National Research Council. In addition, this analysis, called a cumulative risk assessment, should consider other chemicals that could potentially cause the same health effects as phthalates, instead of focusing on chemicals that are similar in structure, which is EPA's current practice.

18 Dec 2008

Abbott starts trial of 2.25 mm stent system

Abbott has announced the start of SPIRIT Small Vessel, a clinical trial evaluating a 2.25 mm size of the XIENCE V Everolimus Eluting Coronary Stent System.

17 Dec 2008

FDA Class 1 recall for two medical devices

The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.

15 Dec 2008