Life Sciences Newsbriefs: Week Of June 20, 2011

CONTENTS:

Medical Devices Drugs & Biologics Food & Dietary Tobacco Medical Devices

Critics say analyses of 510(k) process aren't science-driven As the FDA considers changes to the 510(k) process for clearing medical devices, several analyses of the process have been released. Some critics say conclusions of such studies are being driven by bias rather than science. Ralph Hall, a med-tech executive and 510(k) process study author, said questions regarding the analyses are "a surrogate for the philosophical debate about the balance FDA must strike" and that the agency "has to balance safety versus access to new products and innovation."

Data indicate high rates of double CT scans in many U.S. hospitals Federal data indicate that hospitals performed 76,781 double chest scans on Medicare patients in 2008. Of 3,094 hospitals, 618 administered double scans on at least 10% of Medicare recipients while 94 did on at least 50% of the beneficiaries, according to federal data. Current industry guidelines say a double scan is appropriate only when diagnosing a tear in the wall of the aorta or examining arterial plaque buildup.

Chinese university to send medical tech to U. of Minnesota for evaluation The University of Minnesota's Carlson School of Management has signed a deal that will allow university students at Medical Industry Valuation Laboratory to evaluate medical technologies from the University of Shanghai for Science and Technology based on intellectual property and user valuation, among other criteria. Under the memorandum of agreement, the parties also plan to set up a joint training program that would enable Chinese specialists to gain knowledge about the U.S. regulatory process, among other activities.

NeuroMetrix signs marketing deal with Nipro NeuroMetrix has partnered with Nipro to sell its NC-stat blood test designed to diagnose diabetic peripheral neuropathy. The firms plan to unveil the point-of-care test at the American Diabetes Association's annual conference later this month.

Maquet pulls intra-aortic balloon pumps from market Maquet Cardiovascular is pulling from the market certain models of its intra-aortic balloon pumps after receiving reports that overheating may occur due to faulty fans, which could interrupt therapy and endanger the devices' users. The company has informed consumers about the problem and plans to offer replacements as part of the Class I recall.

AGA Medical files patent infringement lawsuits against Occlutech AGA Medical, a St. Jude Medical unit, has filed lawsuits in the U.K. and Germany against Occlutech alleging infringement of its patents for the Amplatzer occlusion device, which is used in transcatheter procedures designed to seal structural heart defects. Occlutech's occlusion devices for atrial septal defect and patent foramen ovale were cited in the lawsuits.

Analyst: J&J unit's move may be a boon to other stent makers Several device firms, including Boston Scientific and Abbott Laboratories, could see a bump in revenues after Johnson & Johnson's Cordis unit decision to exit the stent business, said Raj Denhoy, a Jefferies analyst. Denhoy said the market for implantable cardioverter defibrillators remains modest but is expected to stabilize later in 2011 as Medtronic and St. Jude Medical plan to launch new devices.

FDA approves Celgene's lymphoma drug Istodax for wider use Celgene obtained accelerated FDA approval for cancer drug Istodax to treat patients with peripheral T-cell lymphoma who have undergone prior treatment. Istodax was originally indicated for cutaneous T-cell lymphoma.

Covidien introduces management changes as new CEO takes over Starting July 1, several changes to the management structure of Covidien will take effect as Joe Almeida, incoming chief executive, takes over his post. Changes to the structure include the appointment of Bryan Hanson as president of the firm's surgical devices and energy-based businesses and Peter Wehrly as head of the respiratory and vascular therapies units.

Teleflex exits cargo systems unit to become a device-only firm Teleflex Chairman and CEO Benson Smith said the company has finalized its transformation from a "cyclical, diversified-industrial conglomerate" to a medical device firm after exiting its cargo systems business.

LabCorp extends deadline to acquire Orchid Cellmark Laboratory Corp. of America Holdings has extended to July 15 its offer to acquire Orchid Cellmark, which offers DNA testing services, for more than $85 million. LabCorp said it's still complying with the Federal Trade Commission's request for more data on the planned merger.

Orthofix International promotes COO to president and CEO Orthofix International has appointed Robert Vaters, its chief operating officer, to serve as president and chief executive. The company's move comes as Alan Milinazzo, its current president and CEO, is set to leave those posts in August.

Merit Medical plans to hold stock offering to raise money for M&A Merit Medical Systems said in a regulatory filing that it plans to hold a stock offering to pull in money to fund acquisitions and broaden manufacturing operations. In the filing, the device firm said it plans to repay debt worth about $25 million as part of a credit agreement.

Life Core Technologies names industry veteran as CEO Life Core Technologies has named Mike Burke, former CEO of TREK Diagnostic Systems, as its chief executive. Burke will spearhead a Series A financing round that aims to secure $3 million to enable the company to boost the commercialization of its medical device, which induces mild hypothermia to lessen the chances of damage to the brain of patients who have suffered a heart attack, brain injury or stroke.

Medline to market CAS Medical's vital signs monitoring systems CAS Medical Systems has signed a co-branding agreement that calls for Medline Industries to sell its Model 740 portable device used for monitoring patients' vital signs to hospitals and physician's offices. A spokeswoman for CAS Medical said the firm will be in charge of warranty repairs of the monitoring systems under the deal.

French agency seeks comments on current device maintenance rules Afssaps, the agency in charge of overseeing health care products in France, is seeking comments from companies and health care experts on the current medical device maintenance regulations to...