Life Sciences Newsbriefs: Week of August 23, 2010

CONTENTS:

Medical Devices

Drugs & Biologics

Biotech

Food & Dietary

Medical Devices

Minn. lawmaker tackles concerns about proposed 510(k) changes Sen. Al Franken, D-Minn., on Friday held a conference with medical-device companies in Minnesota to discuss their views on the changes proposed by the FDA to the 510(k) process for clearing medical products. Franken is seeking a meeting with FDA Commissioner Margaret Hamburg in September to relay the industry's concerns about the changes in an effort to "continue to foster medical innovation and protect patient safety."

Confusion from identical medical tubes can harm patients Mix-ups of identical medical tubes have resulted in serious injuries and deaths in some hospitals, according to this New York Times article. Although some standards advocates and experts have pushed against the interchangeability of tubes intended for different functions, the FDA approval process and medical-device industry resistance have stalled actions to address the problem, the article adds.

Doctors face stricter policy on imaging self-referral As part of the health care reform law, doctors who own imaging equipment must disclose their ownership in writing whenever they refer Medicare patients for in-office imaging. The new rule, which is set to be effective next year, will also require doctors to furnish patients with a list of other nearby sites where they can undergo similar imaging services.

FDA clears Aesculap Implant's spinal fusion system The FDA has granted 510(k) clearance to Aesculap Implant Systems for its A-Fix, a device used in spinal fusion surgery. The product is intended for use in patients with degenerative disc disease whose spondylolisthesis is up to grade 1.

Hologic, Conceptus limit scope of patent infringement suit Hologic and Conceptus have agreed to limit their patent infringement lawsuit over their female sterilization systems by dropping all allegations of unfair competition from the case. In May 2009, Conceptus filed a lawsuit accusing Hologic of violating five patents for Conceptus' Essure system.

BD to get financial backing from Texas government The Texas Enterprise Fund is putting $1.56 million toward helping New Jersey-based Becton, Dickinson and Co. build a global professional services office in San Antonio. The state's investment in the medical-device firm will help generate almost 300 jobs and bring in capital investment of roughly $6.35 million, according to Texas Gov. Rick Perry's office.

BSD Medical's ablation tool gets FDA clearance BSD Medical said it received 510(k) clearance from the FDA for its MicroThermX Microwave Ablation System, which is used in soft tissue.

Biomet gets warning letter over preoperative surgical planning system Biomet has received a warning letter from the FDA saying the company's Signature Personalized Patient Care system, which is used for creating a preoperative plan for the implantation of another company product, the Vanguard knee replacement, does not have clearance or approval from the agency. Biomet said it responded to the agency's letter explaining its reason for believing the device "has been appropriately marketed under a 510(k) premarket clearance," and added that it plans to resolve the issue with the FDA.

Irish agency calls for effective traceability systems for devices The Irish Medicines Board has released an advisory recommending that medical-device makers, distributors and health care personnel ensure that their traceability systems for medical products used at homes, hospitals and other care settings are effective. The IMB issued the notice after finding that poor device-monitoring could affect the success of product recalls and other safety corrective measures.

German court rules on KCI, Smith & Nephew patent dispute A district court in Germany ruled that Smith & Nephew's Renasys canisters and foam dressings violate a European patent held by Kinetic Concepts for its negative pressure wound treatment. Meanwhile, the court found Smith & Nephew's Renasys GO negative-pressure wound therapy device does not violate KCI's patents.

FDA is seeking comment on device user-fee program The FDA will hold an open meeting on Sept. 14 to seek views and suggestions on how to develop its new medical device user-fee program as the authority for the current program is set to expire in September 2012. The agency will accept written feedback until Oct. 14.

FDA panel to review MELA's cancer detection tool in November An FDA panel will meet on Nov. 18 to review MELA Sciences' MelaFind, a device that can detect melanoma using a computer-regulated multi-spectral dermoscope. The panel was originally scheduled to meet this month for the evaluation of the product.

Report: Molecular-imaging device market to be worth $6.6B by 2014 The value of the molecular-imaging device market likely could rise to $6.6 billion by 2014, a report from Kalorama Information said. The report estimated that the market could see a continuance of the current 5.8% annual increase as the result of the rising demand for more precise diagnostic devices, as well as the growing use of the technology in drug discovery.

Mardil hopes to raise $6.5M in funding round for medical device Mardil said in a regulatory filing that it already has secured $1.5 million as part of a planned $6.5 million financing round. The Morrisville, N.C.-based company plans to use the money from its first funding round to further develop a less-invasive device designed to treat mitral valve regurgitation.

NContact Surgical gets additional $1M in debt financing Morrisville, N.C.-based nContact Surgical disclosed in a Securities and Exchange Commission filing that it raised $1 million in debt financing, bringing its total funding to $4 million. The company is the developer of a minimally invasive surgical tool used for treating atrial fibrillation.

CGIT hopes to help Mass. device firms enter Chinese market Crystal Global Information Technology has set up an office in Quincy, Mass., to help medical device firms in the state overcome regulatory and marketing obstacles of establishing operations in China. "Exports of U.S. medical devices to China are expected to double from $14 billion to $28 billion, so it made a lot of sense to focus the new U.S. office on this industry," said John Jarowski, one of the founders of CGIT.

Virtual colonoscopy can detect other types of cancers outside the colon A study involving 2,277 patients showed that the use of virtual colonoscopy resulted in the detection of suspicious lesions outside the colon in almost half of the patients. The finding included 240 medically significant lesions. The ability of virtual colonoscopy to spot cancers outside the colon suggests that it could be used as an alternative to traditional colonoscopy, the researchers said.

Arstasis plans to boost staff in preparation for product launch Arstasis plans to move its office to Redwood City, Calif., and increase its workforce fourfold as it prepares to launch its first product early next year. The company has developed a device that can be used in accessing femoral arteries during angiography.

Device makers set sights on wireless pacemakers Several medical device makers have expressed interest in developing wireless pacemakers to allay concerns about lead failures and the cost of surgery. Among the companies reportedly working on leadless...