Integra gets 510(k) clearance for three spinal devices; Roche, Lonza enter MycoTOOL pact;

> Integra LifeSciences Holdings Corporation has received 510k clearance from the FDA for three new spinal intervertebral body fusion devices, continuing to build its momentum in the spine market. Integra release

> Roche and Lonza have entered into a co-exclusive distribution agreement for the commercialization of Roche's MycoTOOL mycoplasma PCR assays. Roche-Lonza release

> Seegene has launched its strategic push into personalized medicine by announcing a partnership with Samsung Medical Center to co-develop molecular diagnostics (MDx) for cancer. In this partnership Seegene will bring its molecular diagnostic technology leadership and Samsung Medical Center brings its clinical expertise and disease pathology to the development of new cancer MDx tests. Seegene-Samsung release

> Recently presented data showed that use of Tethys' PreDx Diabetes Risk Score to assess a patient's risk of developing Type 2 diabetes within five years results in more aggressive treatment and follow-up for diabetes prevention among patients whose test scores indicate high risk levels. Tethys release

> Medtronic confirms that Susan Alpert will be retiring from her post as the medical device giant's top regulatory official at the end of April. News

> Rochester Medical has now completed the previously announced purchase of Laprolan B.V., the former Medical Supplies Division and wholly owned subsidiary of Fornix BioSciences N.V. Under the terms of the agreement, the purchase is deemed retroactive to Jan. 1. Rochester Medical release

> Palomar Medical Technologies said it will establish a subsidiary in Germany to help the company gain international market share. The Burlington, MA-based medical device company makes the PaloVia Skin Renewing Laser, which was launched in December. Report

And Finally... The business model for medical device startups is said to be in jeopardy, and it's the topic du jour at conferences everywhere. At one recent conference, Beckie Robertson, a veteran investor and managing director with Menlo Park, CA-based Versant Ventures, presented slides about four new business models she sees as allowing entrepreneurs to find a way forward during this turbulent stretch for device companies. News

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