• AgaMatrix (Salem, New Hampshire) has introduced its second blood glucose meter, the WaveSense Jazz. The blood glucose meter offers features including no coding and backlit digits for easy reading. The Jazz also has a number of other advanced features designed to help people with diabetes gain tighter control over their blood glucose levels. Glycemic variability is a tool often used to show how often blood sugar changes over a period of time and how intense these fluctuations are. Glycemic variability may also allow for an end-user and their health care professional to better analyze the effect of high and low readings over specific days, weeks or months. The Jazz, like the company’s first meter, the KeyNote, is also powered by WaveSense. WaveSense technology is a suite of technologies that enable high accuracy glucose monitoring products. WaveSense employs Dynamic Electrochemistry to extract a spectrum of information inaccessible to traditional static electrochemistry methods.

• IsoTis (Irvine, California), an orthobiologics company, said it has received FDA clearance to market its Accell family of products in the U.S. as Class II medical devices. The Accell family of products includes Accell 100, Accell Connexus and Accell Total Bone Matrix, as well as a new Accell product that is not currently marketed, IsoTis said. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in extremities and pelvis. Earlier this month Integra LifeSciences (Plainsboro, New Jersey) and IsoTis reported plans to merge (Medical Device Daily, Aug. 8, 2007). The combination would create a comprehensive orthobiologics portfolio, one of the largest sales organizations focused on orthobiologics in the U.S., and multiple cross-selling opportunities, according to IsoTis. Rob Morocco, CFO for IsoTis, told Medical Device Daily that the FDA clearance of its Accell family of products will have a positive impact on the merger with Integra and was, in fact, a condition of closing for that merger. “We think the Integra transaction is a good one for our shareholders and this is another step in getting that merger,” Morocco said. The transaction is subject to approval of IsoTis’ shareholders, as well as other closing conditions and approvals. If approved, IsoTis shareholders will receive $7.25 in cash for each share of IsoTis common stock they own, for a deal value of about $51 million, plus debt to be repaid at closing. Upon closing, expected in 4Q07, IsoTis will become a wholly-owned subsidiary of Integra. Integra will be one of the largest companies in the world focused on advanced technology in orthobiologics, IsoTis said.

• JALT Technologies (Manassas, Virginia) reported that successful validation tests on the ZenPure filter products were conducted by a third party independent laboratory and by extensive in-house manufacturing testing. JALT Technologies also reported the release of a validation guide to outline the results users can anticipate when using the PES capsules and mini cartridges. ZenPure filters are: U.S. Pharmacopeia (USP) and FDA compliant; manufactured using no adhesives, binders or surfactants; and, designed and distributed by true experts in the specialty filters field. ZenPure and JALT Technologies make service of filtration, separation, and purification products for liquids and gases.

• Lumedx (Oakland, California) has introduced cardiology software that automates donor/recipient record keeping for heart transplant centers, helping to streamline and simplify the process of collecting and managing adult cardiac transplant patient data from first consultation through evaluation, activation, transplant and post-transplant follow-up visits. The cardiac transplant module also allows the heart transplant center to track all donation offers and actual donor information for each patient, enabling the center to meet government record-keeping requirements. By automating, structuring and streamlining the process to collect information and record results, heart transplant centers can track, understand, and manage outcomes, as well as document quality of performance to patients, physicians, hospital administration, insurance carriers, and government. Lumedx provides fully integrated cardiovascular information systems.

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