A Medical Device Daily Staff Report

Ethicon Endo-Surgery (Cincinnati) Energy business, has entered into a collaboration agreement with Megadyne (Draper, Utah), makers of electrosurgery. Per the terms of the agreement, Ethicon and Megadyne will now offer contracting solutions for customers in the U.S. that will increase choice and access to a broad energy portfolio across multiple energy platforms, from monopolar and standard bipolar currently offered by Megadyne to advanced bipolar and ultrasonic currently offered by Ethicon.

"This combined offering provides our hospital system with a comprehensive portfolio of solutions for our energy needs," said Sonja Glass, RN, Value Analysis Coordinator for Surgical Services, Strategic Sourcing [Wake Forest Baptist Medical Center, Winston Salem, North Carolina]. "I believe Ethicon and Megadyne provide high quality products that help us deliver quality outcomes for our patients. The strategic partnership helps drive cost efficiencies and provides financial benefits for Wake Forest Baptist."

The companies say the collaboration not only provides customers greater choice of energy solutions to simplify their inventory management, but we can now also offer increased value through flexible contracting solutions, capital trade-out programs, product and supplier standardization and environmentally friendly solutions.

Ethicon is a leader in advanced energy solutions and offers the broadest portfolio of ultrasonic energy devices using Harmonic technology and advanced bipolar energy devices using Enseal technology.

Harmonic ultrasonic devices combine precision and multifunctionality: With a jaw and blade uniquely designed for precise dissection, sealing and transection, one device enables surgeons to perform multiple jobs without instrument exchanges. Enseal delivers high uniform compression along the entire length of the jaw, and seals vessels up to 7 mm in diameter.

In other agreements/contracts news:

• OraSure Technologies (Bethlehem, Pennsylvania) has reached an agreement with Thermo Fisher Scientific (Minneapolis), to develop and supply up to 12 homogenous fully automated oral fluid drugs of abuse assays to be used with a new Intercept oral fluid specimen collection device. OraSure will have the right to purchase and resell the assays in the U.S. and in certain foreign countries, subject to receipt of applicable regulatory approvals.

OraSure also said that although its prior assay collaboration agreement has been terminated, certain assays developed under that collaboration will remain available on a transitional basis for use with OraSure's existing Intercept collection device.

Under this new agreement with Thermo Fisher, a NIDA-5 panel of assays is expected to be initially sold with the next generation Intercept device in the domestic criminal justice and forensics markets beginning in the second half of 2014. Eventually, the parties expect to complete development of several more assays and obtain FDA 510(k) clearance and approvals in certain foreign countries. The assays will be optimized as needed to comply with new oral fluid guidelines expected to be issued by the Substance Abuse and Mental Health Services Administration (SAMHSA) for the federally regulated market and certain other markets that follow Federal drug testing guidelines, none of which are currently served by OraSure.

OraSure's current Intercept Oral Fluid Drug Testing System was the first FDA-cleared in-vitro diagnostic laboratory-based oral fluid drug testing system, and is the only one that is FDA cleared for detection of nine commonly abused drugs, including marijuana, cocaine, opiates, PCP, amphetamines, methamphetamine, barbiturates, methadone and benzodiazepines.

• VuComp (Plano, Texas) reported an agreement with Konica Minolta Medical Imaging (Wayne, New Jersey) to include VuComp's M-Vu CAD, the first mammography CAD product clinically proven in a pivotal reader study, as companion technology for Konica Minolta's high resolution Regius Mammography systems. The agreement provides VuComp the ability to market its advanced CAD system through Konica Minolta's U.S. distribution network.

Jeff Wehnes, president/CEO of VuComp, said, "We are delighted to offer our M-Vu CAD system as part of Konica Minolta's mammography product line. This brings us another step closer to our goal of becoming the world's leading provider of CAD products, helping radiologists provide the best possible care to women."

Konica Minolta Medical Imaging makes medical diagnostic primary imaging. VuComp makes advanced cancer detecting technologies.

• ActiveCare (Orem, Utah), a provider of diabetes management wellness services, reported an agreement to provide their diabetes wellness solution for International Benefits Administrators (IBA) of Long Island, New York. Deployment to IBA's member base will potentially add several thousand new members to the ActiveCare disease management program.

"Through their revolutionary diabetes monitoring system ActiveCare will allow us to better meet the needs of IBA plan members suffering from diabetes," said Michael Lagalante, President of International Benefits Administrators. "Historically this data and insight has not been available. With ActiveCare we will have the real-time data and personal care services to empower our members to gain better control of their diabetes while continuing our tradition of efficient plan management."

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