BD, Apax to Form $500M Joint Venture
Becton, Dickinson and Company has entered an agreement to sell 50.1 percent of its Respiratory Solutions business to Apax Partners to form a joint venture. The joint venture, which will operate as an independent company, will consist of Respiratory Solutions in its entirety, including Ventilation, Respiratory Diagnostics, Vital Signs and Airlife. BD will maintain a non-controlling minority stake in the JV. The transaction falls just under $500 million and is expected to be completed by late fiscal year 2016 or early fiscal year 2017. BD expects a share reduction of $0.10 to $0.14.
Prism Medical Nabs CE Mark
Prism Medical has secured the CE mark for its ProteXsure Safety Capsule System, intended for the prevention of needle stick injuries. The approval is the first indication for the company’s Prism platform. Globally, there are 3.5 million reported cases of NSI’s every year.
Edwards Lifesciences Secures Approval
The Japanese Ministry of Health, Labor and Welfare has granted approval to Edwards Lifesciences’ SAPIEN 3 transcatheter heart valve for the treatment of severe symptomatic aortic stenosis. The device is approved in 20-, 23-, 26 and 29-mm sizes and features an outer skirt seal to prevent paravalvular leak. The valve snagged commercial approval in the U.S. in June 2015 and in Europe in January 2014. A full product launch is expected toward the end of the year.
Roche Introduces DISCOVERY Yellow Kit
Switzerland-based Roche has launched the DISCOVERY Yellow Kit, the latest addition to its suite of VENTANA modular-based detection kits for uncovering cancer biomarkers and tumor cell populations. The kit features alkaline phosphatase-based detection chemistry and produces a yellow indicator that is not erased during alcohol dehydration, the company says. The kit is intended for use in combination with chromogens for identifying signal co-localization.
Greatbatch Completes Nuvectra Spin-Off
Greatbatch has completed the spin-off of QiG Group, which previously changed its name to Nuvectra. Under a long-term supply agreement, Greatbatch will manufacture Nuvectra’s first implantable device, the Algovita spinal cord stimulation system, which is approved in the U.S and Europe. Nuvectra will focus on neurostimulation technology.
MHRA Warns of Hearing Aid Batteries
The UK’s Medicines and Healthcare products Regulatory Agency is warning that certain ZeniPower mercury-free hearing aid batteries may explode. No injuries have been reported through the MHRA’s Yellow Card Scheme safety monitoring system, the agency says. Due to a manufacturing fault, there is a low risk of the batteries exploding during use or if depleted, says John Wilkinson, MHRA’s director of medical devices. The affected batteries have best before dates of August 2018 and September 2018. No other batches are affected.