Becton, Dickinson, and Co. buys C.R. Bard

House bill to streamline device accessory approval; Olympus to acquire Image Stream Medical; UL acquires Emergo

BD (Becton, Dickinson, and Co.) will acquire C.R. Bard for $24 billion. The boards of directors at the companies unanimously approved the merger.

The combined company will build on BD’s position in medication management and infection prevention with an expanded offering of solutions. Bard’s product portfolio and pipeline will increase BD’s opportunities in fast-growing clinical areas. http://www.bd.comhttp://www.crbard.com

House bill to streamline device accessory approval

The Risk Based Classification of Accessories Act, a bipartisan bill being considered in Congress, would require the U.S. Food and Drug Administration (FDA) to revise regulations for the reclassification of previously approved, low-risk medical devices. The bill aims to address the hundreds of device accessories currently on the market which may be inappropriately classified, and streamline the process.

According to Rep. Annie Kuster (D-N.H.), who introduced the bill with Rep. Mimi Walters (R.-Calif.), an accessory, such as a plastic tray packaged with a medical device, is required to comply with the same regulations as artificial heart valves, and the bill would clarify that these items “don’t need to be tested to the same degree as a high-powered eye surgery laser.”

Kuster notes that it is common sense that an accessory that does not impact the safety of a device should not need to go through the cumbersome process for FDA approval. http://www.fda.gov

Olympus to acquire Image Stream Medical

Center Valley, Pennsylvania-based Olympus Corp. of the Americas will acquire Littleton, Massachusetts-based Image Stream Medical, makers of software designed to connect hospital imaging equipment and systems. Company leaders say the deal will build a global systems integration platform using the Image Stream technology.

“We believe the acquisition of Image Stream Medical will accelerate our progress in achieving the universal goals of healthcare reform and furthers our ability to achieve our mission of contributing to society by making people’s lives healthier, safer, and more fulfilling around the world,” says OCA President & CEO Nacho Abia. www.imagestreammedical.com; http://www.olympusamerica.com

UL acquires Emergo 

 

Global safety science firm UL has acquired Emergo, an Austin, Texas-based privately held firm that provides regulatory value-added services and market access services to medical device manufacturers.

The acquisition combines UL’s global regulatory approval support services for the health sciences industry with Emergo’s global medical device registration expertise.

UL plans to retain Emergo’s Austin headquarters and its global offices. Emergo’s president and CEO, Rene Van De Zande, and its more than 200 employees will remain with the company. https://www.emergobyul.com/

 

June 2017
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