Consumer advocacy groups urged the U.S. House of Representatives to take a stronger hand in promoting safety in medical devices during a hearing today on the re-authorization of the medical device user fee act.
Industry officials and venture capitalists highlighted the role the med-tech sector plays in creating high-paying jobs and generating innovative, life-saving products. Consumer advocates were having none of that, chiding the user fee negotiations for putting safety on the back burner under pressure for faster review times.
Group purchasing organization Premier said it signed a raft of supply deals for a variety of medical device products.
The Charlotte-based GPO said it signed deals for endomechanical, trocar, suture and topical skin adhesives with 16 companies.
Terumo Americas Holding, the U.S. subsidiary of Japan’s Terumo Corp., acquired Onset Medical Corp., makers of access sheath technology for multiple minimally invasive applications.
Terumo is a $4 billion a year company with sales and operations in more than 160 countries, according to a press release. The value of the acquisition wasn’t made public.
CaridianBCT and Terumo Transfusion unveiled plans to join the two companies into Terumo BCT at this year’s American Assn. of Blood Banks meeting.
The two companies will operate independently until spring 2012 when they will combine to form blood component technology company Terumo BCT.
The FDA granted Kimberly-Clark Health Care the first 510(k) clearance for a single-use pediatric face mask.
Designated as a Class II medical device, the colorful mask is used to protect the respiratory tracts of children ages five to 12 from various bacteria, viruses and pathogens. It’s intended for use in waiting rooms and hospitals, to protect already immuno-compromised children from further infection
Boston Scientific Corp. (NYSE:BSX) could be positioned to gobble up some two-thirds of the business left on the table by Cordis Corp. in the U.S., according to research released by the Millennium Research Group.
The U.S. Food & Drug Administration slapped three medical device companies with Class 1 recall status for their heart devices.
GE Healthcare added another MRI technology to its imaging portfolio with the acquisition of Minneapolis-based Steady State Imaging.
SSI’s imaging platform is based on the University of Minnesota-developed SWIFT (Sweep Imaging with Fourier Transformation) method, which gives radiologists the ability to see tendons, ligaments and other tissues, an imaging capability not available in conventional imaging methods, according to GE Healthcare.
Updated March 22, 2011, 3:25 P.M. with material sourced from the FDA.
Terumo Cardiovascular Systems must pay the FDA $35 million and won’t be able to sell some of its products until it completes an FDA-approved plan to fix manufacturing problems at a plant in Ann Arbor, Mich.