August 14, 2015

Wanted: Input on MDUFA Reauthorization

What do you want to see in the next Medical Device User Fee Amendments cycle? The FDA would like to hear your answer at an upcoming stakeholder meeting scheduled for next month. The meeting, slated for Sept. 15 at the agency’s White Oak campus in Silver Spring, Md., is one of several designed to gather stakeholder feedback on how the FDA can improve the program. Interested parties may register by visiting www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm458184.htm. Statutory authority for MDUFA expires Sept. 30, 2017. New legislation then will be required for FDA to continue collecting user fees for the medical device program.

DexCom, Google to Form Diabetes Alliance

DexCom and Google’s life sciences group are teaming up to develop a series of next-generation continuous glucose monitoring products that are smaller and less expensive than currently marketed offerings. The products will incorporate Google’s miniaturized electronics platform with DexCom’s sensor technology. Initially, the two will focus on disposable products for use across all diabetes markets. Under the agreement, DexCom will retain all sales and distribution rights for the products developed under this agreement. It will hand over upfront and milestone payments during development, as well as revenue-based royalties once these products are launched and have achieved a certain level of revenue.

Emphysema Treatment Gets Thumbs Up

Uptake Medical has scored the CE Mark for its InterVapor system, which uses water vapor to treat patients with heterogeneous upper lobe emphysema. The CE mark follows a multicenter randomized-controlled study of patients in Europe and Australia. According to a company statement, there are limited treatment options for patients with severe emphysema. The InterVapor platform is in testing for regional lung tumor ablation in patients with early stage lung cancer and lung metastases.

Mallinckrodt to Sell CMDS Business

Mallinckrodt is selling its global contrast media and delivery systems business to French medical imaging firm Guerbet for $270 million. The transaction aligns with Mallinckrodt’s strategy to streamline its portfolio and focus resources on higher-growth, higher-margin specialty brands and its generic business, the company says. The deal is expected to close in the next few months.

Mesa Snags Sterilizer Testing Business

Lakewood, Colo.-based Mesa Laboratories has acquired most of the assets of the dental sterilizer testing business of North Bay Bioscience for $11.25 million. The bulk of North Bay’s business involves weekly testing, of table-top sterilizers in the U.S. dental industry to determine if they meet federal and state standards. Mesa has retained all of North Bay’s employees, including the management team, and will continue to operate the business from North Bay’s Traverse City, Mich., facilities.