The stock of molecular diagnostics company T2 Biosystems Inc. spiked 10 percent due to a $40 million equity investment from Melville, N.Y.-based Canon U.S.A. Inc., made in return for a nearly 20 percent stake in the firm.
The FDA is making review and regulation of neurological devices a priority, thanks to the plethora of innovative med tech related to brain conditions, such as stent retrievers for treating stroke. Other recently approved devices include the Deka Arm System, the first prosthetic arm that translates signals from an individual's muscles to perform tasks, and the first medical device to prevent migraines, dubbed Cefaly.
Marlborough, Mass.-based Boston Scientific Corp. is backing a venous stent maker to the tune of $25 million in equity financing, making it the largest investor in the company. The series D round is expected to enable St. Louis-based Veniti Inc. to complete a U.S. clinical trial of its Vici Venous Stent System.
The FDA is recommending nationwide testing of donated blood for the Zika virus in a bid to eliminate another transmission vector of the disease. Zika can cause pregnant women to give birth to babies with abnormally small heads, a condition known as microcephaly, or other brain defects.
As the government ramps up its response to the Zika virus scare, Bethlehem, Pa.-based Orasure Technologies Inc. will receive up to $16.6 million from the U.S. Department of Health and Human Services to develop a rapid molecular diagnostic that tests for the disease's antibodies. The funding comes from the agency's Biomedical Advanced Research and Development Authority.
Toronto-based Titan Medical Inc. is facing a shortage of R&D funding for its single-port Sport Surgical System robotic surgery device. The company is now scrambling for cash instead of FDA clearance.
Over the summer the CFDA proposed a new expedited review program for high-priority devices, but it excludes foreign devices from participation, to the chagrin of industry players around the world.
