Neovasc Inc. is targeting two highly underserved markets in cardiology – refractory angina and mitral valve disease – with unique transcatheter solutions. The angina device, called the Neovasc Reducer, is expected to enter the European market early next year.
Venture capitalists still might find medical devices to be among the more difficult sectors to place their money, but the overall mood of device investors is improving. Device VCs are encouraged by increasing opportunities on Wall Street along with interest from corporate investors, but limited partners and the FDA remain primary concerns.
St. Jude Medical has acquired Swiss company Endosense, a pioneer in the field of contact force sensing for atrial fibrillation ablation. The $170 million plus milestones deal will enable St. Jude to compete more effectively against market leader Biosense Webster/J&J, but it also emphasizes the growing importance of contact force technology in the AF ablation space.
Industry trade groups reacted positively to a compromise measure on medical device and diagnostics reform approved by the European Parliament Oct. 22. The groups had strongly opposed an earlier version. It remains unclear whether there will be enough time to fashion a law before 2014 elections.
Cook Medical’s Zilver PTX stent and Second Sight Medical Products’ Argus II retinal prosthesis system will enjoy new-technology add-on payments in 2014 under CMS’ hospital inpatient prospective payment system final rule.
Vigilant Biosciences Inc.’s screening kit for diagnosing early-stage oral cancer comprises a test strip to detect oral cancer biomarkers, and an oral gargle-and-spit rinse. The screening is designed to occur annually at dental check-ups and it can be administered by a hygienist.
To the surprise of many, the FDA issued a “not approvable” letter to Wright Medical Group for its Augment biologic bone graft. Now company executives must figure out what to do next to grow in the extremities space.
After the two-week shutdown, FDA staff are facing a backlog of fiscal year 2014 device submissions. The agency says it is working on a plan and assessing its ability to meet its MDUFA III commitments. The bigger concern, however, may be the regulatory uncertainty created by the short-term deal in Congress.
Supreme Court asks solicitor general to weigh in on a suit against Medtronic with implications for federal pre-emption. In other Supreme Court updates, the court decided not to hear a completely separate appeal from Medtronic on a TAVR patent infringement suit; and a physician is trying to bring his stent patent case against Johnson & Johnson to the high court.
A $23 million Series E financing round that closed in June will allow Vertos Medical Inc. to further expand commercialization of its minimally invasive mild procedure for patients with lumbar spinal stenosis.
