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Latest From David Filmore
InVivo Therapeutics is looking to build on a breakthrough in understanding the pathophysiology of spinal cord injury to bring the first device to market for partially reversing the debilitating condition. The firm is dealing with a cautious FDA in its pivotal-trial development, but also looking to leverage a new US policy for humanitarian-use devices to expedite its path to market expansion.
The US agency has exempted 72 different class I device types from the 510(k) requirement, effective April 13, using a procedure laid out by the 21st Century Cures Act. A majority of the products are in vitro diagnostics and reagents, but there also devices such as patient beds, restraints and first-aid kits.
While the two US-based medical device lobby groups, AdvaMed and MDMA, may have butted heads in the past, they are showing an increasing level of cooperation, most recently with plans to partner on the upcoming Medtech Conference in San Jose.
The German-headquartered firm is making a play to enter the US vascular intervention market, with two stents approved by FDA under original PMAs in the first quarter of 2017. Cardiovascular devices, in general, have gained the most novel-device approvals so far this year, followed by IVDs. Check out more from a Q1 look at US FDA approvals and clearances monitored by Medtech Insight's Approvals Tracker.
Donald Rucker, who spent 13 years as chief medical officer of Siemens Healthcare, has been tapped as the US National Coordinator of Health IT, according to a government directory listing.
The House Republican conference decision to pull the American Health Care Act from consideration means repeal of the medical device tax has died, at least in the short term. After hours of debate on the floor, and failing to gather enough votes to pass the bill, House Speaker Paul Ryan and President Trump called a halt to the Affordable Care Act repeal effort, saying they will now focus on other objectives, such as tax reform.