Inside The Spinal Cord: InVivo Therapeutics Looks To Reverse Injury, Leverage Regulatory Reforms
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.
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In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.
Dozens of reforms impacting the medtech sector were signed into law Dec. 13, 2016, in the 21st Century Cures Act. Here's a breakdown of where things stand in the implementation of key provisions.
FDA stepped up efforts to implement the 21st Century Cures Act device provisions with actions to formalize an expansion of the Humanitarian Device Exemption program to include devices treating conditions that affect up to 8,000 patients, increase flexibility for the institutional review board process and specify validation requirements for certain reusable devices.