TORONTO – Dishing out hundreds of millions of dollars for new COVID-19 fighting ventilators, test kits and antibody detection platforms Ottawa has another vital gap to close: the time it takes to approve these technologies for the marketplace. A new Canadian pilot program could significantly reduce the amount of time it takes to determine if these technologies are ready for prime time.
The U.S. FDA expanded the indications for Stryker Corp.’s Neuroform Atlas stent system to include use in the posterior circulation or back of the brain, making the device the only adjunctive stent approved for aneurysms in this challenging location. The Kalamazoo, Mich.-based company’s intracranial coil-assist stent gained its initial indication for the more common aneurysms in the anterior circulation of the neurovasculature in May 2019.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Stryker.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA Sciences, Clinical Reference Laboratory.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7D Surgical, Abingdon Health, Ethicon, Quest Diagnostics, Seegene.
The U.S. FDA has nudged the emergency use authorization (EUA) program forward once again, this time with a template for applications for tests that can be performed entirely at home, in the office and at schools. FDA Commissioner Stephen Hahn said in an accompanying statement that tests of this sort “will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Arthrex, Image Processing Technologies, Smith & Nephew.