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BioWorld - Monday, January 26, 2026
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
Home » Topics » BioWorld MedTech, Regulatory

BioWorld MedTech, Regulatory
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Canada pinned on globe

Canada’s patent office speeding examination of COVID-19 med-tech applications, cutting company costs

Aug. 3, 2020
By David Godkin
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.
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Product image

Stryker stent system first indicated for aneurysms in back of the brain

Aug. 3, 2020
By Annette Boyle
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.
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Regulatory front for Aug. 3, 2020

Aug. 3, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed.
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Regulatory actions for Aug. 3, 2020

Aug. 3, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Stryker.
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Regulatory front for July 31, 2020

July 31, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Philips Respironics.
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Regulatory actions for July 31, 2020

July 31, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA Sciences, Clinical Reference Laboratory.
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Regulatory front for July 30, 2020

July 30, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for July 30, 2020

July 30, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7D Surgical, Abingdon Health, Ethicon, Quest Diagnostics, Seegene.
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Coronavirus vs U.S. wrecking balls

FDA posts template for at-home, OTC diagnostic tests for use in non-lab settings

July 29, 2020
By Mark McCarty
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.”
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Regulatory front for July 29, 2020

July 29, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Arthrex, Image Processing Technologies, Smith & Nephew.
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