Regulatory

Ottawa recruits Canadian equipment makers in CA$2B COVID-19 battle

April 3, 2020

TORONTO – Canadian Prime Minister Justin Trudeau has yet to rule out following U.S. President Donald Trump’s lead by invoking his nation's wartime Defense Procurement Act compelling manufacturers to begin making ventilators to combat COVID-19. For now, Ottawa has signed contracts or letters of intent with eight equipment makers.

FCC doubles down on existing telehealth pilot, draws raves from advocates

April 3, 2020

By Mark McCarty

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The U.S. Federal Communications Commission (FCC) has received funds for another telehealth program in less than a year. An agency statement indicates that the program “would immediately support health care providers” working to thwart the COVID-19 outbreak. This would be achieved in part by supporting purchases of devices and other items needed to provide telehealth, which the Connected Health Initiative said will help drive an overdue overhaul of health care in the U.S.

Regulatory front for April 3, 2020

April 3, 2020

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The latest global regulatory news, changes and updates affecting medical devices and technologies.

Regulatory actions for April 3, 2020

April 3, 2020

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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Beroni Group, Biogx, Clinical Laserthermia Systems, Leica Biosystems.

China tightens grip on med-tech exports to plug loopholes after complaints

April 2, 2020

By Elise Mak

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BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.

FDA greenlights Outset Medical’s Tablo for home dialysis

April 2, 2020

By Meg Bryant

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With the COVID-19 pandemic overwhelming hospitals and treatment centers, San Jose, Calif.-based Outset Medical Inc. scored a big win with U.S. FDA clearance of its Tablo hemodialysis system for home dialysis use. The company will begin rolling the system out for home patients in the coming months, balancing that program with demand for onsite devices to support an upswell in COVID-driven dialysis treatments.

Regulatory front for April 2, 2020

April 2, 2020

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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Cellex, Ipsum Diagnostics, Refocus Group.

COVID-19 strikes again: U.S. lawmakers say longer comment periods needed

April 2, 2020

By Mari Serebrov

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Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.

Oncosil wins CE mark, breakthrough designation for pancreatic cancer device

April 1, 2020

By Tamra Sami

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PERTH, Australia – The British Standards Institute (BSI) granted Sydney-based Oncosil Medical Ltd. European CE marking approval for its brachytherapy device to treat locally advanced pancreatic cancer in combination with chemotherapy, clearing the way for marketing in both the EU and the U.K. BSI also granted the Oncosil device breakthrough therapy designation.

FDA nod for ABM Respiratory Care’s Biwaze Cough system

April 1, 2020

By Meg Bryant

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Charleston, S.C.-based startup ABM Respiratory Care has received U.S. FDA clearance for its first product, an airway clearance system known as Biwaze Cough. The portable device helps to remove secretions for people who are unable to cough or clear away secretions effectively on their own due to injury or disease.