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BioWorld - Sunday, December 21, 2025
Home » Topics » Regulatory

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Telehealth illustration

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

April 3, 2020
By Mark McCarty
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.
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Regulatory front for April 3, 2020

April 3, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for April 3, 2020

April 3, 2020
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.
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Regulatory actions for April 3, 2020

April 3, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytodyn, Gracell, I-Mab, Iveric, Novan, Revive.
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Flag of China and masks

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

April 2, 2020
By Elise Mak
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.
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4-2-Outset-Medical-tablo.png

FDA greenlights Outset Medical’s Tablo for home dialysis

April 2, 2020
By Meg Bryant
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.
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Regulatory front for April 2, 2020

April 2, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Cellex, Ipsum Diagnostics, Refocus Group.
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COVID-19 strikes again: U.S. lawmakers say longer comment periods needed

April 2, 2020
By Mari Serebrov
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.
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FDA approves Sevenfact for hemophilia A and B

April 2, 2020
Oncosil-CEO-Kenny.png

Oncosil wins CE mark, breakthrough designation for pancreatic cancer device

April 1, 2020
By Tamra Sami
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.
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