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BioWorld - Saturday, August 13, 2022
Home » Topics » Regulatory

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Regulatory front

Oct. 31, 2019
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The latest global regulatory news, changes and updates affecting medical devices and technologies.
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CMS drops references to late-stage cancers in draft rewrite of NGS coverage memo

Oct. 31, 2019
By Mark McCarty
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The U.S. Centers for Medicare and Medicaid Services (CMS) has posted a draft rewrite of the coverage memo for next-generation sequencing (NGS), and while the draft rewrite fails to address a number of concerns, the agency eliminated references to advance-stage cancer, opening the door to considerably greater utilization.
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Regulatory front for Oct. 30, 2019

Oct. 30, 2019
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The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front

Oct. 30, 2019
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies.
Read More

WHO looks to shape future of digital health, reduce risk of a 'negative outcome'

Oct. 30, 2019
By Nuala Moran
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LONDON – The World Health Organization (WHO) aims to hit back at anti-vaccination campaigners and take a role in ensuring the safety of consumer-targeted health apps, as part of a broader push to exert more influence in shaping digital technologies to meet global public health needs.
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FDA sign

FDA says STeP program 510(k)s may be subject to uncertainty guidance

Oct. 30, 2019
By Mark McCarty
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The FDA's guidance for uncertainty of benefit-risk provided some clarity on the benefit-risk question, but the terms of the "uncertainty" guidance could apply to the agency's Safer Technologies Program (STeP) despite that the STeP program applies to 510(k) devices, which are excluded from the scope of the uncertainty guidance.
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Surmodics scores breakthrough device designation for Sundance SCB catheter

Oct. 30, 2019
By Liz Hollis
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Surmodics Inc., of Eden Prairie, Minn., said the U.S. FDA has granted a breakthrough device designation to its Sundance sirolimus-coated balloon (SCB) catheter to potentially help those suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease.
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FDA Approved seal

Heartvista's AI-assisted cardiac MRI tool cleared

Oct. 30, 2019
By Meg Bryant
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Los Altos, Calif.-based Heartvista Inc. has received the U.S. FDA's nod for its One Click autonomous MRI acquisition software for cardiac exams. The company said that One Click is the first artificial intelligence (AI)-assisted solution designed specifically with the goal of enhancing the performance and results of cardiac MRI scans.
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Regulatory front

Oct. 29, 2019
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The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Patient receiving dialysis

Fresenius gets breakthrough designation for hemodialysis system to prevent blood clots

Oct. 29, 2019
By Stacy Lawrence
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The U.S. FDA has granted a breakthrough device designation for a new hemodialysis system from Fresenius Medical Care Holdings Inc. The device is designed to prevent blood blotting without the use of blood-thinning medication, such as heparin, that most dialysis patients require.
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