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.
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.
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.
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.
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.
The FDA held a webinar directed toward the recent draft guidance for the accreditation scheme for conformity assessment (ASCA), but while independent labs figure to handle much of the related activity, FDA staff welcomed manufacturer's labs as well, emphasizing that the agency seeks the participation of all potentially interested parties.
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