HONG KONG – Indonesian regulators have introduced a medical device risk classification system, as part of a harmonization of regulations across the Association of Southeast Asian Nations (ASEAN) region. The 'Sistem Klasifikasi Risiko Alat Kesehatan' system, known by the acronym Siklara, takes its cues from the ASEAN Medical Device Directive (AMDD).
The U.S. FDA's overhaul of the 510(k) program continues apace with the recent final guidance for the special 510(k) mechanism. However, a member of the FDA staff said clerical errors account for a conspicuous number of conversions of these applications to traditional 510(k)s than any other problem. The agency posted the final guidance for the special 510(k) program in September with features seen in the draft that drew opposition from device makers.
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.
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.
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