The European Union’s Medical Device Coordination Group (MDCG) continues to churn out guidances for the new Medical Device Regulations (MDRs), but there are several nagging questions about devices granted market access under the legacy system. MDCG has clarified that these devices will be subject to postmarket surveillance requirements under the MDR system rather than the previous system, although it is not a simple process to determine when this approach does and does not apply.

Vuno Inc. has received its third breakthrough device designation from South Korea’s Ministry of Food and Drug Safety (MFDS), for its artificial intelligence (AI)-based electrocardiogram (ECG) analysis software Vuno Med DeepECG. Vuno is the first company to have three such designations to its name. “We developed Vuno Med DeepECG via long-term ECG data analysis research. With this breakthrough designation, we target expanding our market share in the medical AI industry via our bio-signal businesses. Among these is ECG data, which can help diagnose various heart diseases and has high potential,” Yeha Lee, chairman at Vuno, told BioWorld.

PERTH, Australia – Medical device stakeholders generally opposed the Therapeutic Goods Administration’s (TGA) proposal to refine regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin. The agency received 45 comments, 17 of which came from medical device manufacturers or associations representing device manufacturers or sponsors, and most of those comments did not support the proposal to refine the regulations.

The FDA granted Cardialen Inc. an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF). MPT is a low-energy electrical pulse therapy aimed at restoring abnormally rapid heart rates, such as AF, to a regular rhythm to reduce the potential for high-energy shocks. Studies have shown that almost 1 in 4 patients experience anxiety or depression after receiving an implantable cardioverter defibrillator (ICD).

The Health Breach Notification Rule set forth by the U.S. Federal Trade Commission in 2009 was not initially directed toward health apps used strictly for non-medical uses, but the FTC has indicated it will enforce the rule for developers of these non-medical apps as well. The risk is substantial for these developers as the civil penalties for breaches can reach $44,000 per violation per day, which in the case of a mass breach could present a profound financial risk.