A decade ago, when Asia Pacific Medical Technology Chairman (APACMed) John Collings was running a medtech business in China, he was flying high with multiple rounds of investment under his belt and preparing to launch two new technologies, but the company hit a regulatory hurdle that delayed the launch and he found himself grappling for answers, he told the APACMed Forum held Sept. 5 in Singapore.
Product liability is always a point of concern for manufacturers of medical devices and other U.S. FDA-regulated products, and the broad contours of product liability jurisprudence are well known by corporate counsel. However, artificial intelligence products are rapidly pressing their way into routine clinical use, representing a technological shift that may occasionally deviate from the existing rules of the road where product liability is concerned.
Researchers from Case Western Reserve University and the U.S. Department of Veterans Affairs, continue their development of a neuroprosthetic which comprises a system of implanted or wearable sensors.
The U.K. Medicines and Health Care Products Regulatory Agency enacted its AI Airlock program for artificial intelligence – the agency’s branding for its regulatory sandbox for this type of medical software.
IGC Pharma Inc. has used its artificial intelligence (AI) modeling to identify the company’s proprietary molecule, IGC-1A, as a potential GLP-1 agonist. The company’s AI model compared IGC-1A and IGC-1C to established drugs such as Ozempic (semaglutide), tirzepatide, retatrutide and metformin, among others, and indicated that they could become effective options for metabolic disorders.
The $180 million Caresyntax GmbH recently raised in a series C extension round allows the company to accelerate the commercialization and adoption of its precision surgery platform, Bjorn von Siemens, CFO and CBO of Caresyntax told BioWorld.
In Ciconia Medical Inc.’s first patenting, the company’s founder and CEO, Roni Cantor-Balan, describes the development of a cervical measurement device for childbirth progress monitoring that replaces the manual vaginal examinations undertaken during labor.
The U.S. FDA’s device center is working to refine its regulation of artificial intelligence algorithms, but the agency is recommending that industry be more forward-thinking in a blog that urges device makers to fully adopt a life cycle management mindset for these systems.
Regulation of artificial intelligence for medical devices is still a developing space, but market competition authorities in the European Union, the U.K. and the U.S. are already examining the potential for anticompetitive behavior in this rapidly growing technological arena.
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