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.
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.
The first patenting from Hemeo BV describes its development of Vantage, an artificial intelligence powered clinical decision support software for coagulation management.
Zimmer Biomet Holdings Inc. reported it will buy Orthogrid Systems Inc., a company that makes artificial intelligence-driven surgical guidance systems for total hip replacement for an undisclosed amount, and expects to complete the deal by the end of the fourth quarter of 2024.
In what represents just the second PCT filing to have emerged from Valar Labs Inc., the company’s co-founders – Joshi Anirudh, Viswesh Krishna, and Damir Vrabac – describe their development of an AI-derived histologic signature for predicting patient outcomes to treatments for pancreatic cancer.
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.
In Pumpkinseed Technologies Inc.’s first public patenting, the company’s co-founders describe their development of new proteomics platform that merges nanotechnology, biochemistry, silicon photonics and machine learning for high-resolution phenotyping to deliver new biological insights.
Artificial intelligence might solve a world of cost issues for medical science, but the results of a recent study suggest that the day has not yet come when hospitals and doctor’s offices can just feed data into a computer and expect a reliable and intelligible diagnosis.
