Companies have invested billions for decades to crack the problem of treating the deep complexities involving stromal cancers, Phenomic AI CEO Girish Aakalu told BioWorld. Now he and his company are on the receiving end as they enter a new collaboration with Boehringer Ingelheim GmbH.
The U.S. Federal Trade Commission is clearly a more activist agency of late, although much of that activism has been around mergers and acquisitions. The latest FTC move, however, deals with investigative authorities that will be applied toward artificial intelligence (AI), which Katie Bond of Keller & Heckerman LLP said will give the agency considerable powers of discovery regardless of the merits of the enforcement action.
Astrazeneca plc launched a health-tech business aimed at bringing to market digital technological solutions that will optimize clinical trial design and delivery. The company, called Evinova, will offer solutions to reduce the time and cost of developing new drugs, bring care closer to patients at home and reduce the burden on health systems.
The U.S. FDA’s predetermined change control program (PCCP) is the talk of the med-tech town, but this novel regulatory mechanism has its limitations, said Cassie Scherer, senior director for digital health policy at Medtronic plc.
South Korea’s Ministry of Food and Drug Safety (MFDS) will head an international team of regulatory experts from 19 drug agencies worldwide, including the U.S. FDA and China National Institute for Food and Drug Control (NIFDC), to draft an international standard for artificial intelligence (AI)-based software.
The medical device industry might at times believe that it is the sole focus of the U.S. federal government thinking about cybersecurity, but the FDA is hardly alone in leaning hard on industry to stand up a solid cybersecurity regime. The Securities and Exchange Commission (SEC) is also turning the screws on corporate America regarding cybersecurity as seen in enforcement against Solarwinds Corp., an enforcement action that Seth Carmody of Medcrypt Inc., said highlights the breadth of regulatory hazards for the med-tech industry.
The U.S. FDA’s approach to bias covers a large swath of territory, including the potential for bias to creep invisibly into artificial intelligence (AI) products. Yarmela Pavlovic, vice president for global regulatory affairs at Medtronic plc, said at this year’s Artificial Intelligence Summit that regulators may be more wary of the potential hazards of bias in AI compared to non-AI software simply because of the difficulty in anticipating how bias might affect the function of these advanced algorithms.
Lunit Inc. is the latest South Korean firm to gain the U.S. FDA’s 510(k) clearance for Lunit Insight DBT, its artificial intelligence (AI)-powered breast cancer diagnostic tool that analyzes digital breast tomosynthesis (DBT) images, boosting its efforts to enter the U.S. market. The company also reported that it secured $150 million in a public offering.
In the following years, 2023 may come to be seen in medical device circles as the year of artificial intelligence (AI), but that doesn’t mean that 2023 will be seen as the year of regulatory clarity for AI.
Day Zero Diagnostics Inc. and Oxford Nanopore Technologies plc (ONT) joined forces to battle the leading cause of death in hospitals — sepsis. Combining Day Zero’s whole genome sequencing technology for pathogen identification and antimicrobial susceptibility analysis with Oxford’s nanopore-based molecular sensing technology, the companies aim to develop a diagnostic system that provides potentially life-saving identification and guidance on antimicrobial selection in mere hours.