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.
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.
Neurophet Inc. pulled in ₩20 billion (US$15.1 million) in its series C funding round, helping roll out its AI-software suite for neurodegenerative diseases worldwide and prep its IPO on the Kosdaq which is scheduled to take place sometime in 2024.
A number of recent developments in artificial intelligence (AI) have sent some reassurance that these algorithms will not hit the market completely devoid of regulation, but a Nov. 8 hearing in the U.S. Senate makes clear that Capitol Hill is intent on legislating on AI, even if only belatedly.
As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget (OMB) has promulgated a memorandum directing federal government agency use of AI.
Quibim SL and Royal Philips NV have teamed up to utilize their artificial intelligence (AI)-enabled solutions to help clinicians deliver faster diagnosis and treatment of patients with prostate cancer. The partnership will see Philips AI-based magnetic resonance (MR) imaging technology integrated into Quibim’s AI based QP-Prostate software, to automate real-time prostate gland segmentation in MR images, and generate meaningful quantitative insights, as well as standardize MRI prostate exam reporting.
As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget (OMB) has promulgated a memorandum directing federal government agency use of AI.