Korea's first fully automated diagnostic system capable of simultaneously detecting 16 major foodborne pathogens within one ...
Clearance extends Pearl's FDA-validated radiologic AI platform to enable real-time detection of key dental pathologies across the world's most widely used type of extraoral radiograph.
InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...
HeartSciences Inc. (Nasdaq: HSCS) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the ...
HeartSciences Inc.(Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT” ...
In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...
The "Validation of FDA-Regulated Systems Used in Drug Development & Submissions Using Artificial Intelligence (AI), Machine Learning (ML) & Large Language Models (LLMs), such as ChatGPT (August 28, ...
BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...
Reno, Nevada (UroToday.com) -- Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug ...
Philips (NYSE: PHG) + has announced it received FDA 510(k) clearance for its deep-learning reconstruction tool, SmartSpeed Precise. SmartSpeed Precise can scan up to three times faster and produce ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results