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 ...

The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...

HeartSciences Inc.(Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT” ...

Pearl, the global leader in AI solutions for dentistry, today announced that the U.S. Food and Drug Administration (FDA) has ...

HeartSciences Inc. (Nasdaq: HSCS) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the ...

Bioassay variability can pose significant challenges due to laboratory conditions, instrumentation, analytical software, cell ...

This biotechnology company has lodged a key submission which will pave the way for sales in the large US market.

"2025 has been a pivotal year where our commitment to evidence-based clinical innovation was converged with rigorous operational execution," said Clarius CEO Laurent Pelissier. "Achieving ...

Policymakers across Europe and the United States are moving to classify many clinical AI tools as high-risk systems, ...

Curvebeam AI reckons the shortest path to better surgery starts with one scan, one visit and patients on their feet.