HeartSciences Inc. (Nasdaq: HSCS) ("HeartSciences" or the "Company"), a healthcare information technology ("HIT") company focused on advancing electrocardiography ...

A research team led by Senior Researcher Chanyong Park, Principal Researcher Dongkyu Lee, and Postdoctoral Researcher Changha ...

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

"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 ...

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

Atom Therapeutics, a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, today announced FDA approval of a Phase II clinical trial ...

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) (“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” ...

This company has lodged a key submission which will pave the way for sales of its heart failure software in the large US ...

The agency in July warned WHOOP that its blood-pressure insights feature made the company's wearable product look more like a medical device as it estimated systolic and diastolic values used in ...