Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a ...
Korea's first fully automated diagnostic system capable of simultaneously detecting 16 major foodborne pathogens within one ...
The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.
A research team led by Senior Researcher Chanyong Park, Principal Researcher Dongkyu Lee, and Postdoctoral Researcher Changha ...
Abstract: The development of reliable software depends heavily on the effective collaboration between teams responsible for development and testing. Despite ongoing efforts, many software programs ...
Risk is a lens, not a leash. Once teams see what truly threatens patients and processes, the busywork falls away, and quality ...
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 ...
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