On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Even after years of work, courts still have a long way to go: 63% of cases in Superior Courts and Municipal Courts still need ...
A device long used by adults to manage migraines was now available for children as young as eight years old, offering new ...
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...
Huxley Medical, a commercial-stage medical technology firm focused on streamlining detection of sleep and heart disorders, has received clearance from the U.S. Food and Drug Administration ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Eko Health has been advancing the use of artificial intelligence to help providers detect the early signs of disease, ...
The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures ...
Lipoprotein(a) has long been recognized as a critical marker for people at risk of cardiovascular disease. However, the health care industry has lacked the tools to tackle the problem.
RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.
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