The FDA granted a second 510(k) clearance this week to CareTaker, a Charlottesville, Virginia connected medical device company. CareTaker's device of the same name is a wearable, connected blood ...
CAMBRIDGE, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (PRME), a biotechnology company committed to delivering a new class of differentiated, one-time curative genetic therapies, ...
ViTAA Medical Solutions Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance for AiORTA™ Plan, the company’s fully automated, hyper-precise aortic ...
The FDA has granted clearance for the first AI-powered handheld medical device to assist physicians in detecting all three common skin cancers: basal cell carcinoma, squamous cell carcinoma, and ...
BOSTON--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for ...
Vektor Medical Receives FDA 510(k) Clearance Adding Atrial Flutter Mapping, Enhanced Connectivity and New Integration Capabilities to Next-Generation vMap Clearance Expands vMap’s Non-Invasive Mapping ...
As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...
iHealth Labs, a subsidiary of China-based medical device company Andon Health, has received FDA clearance for a wireless fingertip pulse oximeter, which will be a distinct offering from the consumer ...
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of ...
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