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When submitting a 510(k) application for non-spinal bone plates, screws and washers, sponsors may reference “previous testing experience or the literature” to demonstrate biocompatibility, provided the device is identical in composition to the reference product, the FDA said in a draft guidance released Tuesday.
An investigational artificial pancreas improved blood sugar levels in children age two to five with type 1 diabetes, researchers reported in TheNew England Journal of Medicine.
A postmarket study of a biometric chest patch and remote monitoring platform from Israel’s Biobeat Technologies showed a greater ability to identify patients with a high risk of health deterioration as compared to the standard National Early Warning Score (NEWS).
Alio, a firm focused on wireless remote patient monitoring, has received FDA clearance to add potassium, hematocrit and hemoglobin monitoring to its non-invasive SmartPatch system.
Animal studies meant to support a medical device premarket approval application should be conducted using the device in its finished form, according to a final guidance the FDA issued yesterday.
Sponsors submitting a 510(k) application for certain soft contact lenses may demonstrate substantial equivalence to previous lenses instead of having to conduct a direct comparison to a prior device, the FDA said in a final guidance released yesterday.