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The sensor operates continuously for two weeks, making it “the longest-lasting, self-applied continuous glucose-monitoring sensor available,” Abbott said. Read More
The agency said it “generally does not seek to interfere with the exercise of the professional judgment of healthcare providers in prescribing or using, for unapproved uses for individual patients, most legally marketed medical products.” Read More
A manufacturer that uses an ASCA-accredited testing lab can include a declaration of conformity from the accredited lab as part of a premarket submission to the FDA. Read More
“The CE mark allows us to support many more clinical labs and organizations globally, including those performing COVID-19 testing during the current pandemic,” the company said. Read More
The FDA found Anodyne Therapy’s validation and risk analyses were inadequate, and reports of radiation were not sent to the FDA, according to a 483 the firm received follow an agency inspection of its Oldsmar, Florida facility. Read More
The Government Accountability Office (GAO) has proposed that the FDA’s medical device, drug evaluation, and biologics evaluation centers implement formal equipment management policies after finding that their current procedures need improvement. Read More