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Among other uses, the noninvasive monitoring device can reduce rapid response team activations, intensive care unit transfers and the cost of care, the company claims. Read More
The antigen test is validated to detect all “variants of concern” of the coronavirus that causes COVID-19, including the highly transmissible Delta variant. Read More
The improved software analyzes information from multiple computed tomography scans after the first cycle to calculate the dose for the remaining cycles. Read More
As of Aug. 31, there had been at least 66 infections, including 60 bloodstream infections, associated with these affected products, the agency said. Read More
The European Commission (EC) is still looking into whether Illumina’s decision to complete its $8 billion acquisition of Grail is in breach of EU merger regulations. Read More
Failure to file a medical device report within 30 days and to establish adequate procedures for corrective and preventive actions (CAPAs) were among the quality system deviations the FDA discovered during a March 16 to May 4 inspection of Myerson’s Chicago, Illinois facility. Read More
Failure to validate its products or to establish procedures that demonstrate its acupressure bracelets for nausea were manufactured according to specifications were among the 13 quality system lapses observed during a March 29 to April 1 FDA inspection of MumEase’s Charlotte, North Carolina facility. Read More
The FDA said it was proposing to refuse Intarcia Therapeutics’ drug-device combination product, ITCA 650, for continuous release of the type II diabetes drug exanatide. Read More