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Reviewing the deficiencies cited in FDA’s Form 483s inspection reports to devicemakers, just five areas account for almost 25 percent of all the observations by agency investigators each year. Read More
An FDA inspection of Apneicare’s medical device facility in Columbus, Ohio, turned up several repeat observations, including problems with handling complaints, completing corrective action reports and updating product labeling. Read More
The FDA has deemed the Oct. 27 recall by Teleflex and subsidiary Arrow International of two central venous catheter kits as Class 1 because of the risk of serious injury or death. Read More
Oxford BioDynamics’ EpiSwitch blood biomarker assay for amyotrophic lateral sclerosis (ALS) showed which patients were likely to have a fast or slow progressing disease, the company said, citing interim results from a multicenter trial.
Pfizer has entered into a multi-year deal with Anumana — a joint venture between the Mayo Clinic and nference, an electronic health record data company — to develop software for early detection of cardiac amyloidosis.
Guardant Health’s investigational blood test to detect colorectal cancer in average-risk adults showed promising results in a 20,000-participant study evaluating what would be the first blood test available in the U.S. to scan for colorectal cancer.