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QuadM Technologies received a Form 483 from the FDA after an inspection of its Hamilton, N.J., facility in April that highlighted a variety of documentation issues. Read More
Failure to ensure that its medical devices met regulatory and other requirements landed Health Care Technology (HCT) a Form 483 from the FDA following an inspection at its Ashland, Mass. facility in April. Read More
The Department of Justice (DOJ) has launched a nationwide law enforcement action against fraudulent billing for cardiovascular and cancer genetic tests and medical devices. Read More
The FDA has granted Breakthrough Device designation to Roche’s Elecsys Amyloid Plasma Panel, a minimally invasive test for early diagnosis of Alzheimer’s through blood biomarkers, which could become the first FDA-approved test for this disease. Read More
Currently, less than 0.2 percent of adults with obesity are treated surgically for obesity, leaving a substantial unmet need, the company said. Read More