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The FDA’s Office or Regulatory Programs has sent letters to 25 manufacturers, distributors and sellers telling them to stop producing and issuing these certificates. Read More
The analyzer can perform up to 870 tests per hour and run Roche’s full offering of diagnostic tests for infectious diseases, oncology and cardiology. Read More
With the agency’s first full approval for a COVID-19 diagnostic, tests of the same type may now go through its 510(k) pathway for potential clearance. Read More
The software produces a “likelihood of malignancy” finding that aligns with the American College of Radiology’s BI-RADS rating scale and Europe’s five-point rating system. Read More
It is made of nontapered metal-alloy and polymer that helps it better handle tough calcium and plaque found in late-stage peripheral artery disease and critical limb ischemia patients. Read More