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Medical diagnostic test developer Cleveland Diagnostics has received a Form 483 for deficiencies observed during an FDA inspection of the company’s facility in Cleveland, Ohio, last November. Read More
The best way for Congress to help the FDA address its concerns about reports of a high level of false-positive results from noninvasive prenatal testing (NIPT) is to pass new legislation, the FDA said in a Feb. 11 letter to lawmakers. Read More
According to AdvaMed, the diagnostics industry has shipped approximately 800 million COVID-19 tests to laboratories across the country since March 2020, as well as more than 1 billion at-home tests. Read More
San Francisco, Calif.-based Sirona Medical has acquired two FDA-cleared products from Nines, another California radiology software developer, expanding its portfolio of products that use artificial intelligence (AI) for analysis of radiographic images. Read More
The FDA has released its long-awaited proposed rule that aims to harmonize the agency’s Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485 standard. Read More
The company expects the diagnostic tests to be in high demand in Europe, where most of the molecular testing is performed in decentralized hospital settings. Read More