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The company said that approximately 1 percent of the test strips in 24 lots distributed in Europe have been affected by the manufacturing issue. Read More
Concerns about the use of paclitaxel-coated balloons surfaced following a December 2018 study that warned against treating patients with peripheral arterial disease. Read More
The agency is not currently recommending that any STAR implants be removed, saying it is still appropriate for certain patients, such as older patients who are less active. Read More
Users running the test should keep an eye out for unexpected clusters of positive Flu B results, which may indicate a tube leak, and repeat tests when two or three analytes are positive, as different results on the repeat test could indicate abnormal PCR cycling. Read More
The FDA issued an alert about thermal imaging systems intended to measure human body temperature because improper use of these systems may provide inaccurate temperature readings. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that paclitaxel drug-coated balloons or drug-eluting stents should not be used in the routine treatment of patients with widening of the arteries, as the mortality risk generally outweighs the benefits. Read More
The single-arm study will span at least 50 sites in Europe, Asia and South America, and will involve patient follow-up at 30 days, six months, then every year for five years. Read More
Healthcare providers that used the test and suspect a recent inaccurate result should consider retesting patients with a different COVID-19 test, the agency said. Read More
The reported failures included ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the catheter’s distal-tip region. Read More
While there have been no reported deaths, there have been 57 complaints and 14 reports of serious injuries stemming from the issue, the FDA said. Read More