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The test, which has also been cleared in Europe, is run on the company’s immunoassay analyzers, including its DxI 800 system, which can process up to 4,800 samples daily. Read More
According to the company, the Virtual Nodule Clinic is the first AI-powered decision-support software for lung cancer that has been cleared by the FDA. Read More
The noninvasive, medication-free device works by providing low-current electrical waves to the patient to relieve sinus and nasal congestion and allergy-related sinus pain. Read More
The trial is evaluating the procedure’s ability to grant durable insulin-free glycemic control in patients who aren’t getting adequate control on insulin therapy. Read More
These systems have not been shown to be accurate when used to take the temperature of multiple people at the same time and should not be used for mass temperature screening, the FDA said. Read More
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
“At this time, Team-NB is unfortunately unable to finalize and publish its aligned position on the uniform implementation of such remote audits by notified bodies,” the notified body said. 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