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“In addition to reducing existing acne, clinical trials show that future breakout episodes are shorter, less intense, and more infrequent following the AviClear procedure,” the company says. Read More
The agency said NeuroOne may re-submit a new 510(k) application if it has biocompatibility data to show its device to be substantially equivalent. Read More
The company is planning a limited U.S. market release of the 027 micro-catheters in the second quarter of this year, with the 021 micro-catheters platform to follow shortly afterwards. Read More
The test provides qualitative detection of RNA from the SARS-CoV-2 virus in nasopharyngeal and nasal swab specimens with RT-PCR in 17 minutes or less. Read More
The camera is compatible with the kinds of patient data consoles, surgical displays and endoscopes found in minimally invasive operating rooms. Read More
Analysis of the tests is limited to laboratories designated by Quest Diagnostics that meet the requirements to perform high-complexity tests. Read More