Plymouth, Minn.-based Nonin Medical Inc. gained a U.S. FDA 510(k) clearance for its Co-Pilot wireless hand-held multiparameter system (H500). The system is expected to be used by first responders to evaluate various oxygenation and respiratory-related parameters in patients after incidents such as cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.
The U.S. FDA’s priorities for testing for the SARS-CoV-2 virus have shifted as circumstances have changed, and the agency is putting more emphasis into testing of pooled samples. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the July 8 diagnostic town hall that the agency wants to encourage test developers to work on their existing EUAs for pooled sampling.
Reflexion Medical Inc. appears to be on a roll. A little more than a month after unveiling a tie up with Merck & Co. Inc., it now has reported a collaboration with Telix Pharmaceuticals Ltd., a radiopharmaceutical company developing molecularly targeted radiation products.
RapidAI, which focuses on imaging for stroke, has received the U.S. FDA’s nod for Rapid ASPECTS. According to the company, it is the first neuroimaging analysis device to gain clearance in the computer-assisted diagnostic software category.
Research focused on finding viable solutions to counter the COVID-19 pandemic continues at an explosive pace with a total of 588 potential therapeutics and vaccines at the forefront of scientific efforts launched by industry, academia and government.
Research focused on finding viable solutions to counter the COVID-19 pandemic continues at an explosive pace with a total of 588 potential therapeutics and vaccines at the forefront of scientific efforts launched by industry, academia and government.
Keeping you up to date on recent developments in diagnostics, including: Broad scale genomic testing for childhood illness; Deep learning model for cancer prognosis; Placenta attachment theory.
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