Exalenz Bioscience has received FDA clearance for its BreathID Hp point-of-care system and BreathID Hp lab system for use in detecting Helicobacter pylori bacteria in children aged 3 to 17 years.
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The settlement resolves allegations that Alere caused hospitals to submit false claims to Medicare, Medicaid, and other federal healthcare programs by knowingly selling materially unreliable point-of-care diagnostic testing devices.
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Comparable in size to a cell phone, the Vitals360 device is the first telehealth instrument that can be used for both point-of-care and remote patient monitoring.
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Siemens Healthineers has received FDA premarket notification clearance for its blood urea nitrogen and total carbon dioxide point-of-care tests to aid in the diagnosis of renal diseases and metabolic imbalances.
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MeMed has been awarded a grant from the Department of Defense’s congressionally directed medical research programs to support the transition of its prototype point-of-care platform into a final product.
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