Mar 10, 2021 11:21am Following years of development as a wearable for other infectious respiratory diseases, Empatica s Aura device has been called up to help detect outbreaks of COVID-19. (Empatica)
The makers of a wearable device designed to automatically detect epileptic seizures and call for help have their eyes set on COVID-19 with a newly obtained approval in Europe for a device that detects respiratory infections before symptoms appear.
Empatica’s wrist-worn Aura system passively collects data from the wearer, including on their heart rate, pulse variability and the electrical activity of their skin, to spot the small changes that occur when the body’s immune system is fighting off a viral intruder.
Feb 12, 2021 11:35am To evaluate the test’s accuracy against new coronavirus mutations, BD used computer modeling to show that 99.9% of the altered genetic sequences would still match up to the targets used in its tests. (Getty/RossHelen)
BD has secured U.S. and European authorizations for a new COVID-19 test that screens for the coronavirus as well as influenza A and B and the company said it’s shown to work against the emerging variants first identified in the U.K. and South Africa.
The molecular laboratory test is designed to turn around results in two to three hours, and process hundreds of samples per day on the company’s BD MAX platform.
From taste and smell to muscle aches and “COVID toes,” the coronavirus affects the body in a variety of ways including small changes in a person’s voice, subtle to the ear but clear enough to spot on a computer, according to Vocalis Health.
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Cirtec completes Device Master File (MAF) for their recent acquisition of the Nuvectra Algovita Spinal Cord Stimulation System
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MINNEAPOLIS (PRWEB) February 01, 2021
Cirtec Medical Corporation, a strategic outsourcing partner for complex medical devices including active implantables, minimally invasive devices and novel catheter-based delivery systems, today announced a sponsor-initiated withdrawal of the premarket approval (PMA) for the Nuvectra Algovita Spinal Cord Stimulation System. The System was an FDA and CE Mark approved neurostimulation system with no open field actions at the time of acquisition. The withdrawal of the PMA and subsequent creation of the Device Master File aligns with Cirtec’s strategy to support Academic, Research and Commercial partners with design, development, and manufacturing of active implantable device.
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