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Niramai’s breast cancer screening test receives CE mark approval Niramai’s breast cancer screening test receives CE mark approval 06 April 2021 | News NIRAMAI‘s Thermalytix solution can now be applied to all countries of Europe, as well as applicable to many Asian, African and Middle-East countries. Niramai, the deep-tech healthcare company at Bengaluru offering an innovative AI-based, radiation-free breast cancer screening test has now received the prestigious CE mark approval, ISO 13485 and MDSAP (Medical Device Single Audit Programme) International Certifications. T...

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 elect...

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 pro...

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.

Skip to main content Currently Reading Cirtec completes Device Master File (MAF) for their recent acquisition of the Nuvectra Algovita Spinal Cord Stimulation System PRWeb FacebookTwitterEmail 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...