Boston Scientific has been granted FDA 510(k) clearance for their LUX-Dx insertable cardiac monitor system. This long-term diagnostic device is used to detect arrhythmias from conditions such as atria...Read More
Beckman Coulter has been granted Emergency Use Authorization by the FDA for its new COVID-19 antibody test. This approval comes after being tested by the top four in vitro diagnostic manufacturers in ...Read More
The most recent integrated continuous glucose monitor (iCGM) from Abbott, the Freestyle Libre 2, has been granted FDA approval for sale in the U.S. to adults and children over the age of four with dia...Read More
Bardy Diagnostics‘ 14-day Carnation Ambulatory Monitor (CAM) patches have previously been used in U.S. hospital settings, but they have now been granted a CE mark for these products. The patches...Read More
The FDA has recently granted clearance for the portable AiRTouch X-ray device developed by Aspenstate to be used for humans. This small, handheld device joins the array of telehealth products being de...Read More
The FDA has recently granted 510(k) clearance to Philips for a range of its devices to be used to manage COVID-19 patients in the U.S. The approved products include the Affiniti series, EPIQ series, L...Read More
In Europe, respiratory device manufacturer ResMed has accelerated their process of launching remote tracking of ventilators, to combat the ongoing COVID-19 crisis. This cloud-based technology provides...Read More
BioIntelliSense has created a multi-symptom tracking device called the BioButton to conveniently measure health metrics, as part of the ongoing efforts to track and control the spread of COVID-19. Thi...Read More
A new device has been developed to measure physical symptoms in COVID-19 patients. This non-invasive device allows medical personnel to monitor a variety of symptoms with a singular device. This throa...Read More
Bardy Diagnostics‘ Carnation Ambulatory Monitor (CAM™) Patch is being used by Seattle health care workers to monitor heart beat and measure QT segments in coronavirus patients prescribed HCQ e...Read More