TUV Rheinland OpenSky has helped Insulet’s Omnipod DASH insulin management system to be the first FDA-cleared insulin pump to achieve certification under the Diabetes Technology Society’s cybersecurity assurance standard and program, known as DTSec.
08 Nov 2018
01 Nov 2018
Cerus, a biomedical products company focused in the field of blood transfusion safety, has received the US Food and Drug Administration (FDA) breakthrough device designation for pathogen-reduced cryoprecipitate product candidate.
30 Oct 2018
American mobile health company Aptatek BioSciences has received breakthrough device designation from the US FDA Center for Devices and Radiological Health (CDRH) for its phenylketonuria (PKU) test system, which allows real time monitoring of blood phenylalanine levels by PKU patients.
05 Oct 2018
Sensera said that it is now certified to the ISO 13485:2016 quality standard. ISO 13485:2016 specifies requirements for a quality management system, associated to medical devices.
20 Sep 2018
Oxford University spin-off Oxehealth has secured accreditation from the British Standards Institute (BSI) for its vital signs measurement software as a Class IIa medical device in Europe.
19 Sep 2018
World Technology (WCOR) has secured CE Class 1 Medical Device Certification from the Ministry of Health in Italy for its non-invasive blood sugar monitoring device, Helo Extense.
25 Jun 2018