Restoration Robotics has completed its ISO 13485:2016 audit and is compliant with CE Mark requirements for the sale of the ARTAS iX system with implantation in Europe.
03 Jan 2019
13 Dec 2018
PredictImmune, a developer of tools for guiding treatment options in immune-mediated inflammatory diseases, has secured CE IVD (European Conformity In-Vitro Diagnostic Medical Devices) certification for its prognostic biomarker test for IBD.
11 Dec 2018
The US Food and Drug Administration (FDA) has accepted for review Blue Earth Diagnostics' supplemental New Drug Application (sNDA) for the expanded use of Axumin (fluciclovine F 18) in adults for the detection and continuing assessment of glioma.
27 Nov 2018
Ultimaker has been certified by Materialise as a 3D printing solution to create orthopedic, maxillofacial and cardiovascular models for clinical use when used in combination with Mimics inPrint software.
21 Nov 2018
Insulet, a developer of tubeless insulin pump technology, stated that its Omnipod Insulin Management System (Omnipod System) has received (International Standards Organization) 27001 certification of its Omnipod DASH System.
08 Nov 2018
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.
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.