bioLytical earns highest quality standard in medical device industry

By NS Medical Staff Writer

22 Feb 19

bioLytical Laboratories, a developer and manufacturer of rapid infectious disease tests, has successfully earned a certificate for conformance…

RegulationCertifications

Abiomed gets CE mark for Impella Connect cloud-based monitoring platform

By NS Medical Staff Writer

01 Feb 19

Medical devices maker Abiomed has secured CE mark approval for its Impella Connect cloud-based monitoring platform.

RegulationCertifications

Restoration Robotics secures ISO 13485:2016 certification

By NS Medical Staff Writer

03 Jan 19

Restoration Robotics has completed its ISO 13485:2016 audit and is compliant with CE Mark requirements for the sale…

RegulationCertifications

PredictImmune to launch PredictSURE IBD biomaker test in UK and Europe

By NS Medical Staff Writer

13 Dec 18

PredictImmune, a developer of tools for guiding treatment options in immune-mediated inflammatory diseases, has secured CE IVD (European…

RegulationCertifications

FDA accepts Blue Earth Diagnostics’ sNDA for 18F-fluciclovine PET Imaging in Glioma

By NS Medical Staff Writer

11 Dec 18

The US Food and Drug Administration (FDA) has accepted for review Blue Earth Diagnostics' supplemental New Drug Application…

RegulationCertifications

Materialise certifies Ultimaker S5 as 3D printing solution

By NS Medical Staff Writer

27 Nov 18

Ultimaker has been certified by Materialise as a 3D printing solution to create orthopedic, maxillofacial and cardiovascular models…

RegulationCertifications

Insulet’s Omnipod DASH system receives ISO 27001 Certification for information security

By NS Medical Staff Writer

21 Nov 18

Insulet, a developer of tubeless insulin pump technology, stated that its Omnipod Insulin Management System (Omnipod System) has…

RegulationCertifications

TUV Rheinland helps Insulet’s insulin pump secure cybersecurity certification by DTSec

By NS Medical Staff Writer

08 Nov 18

TUV Rheinland OpenSky has helped Insulet’s Omnipod DASH insulin management system to be the first FDA-cleared insulin pump…

RegulationCertifications

Cerus secures FDA breakthrough device status for pathogen-reduced cryoprecipitate

By NS Medical Staff Writer

01 Nov 18

Cerus, a biomedical products company focused in the field of blood transfusion safety, has received the US Food…

RegulationCertifications

Aptatek PKU home-based test system gets FDA breakthrough device designation

By NS Medical Staff Writer

30 Oct 18

American mobile health company Aptatek BioSciences has received breakthrough device designation from the US FDA Center for Devices…

RegulationCertifications