Why the FDA is re-framing the regulation process for AI-based medical devices

By Anjuman Rahman

15 Apr 19

During his final days as the FDA Commissioner, Dr Scott Gottlieb revealed the the agency will consider a…

Diagnostic DevicesRegulationApprovals

World’s first social media watchdog could help tackle vaccine hesitancy

By Anjuman Rahman

09 Apr 19

Tech companies may face fines if they don't follow the new UK laws proposed to tackle misinformation causing…

Patient Care DevicesCertificationsPatient Care Monitoring

Primequal receives CE Mark for its surgical glue Talent IH

By Anjuman Rahman

03 Apr 19

Primequal claims it's the "world's first versatile adhesive applicator kit" to receive CE and provide painless mesh fixation…

ApprovalsPatient Care DevicesPatient Care Monitoring

NHS doctors improving healthcare for diabetic patients with VR medical training

By Anjuman Rahman

02 Apr 19

NHS doctors are currently using virtual reality training to be better prepared for real-life emergencies for people suffering…

RegulationApprovalsPatient Care Devices

Theresa May’s third deal rejection raises concerns over effect of Brexit on NHS

By Anjuman Rahman

01 Apr 19

The UK is preparing for a no-deal Brexit after Theresa May's third deal rejection which could result to…

RegulationApprovals

Medical devices firm recalls its needles after ‘potentially lethal’ manufacturing error

By Anjuman Rahman

28 Mar 19

The FDA said Cook Medical's needle was a class one recall after a manufacturing fault meant it "may…

RegulationApprovalsPatient Care Monitoring

BD launches new automated flow Cytometry sample preparation instrument with CE-IVD certification

By NS Medical Staff Writer

27 Mar 19

BD (Becton, Dickinson and Company), a leading global medical technology company, announced the CE-IVD certification for the BD…

RegulationCertifications

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