Alkermes secures FDA approval for Aristada Initio to treart schizophrenia

By NS Medical Staff Writer

04 Jul 18

Alkermes has secured the US Food and Drug Administration (FDA) approval for its Aristada Initio (aripiprazole lauroxil) for…

RegulationApprovals

FDA approves Shape Memory Medical’s Impede embolization plug

By NS Medical Staff Writer

27 Jun 18

Shape Memory Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Impede…

RegulationApprovals

LumiThera’s LT-300 secures CE Mark to treat AMD

By NS Medical Staff Writer

25 Jun 18

LumiThera has secured CE Mark Certification for its LT-300 Light Delivery System for the treatment of dry age-related…

RegulationCertifications

FDA approves Optovue’s OCTA blood vessel measurement technology

By NS Medical Staff Writer

12 Jun 18

Medical device firm Optovue has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its…

Diagnostic ImagingApprovalsDiagnostic Devices

Corindus’ CorPath GRX robotic-assisted PCI system gets Japan approval

By NS Medical Staff Writer

11 Jun 18

Corindus Vascular Robotics’ robotic-assisted percutaneous coronary interventions (PCI) system CorPath GRX has been approved by the Pharmaceutical and…

RegulationApprovals

FDA approves Centinel Spine’s FLX platform of 3D printed all-titanium interbodies

By NS Medical Staff Writer

08 Jun 18

The US Food and Drug Administration (FDA) has approved Centinel Spine's FLX platform of Integrated Interbody and non-integrated…

RegulationApprovals

FDA approves Insulet’s Omnipod DASH insulin management system

By BV Swagath

05 Jun 18

Insulet has bagged FDA 510(k) clearance for its Bluetooth wireless technology-based Omnipod DASH insulin management system in the…

RegulationApprovals

Zealand Pharma completes second phase 3 trial of dasiglucagon to treat severe hypoglycemia

By NS Medical Staff Writer

29 May 18

Biotechnology firm Zealand Pharma has completed the second phase 3 trial with dasiglucagon for the treatment of severe…

Patient Care DevicesRegulationPatient Care Monitoring

DNV Nemko Presafe acquires DGM

By murthyvittala

21 Dec 12

By acquiring DGM, Presafe will significantly strengthen its position in the area of certification services for the medical…

Regulation

DNV Business Assurance and Nemko join forces to establish DNV Nemko Presafe

By murthyvittala

21 Dec 12

The two global certification bodies DNV Business Assurance and Nemko announce the merger of their certification and testing…

Regulation