Cytori receives approval in Japan for Celution cell therapy system

By NS Medical Staff Writer

04 Dec 18

Cytori Therapeutics has received Class III medical device approval in Japan for the Celution cell therapy system.

RegulationApprovals

Aziyo secures FDA nod for expanded use of CanGaroo Envelope with neurostimulator devices

By NS Medical Staff Writer

30 Nov 18

Aziyo Biologics has secured the US Food and Drug Administration (FDA) clearance for its CanGaroo Envelope device, to…

RegulationApprovals

Quidel secures CE Mark for TriageTrue high sensitivity troponin I test

By NS Medical Staff Writer

30 Nov 18

Quidel has received CE Mark for TriageTrue high sensitivity troponin I test, the next-generation diagnostic assay for aid…

RegulationApprovals

Amsel Medical receives third 510(k) clearance for occluder devices

By NS Medical Staff Writer

29 Nov 18

Amsel Medical has secured 510(k) pre-marketing notification from the US Food and Drug Administration (FDA) for its Amsel…

RegulationApprovals

Invivoscribe submits LeukoStrat CDx FLT3 assay in US, Japan as companion diagnostic for quizartinib

By NS Medical Staff Writer

28 Nov 18

Invivoscribe has submitted LeukoStrat CDx FLT3 mutation assay to both the US FDA and the Japan Pharmaceuticals and…

RegulationRegulatory Policy

FDA plans to overhaul 510(k) approval process for medical devices

By NS Medical Staff Writer

28 Nov 18

The US Food and Drug Administration (FDA) is planning to overhaul the framework for evaluating the safety and…

RegulationRegulatory Policy

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

Genentech gets FDA nod for autoinjector formulation of Actemra

By NS Medical Staff Writer

27 Nov 18

The US Food and Drug Administration (FDA) has approved the ACTPen for Genentech’s Actemra, a single-dose, prefilled autoinjector…

RegulationApprovals

Colombian authority completes review of Hancock Jaffe’s application for VenoValve trial

By NS Medical Staff Writer

22 Nov 18

Colombia’s INVIMA, the country’s FDA equivalent, completed the review of Hancock Jaffe Laboratories' application for a first-in-human trial…

RegulationApprovals

Health Canada approves IMBiotechnologies’ new biodegradable embolic agent

By NS Medical Staff Writer

22 Nov 18

IMBiotechnologies has secured approval from Heath Canada for its Ekobi cmbolization microspheres to treat hypervascularized tumors (HVT) and…

RegulationApprovals