From new and renewed partnerships to FDA approvals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer System. The system uses […]
Regulatory/Compliance
23andMe is back: FDA allows marketing of genetic health risk tests
FDA this month allowed genetic testing company 23andMe to market genetic health risk tests for 10 diseases and conditions including Parkinson’s disease and late-onset Alzheimer’s disease. The de novo premarket review authorization, announced April 6, also included celiac disease, which results in the inability to digest gluten; alpha-1 antitrypsin deficiency, which raises the risk of […]
Malaysian combination product regulatory policy deadlines set
By Stewart Eisenhart, Emergo Group Malaysian medical device and drug market regulators have established a July 2018 implementation and enforcement deadline for combination product registrations marketed in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
Milestone Scientific lands marketing clearance in Saudi Arabia, Australia
Milestone Scientific (NYSE:MLSS) shares rose today after the company said it won marketing clearance in Saudi Arabia, weeks after winning a regulatory nod in Australia for its epidural and intra-articular instruments. The company’s CompuFlo Epidural instrument uses dynamic pressure sensing to help anesthesiologists correctly identify the epidural space and significantly reduce complications, according to Milestone. The […]
IMDRF wants to harmonize terminology for adverse event reporting
By Stewart Eisenhart, Emergo Group The International Medical Device Regulators Forum (IMDRF) has published a final draft of proposed terminologies for harmonized adverse event reporting for medical devices and IVDs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
10 questions companies affected by European MDR should be asking
By Ronald Boumans and Stewart Eisenhart, Emergo Group Now that the European Parliament has voted to approve the Medical Device Regulations (MDR), many medical device companies active in Europe have begun mapping out how the new Regulations will impact their business. Based on feedback from clients as well as our own analysis of the MDR, […]
China FDA getting rid of medical device testing fees
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) appears to have stopped charging substantial fees for in-country registration testing of medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com […]
European countries vie to host drug agency after Brexit
The European Medicines Agency said it has heard from 21 countries that want to host the London-based regulator once Britain leaves. The EMA is preparing to leave its headquarters as a result of Brexit and the agency’s executive director reportedly said they are hoping for a quick decision on its new location. The location will […]
Common medical device QMS problems: difficult auditees
By Stewart Eisenhart, Emergo Group Part three of our blog series on common medical device quality system audit problems examines ways to deal with difficult auditees in order to successfully obtain information and evaluate processes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Cytori wins FDA nod for cell therapy pilot trial
Cytori Therapeutics (NSDQ:CYTX) said today that the FDA approved an Investigational Device Exemption for a pilot trial of the company’s cell therapy in patients with thermal burn injury. The Relief trial is a part of Cytori’s ongoing R&D efforts under its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and […]
