By Stewart Eisenhart, Emergo Group Regulators in the US and Brazil have updated their lists of organizations approved to conduct quality system audits under the Medical Device Single Audit Program (MDSAP). 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 […]
FDA clarifies Early Feasibility Study program for innovative medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published new information online explaining how medical device manufacturers may apply and qualify for limited-scope clinical investigations known as Early Feasibility Studies (EFS). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Medtech stories we missed this week: Aug. 25, 2017
From InspireMD’s Swiss distribution deal to CoreLink’s stackable guide wire launch, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD announces Swiss distribution deal InspireMD announced in an Aug. 25 press release that it has signed an agreement with 1a Medical to distribute the CGuard EPS (Embolic […]
What FDA medical device user fee reauthorization means for registrants
By Stewart Eisenhart, Emergo Group After two years of negotiations, the US government has enacted the FDA Reauthorization Act of 2017, or FDARA, that enables the agency to continue using medical device, drug and other health product user fees as a key source of funding through 2022. Get the full story here at the Emergo […]
FDA adds UL2900 standard for medical device cybersecurity
By Stewart Eisenhart, Emergo Group US medical device regulators have officially included a new cybersecurity standard from UL to their list of recognized standards for use in premarket reviews. 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 […]
FDARA: Making a difference for industry and patients
By: Peter Marks, M.D., Ph.D., Jeffrey Shuren, M.D., J.D., and Janet Woodcock, M.D. For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon. Since passage of […]
Medtech stories we missed this week: Aug. 18, 2017
From Nemaura’s new Oceania distribution deal to Sanuwave’s promissory note expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Nemaura inks Oceania distribution deal for SugarBeat patch Nemaura announced in an Aug. 15 press release that it has signed a non-binding distribution deal with Device Technologies for […]
7 diagnostic devices to boost healthcare in the developing world
The World Health Organization estimates that a quarter of death and disease globally is caused by hazards and environmental burdens in developing countries with little to no access to preventative care and diagnostic devices. Since developing countries are poor agricultural regions that are still becoming economically and socially advanced, it is harder for doctors to […]
FDA Pre-Certification for Software program key questions and eligibility requirements
By Stewart Eisenhart, Emergo Group Following the rollout of a pre-certification pilot program for digital health technology and software developers, the US Food and Drug Administration has identified and answered several frequently asked questions regarding participation. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Medtech stories we missed this week: August 11, 2017
From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions […]