From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. […]
Conducting clinical research in medical device studies using a quality systems approach
FDA is encouraging a quality systems approach to conducting clinical trials. The Clinical Trials Transformation Initiative (CTTI) established the Quality by Design initiative for clinical research. Patients and those who care for them want access to new drugs, devices, and biological products as quickly as possible, while also being assured that the benefits of these […]
Brazilian regulators propose easier market pathway for low-risk medical devices and IVDs
By Stewart Eisenhart, Emergo Group Medical device and IVD regulators in Brazil plan to loosen market access for low-risk devices and IVDs by introducing a notification-only registration system for these products. 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 […]
PIP breast implant scandal: A story that triggered change
In the healthcare industry, stories of patient harm can sometimes be the impetus for positive change. This was the case with the PIP breast implant scandal, where cost-cutting decisions that resulted in injuries eventually led to major regulatory updates. In 1965, plastic surgeon Henri Arion introduced breast implants to France. Jean-Claude Mas, a former butcher […]
Pros and cons of MDNR and MDMA medical device registration in Saudi Arabia
By Stewart Eisenhart, Emergo Group Now that Saudi Arabian medical device regulators have exempted some low-risk products from full registration requirements, qualifying manufacturers should consider whether standard or fast-track access to the Saudi market best suits their business needs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
Value-based care: CMS’s new administrator wants more of it
Seven months into her tenure, CMS administrator Seema Verma is turning out to be highly supportive of value-based care models. In fact, she recently told an audience in Cleveland that she wants them implemented faster. The situation appears to dispel doubts that alternative payment models – such as Accountable Care Organizations or “comprehensive care” models for […]
FDA’s role in medical device cybersecurity
By: Suzanne Schwartz, M.D., M.B.A. Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in can be vulnerable to security breaches. A computer virus or hack resulting in the loss […]
7 medtech stories we missed this week: Nov. 3, 2017
From Hologic’s new product launch to CapsoVision gettting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Hologic launches new MyoSure device Hologic announced in a Nov. 1 press release that it has launched its MyoSure Manual Device in the U.S. The device is designed […]
FDA issues final guidance on medical device changes that need new 510(k) submissions
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]
9 exhibitors to check out at MD&M Minneapolis
MD&M Minneapolis is an event that brings together more than 5,500 medtech professionals and more than 600 suppliers together at one of the largest medical device industry hubs in the United States. Here are nine exhibitors showcasing some of their latest technologies and services at the show, which takes place Nov. 8–9 at the Minneapolis […]
Final rule for clinical trials registration and results submission
Clinicaltrials.gov is a database of clinical research trials being conducted both in the U.S. and internationally and is intended to be a resource for patients and researchers alike. Housed by the United States National Library of Medicine, clinicaltrials.gov currently has postings for over 257,000 clinical studies that are being conducted in over 200 countries. On […]