From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed to […]
Eudamed completes actors module testing
By Ronald Boumans, Emergo Group On April 12, 2018, 20 representatives of stakeholders from industry and European Competent Authorities (CAs) had the opportunity to test the first Eudamed module. This module will be used for entering actor data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Polyplastics copolymer used in Tandem wearable insulin pumps
Polyplastics‘s Topas 8007S-0$ cyclic olefin copolymer (COC) is now being used in Tandem Diabetes Care‘s insulin delivery pumps. The Tandem t:slim X2 Insulin Pump is one of the smallest pumps on the market. It is a continuous glucose monitor-enabled pump that lets users make decisions about their treatment without having to prick their finger to […]
Medtech stories we missed this week: April 20, 2018
From CHF Solutions’ new Italian distribution deal to Masimo’s CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. CHF Solutions signs Italian distribution deal CHF Solutions announced in an April 17 press release that it has signed a new distribution agreement with TRX Italy to distribute […]
Health Canada launching new unit for digital health technology licensing
By Stewart Eisenhart, Emergo Group Medical device regulators at Health Canada are developing a more targeted oversight approach for digital health technologies such as mobile medical applications. 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 […]
What Brexit withdrawal means for MDR implementation in the U.K.
By Ronald Boumans, Emergo Group Negotiators discussing how the UK will leave the European Union have reached a draft Withdrawal Agreement about the transition period. The transition will start on March 29, 2019 and will end on December 31, 2020. Instead of 12 months from now, there are 21 months to prepare. This is still […]
Medtech stories we missed this week: April 6, 2018
From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning. 1. CHF inks Spanish distribution deal CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow […]
HFES conference to host workshop on risk analysis for summative usability tests
By Kate Jablonski, Emergo Group A workshop session at the 2018 International Symposium on Human Factors and Ergonomics in Health Care will provide insights into conducting residual risk analyses for summative usability tests for medical devices. 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: March 23, 2018
From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with Innovasource. […]
China CFDA proposes regulatory framework for 3D-printed medical devices
By Stewart Eisenhart, Emergo Group Medical device market regulators at the China Food and Drug Administration (CFDA) have published new guidance proposing registration requirements for devices produced via 3D printing or additive manufacturing. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]