By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have approved plans to amend registration requirements for low-risk devices to more closely align with International Medical Device Regulators Forum (IMDRF) recommendations. 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 […]
7 medtech stories we missed this week: May 11, 2018
From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau […]
FDA clarifies multiple-function medical device oversight policy
By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration addresses premarket authorization requirements for multiple-function products with at least one function that qualifies as a medical device. 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 […]
Does your Trial Master File tell the right story about your study?
Brandy Chittester, Chief of Clinical Operations, IMARC In clinical research, we often say “If it’s not documented, it’s not done.” Throughout a clinical trial, this adage guides decision-making processes when securing compliance. If a study team member was no longer working on the study, would the rest of the team know what happened well enough […]
Alcon launches project to reduce cataract blindness
Alcon, a division of Novartis, launched its Alcon Cares Project 100 to take steps in reducing cataract blindness globally. The company also plans to donate 100 reprocessed Infiniti units to eligible clinics in Asia, Central and South America and Africa over the next three years. Alcon aims to reduce cataract blindness by providing equipment to […]
Medical device recalls significantly increase during Q1
The medical device and pharmaceutical industries saw a significant spike in product recalls during the first quarter of 2018, according to the U.S. Recall Index released by Stericycle Expert Solutions. There was a 126% increase in medical device recalls in Q1 — the most in a quarter since 2005. Software problems made up about 22.7% […]
Why con-meds are important
Christian Barille, Clinical Research Associate, IMARC Concomitant medications (con-meds) are any prescription or over-the-counter drugs and supplements taken in addition to an investigational therapy by a study subject. Many study protocols require capturing con-med usage into subject’s study record. This can be an extremely difficult task as it relies on the honest and accurate reporting […]
7 medtech stories we missed this week: April 27, 2018
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 […]
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 […]
How 3D printed cells on the skin could enable wound healing
Researchers at the University of Minnesota are 3D printing electronics and cells directly on the skin that could create new methods for wound healing and enable biological agent detection. The Minnesota researchers used a customized, low-cost 3D printer to print electronics on a human hand. They’ve also successfully printed biological cells on a sin wound of […]
5 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 […]