By Ken Modeste, Emergo Group For healthcare product and medical device technology developers, ensuring effective support for cybersecurity compliance is becoming a key step in securing regulatory approval and market access. 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 […]
Saudi Arabia regulators plan new MDMA fees, risk classification system for medical device registrants
By Stewart Eisenhart, Emergo Group Medical device market regulators in Saudi Arabia plan to raise registration fees as well as implement a new device regulatory system in the coming months. 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 […]
Eitan Group inks Canadian distribution deal for Sapphire infusion pumps
Eitan Group today announced it signed a distribution agreement with Canadian Hospital Specialities to distribute its Sapphire infusion pumps in Canada. Through the agreement, Canadian Hospital Specialties will supply and support Israel-based Eitan Group’s Sapphire infusion pumps to hospitals and alternate site customers in Canada. Get the full story on our sister site, Drug Delivery Business.
DreaMed wins clearance, CE Mark for AI-powered insulin dosing software
DreaMed Diabetes today said it received FDA 510(k) clearance and CE Mark approval for its DreaMed Advisor Pro software. DreaMed Advisor Pro is an AI-based insulin dosing decision supply software designed for people with Type 1 diabetes using insulin pump therapy with continuous glucose sensors or blood glucose meters. The software previously received CE Mark approval […]
Abbott, Medtronic ink diabetes pacts with Sanofi, Novo Nordisk
Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) today announced separate data-sharing deals for digital diabetes management solutions. Abbott is partnering with Sanofi (NYSE:SNY) to integrate glucose sensing and insulin delivery to help people manage their diabetes. The two companies plan to develop tools to combine Abbott’s FreeStyle Libre technology with insulin dosing information for smart pens, insulin titration apps and cloud software. […]
Mexico medical device import permit application process goes fully online
By Stewart Eisenhart, Emergo Group The Mexican government will begin requiring electronic submission of all import permit applications starting September 24. 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 MassDevice.com or its employees.
How the Eitan Group aims to disrupt the infusion pump industry
Privately held Eitan Group wants to bring more infusion pumps into people’s homes. Can it compete against the established players? Officials at the Eitan Group want to disrupt the infusion pump market by selling devices that are more connected and software-based — able to be used not only in hospitals but in the home. Eitan is […]
T2 Biosystems jumps on $69m BARDA deal
T2 Biosystems (NSDQ:TTOO) this week said that it inked an up to $69 million diagnostics deal with a U.S. Defense Dept. research program. Lexington, Mass.-based T2 Biosystems signed a maximum $69 million funding deal with the Health and Human Services Office of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research & Development Authority for […]
Key Brexit-related issues for medical device, IVD sectors
By Stewart Eisenhart, Emergo Group Following UK Prime Minister Boris Johnson’s recent end-run around the British Parliament to truncate debate on avoiding a no-deal Brexit, the likelihood that the UK will withdraw from the European Union without significant economic safeguards in place on October 31, 2019 appears greater than ever. Get the full story here […]
Exploring FDA approval pathways for medical devices
Lisa Wickert, Clinical Research Associate at IMARC Research, Inc. If you missed Part One of our medical device series reviewing medical device classification, please check it out here! Now that we have a grasp of the FDA medical device classification fundamentals, we can begin to explore the various pathways that a new medical device may […]
FDA clears GE Healthcare X-ray algorithms
GE Healthcare said today that it has received FDA 510(k) clearance for its AI algorithms embedded in a mobile X-ray device. The mobile X-ray device was built in collaboration with the University of California San Francisco using GE Healthcare’s Edison platform. The AI algorithms, which the company calls Critical Care Suite, are designed to reduce […]
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