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. “CHS works to introduce the most advanced medical technology to […]
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 […]
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 […]
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 DrugDeliveryBusiness.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 […]
Halozyme-Genentech breast cancer pivotal meets endpoint
Halozyme Therapeutics today announced positive endpoint results from its phase III intravenous chemotherapy trial. Genentech’s FeDeriCa study used Halozyme’s Enhanze drug-delivery technology for subcutaneous administration of a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin), in combination with intravenous chemotherapy. The results showed non-inferior levels of Perjeta in the blood compared to standard IV infusion […]
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 […]
Chinese regulators publish UDI system rules for medical device registrants
By Stewart Eisenhart, Emergo Group The National Medical Products Administration (NMPA), China’s medical device market regulator, has published official Unique Device Identification (UDI) requirements that will take effect October 1. 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 […]
FDA requires more clarity on informed consent forms for clinical trials
By Stewart Eisenhart, Emergo Group A recent survey conducted by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has revealed several areas in need of improvement, according 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 […]
Phillips Medisize buys mini-tablet dispenser from Global Pharmaceutical Company
Phillips-Medisize today said that it acquired exclusive ownership of patents supporting a mini-tablet dispenser from Global Pharmaceutical Company. The mini-tablet dispenser is mounted on top of a standard tablet bottle where a patient or caregiver can count and dispense mini-tablets in predetermined amounts from one to 20 tablets. It supports tablets sized 2×2 mm to […]