Ever Pharma today announced that it launched its D-mine portable micro infusion pump for Parkinson’s disease. The device recently received CE Mark approval in Europe and is now being rolled out in several European countries, according to the company. D-mine is designed to give users precise continuous subcutaneous drug delivery for Parkinson’s patients. “CE approval […]
European Commission warns on supply disruptions due to MDR, IVDR
By Stewart Eisenhart, Emergo Group A new factsheet from the European Commission advises healthcare providers and institutions to prepare for possible shortages of some medical devices and IVDs in the event that manufacturers do not meet compliance deadlines for the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story […]
Apple stores to sell One Drop glucose monitor
Apple (NSDQ:AAPL) is reportedly selling One Drop blood glucose monitors in a small number of its namesake stores in the U.S. One Drop is a compact blood glucose monitor that is compatible with the iOS Health app and the Apple Watch. The device is connected through Bluetooth and draws a small amount of blood to measure […]
Brazil ANVISA modifies custom-made medical device regulations
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA recently discussed revisions to planned requirements for custom-made devices with Emergo by UL consultants prior to finalization and official publication of the new rules. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
LRQA to withdraw European Notified Body medical device and IVD manufacturers services
By Ronald Boumans, Emergo Group UK-based Notified Body Lloyd’s Register (LRQA) plans to withdraw European Notified Body (NB) services for medical device and IVD manufacturers later in 2019. 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 […]
Syqe Medical wins regulatory approval for cannabis drug delivery device
Syqe Medical launched its pharmaceutical-grade metered-dose cannabis inhaler in Israel after a recently regulatory approval. The Tel Aviv-based pharma-tech company spent eight years researching the inhaler technology and testing it in multiple clinical trials. Syqe Medical says the drug delivery technology could introduce complex respiration technique automation, electronic selective dosing and remote clinical monitoring and […]
European regulators assign UDI issuing agencies
By Ronald Boumans, Emergo Group The European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and IVD manufacturers comply with new regulatory requirements. 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 […]
Global medical device regulatory trends
By Evangeline Loh, Emergo Group In our third global medical device regulatory update on global trends (November 2018 through May 2019), we share more updates on our previously identified themes. 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 […]
Dexcom plans Apple Watch CGM launch
Dexcom Inc. (NSDQ:DXCM) is launching upgrades for its G6 diabetes system and plans to launch its direct-to-Apple Watch version over the next year. The Apple and Dexcom collaboration would allow diabetes patients to track glucose through the Apple Watch, a consumer wearable, according to CNBC. “It’s coming,” Dexcom CEO Kevin Sayer told the network. “And […]
DHS warns again on cybersecurity flaw in BD’s Alaris infusion pump
The U.S. Homeland Security Dept. yesterday warned of two more cybersecurity vulnerabilities with the Alaris infusion pump made by Becton, Dickinson (NYSE:BDX). The DHS Industrial Control Systems Cyber Emergency Response Team, acting on weaknesses unearthed by researchers at CyberMDX, said the vulnerabilities could allow a malicious attacker to completely disable BD’s Alaris Gateway Workstation and install malware […]