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The app, which connects to a variety of insulin pumps and continuous glucose monitoring systems, is expected to be available later this year. Read More
The upgraded system offers a number of new features, including enhanced patient file management and report generation with image comparisons, Kent said. Read More
Cardiac CT combined with SQuEEZ analysis software “can provide clinicians with a normalized measurement to determine … [if] contractile function [is] normal or not normal,” the company said. Read More
The FDA has issued a final guidance recommending that devicemakers include more specific information in the labeling of laparoscopic power morcellators (LPMs) on the risk of spreading benign uterine tissue and on the use of LPM containment systems. Read More
FDA investigators observed problems with equipment calibration, validation studies and design verifications among other failings during inspections of five device manufacturing facilities. Read More
The European Commission (EC) launched a new registration module in December for Eudamed, the EU database that will be used to monitor the safety and performance of devices under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Read More
The UK and the European Union wrapped up a landmark trade deal on Dec. 24 — just days before the UK completed its transition out of the EU. Although not specifically targeted at medical devices, the pact acknowledges existing arrangements for devices. Read More
The FDA issued 16 warning letters in 2020 related to COVID-19 diagnostic tests, most of them marketed directly to consumers, and the agency said it will continue targeting those this year. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Read More