News and Notes

The FDA’s MDDT program qualifies select, scientifically validated tools for use in medical device development and evaluation, enabling sponsors to generate reliable, FDA accepted data in clinical investigations.

Ultraviolet Devices Inc. (UVDI), a developer of advanced ultraviolet disinfection technology, has launched its new V-MIX upper-room air disinfection technology and it will be featured at the AHR Expo in Las Vegas.

The new report aims to understand the implications that technologies such as GenAI may have on the nursing workforce in relieving some of these pain points and what nurses think about the rollout of new solutions.

AccurKardia, an ECG-led diagnostics software company focused on transforming ECG data into a more powerful diagnostic tool and broad biomarker to improve patient outcomes and save lives, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of its AccurECG Analysis System (v2.0) (K252361). AccurECG 2.0 builds on AccurKardia’s previously FDA-cleared AccurECG platform, representing the next-generation evolution of the company’s enterprise-grade ECG interpretation system. With this milestone, the AccurECG platform has now secured two separate FDA 510(k) clearances.

Mölnlycke Health Care, a global leader in MedTech, headquartered in Gothenburg, Sweden, is celebrating the production of 100 million ProcedurePak trays at the company’s production sites in the Czech Republic.