Vitestro’s first-of-its-kind Aletta robotic phlebotomy device draws blood autonomously from “placing the tourniquet to applying the bandage,” in the company’s words. FDA granted de novo classification for Vitestro’s Aletta system in A…

Nitinol supplier Lighteum Medical has hired Gaurav Agarwal as CEO effective Aug. 31, 2026. “Gaurav is an accomplished medtech leader and proven growth-oriented operator with a track record of building high-performing organizations and drivi…

Johnson & Johnson MedTech recently unveiled a new global standardization system to measure surgical site outcomes in The British Journal of Surgery. The new DISH Classification System outlines a consistent method for identifying and gra…

Complaint volumes have outgrown manual triage, and medical device companies are turning to AI to keep up. The speed gains are real, but used carelessly the same tools can bury a reportable event at the bottom of a queue while the MDR clock …

As healthcare shifts towards remote monitoring, connected devices and decentralized care, sensor technologies are becoming increasingly foundational to how medical devices collect, validate and transmit critical information. From remote pat…

According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving significant returns. For materiovigilance, this highlights the growing gap between execution and team expectations. …

While lot's of people wait for the 2nd version of IEC 62034, lots of other standards are being published or in the works. A few years back, IEC 62304 was alone on the scene. Then came IEC 82304-1. Now, it's raining standards. IEC 62304 2nd …

The International Medical Device Regulators Forum (IMDRF) published a draft version of their guide on artificial intelligence lifecycle management for medical devices. Introduction This document has the goal to cover the whole lifecycle of …

IEC PAS 63621 2026 - Artificial intelligence enabled medical devices - Data management, has been published in March 2026. A PAS is a Publicly Available Specification, a kind of early version of a standard. It was developed by IEC at a pace …