Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, August 16, 2023.
People living with diabetes are always looking for ways to make the management of their chronic condition easier. Welldoc aims to address that with its BlueStar platform, which just received its 10th FDA clearance, this time for using connected insulin dosing data in personalized bolus insulin dosing recommendations. Fast Five hosts Sean Whooley and Danielle Kirsh break down what BlueStar does and how this latest regulatory nod boosts Welldoc.
The episode also covers FDA authorization for another innovative technology — Viz.ai’s artificial intelligence-based module for detecting hypertrophic cardiomyopathy. The FDA’s de novo nod creates a new regulatory category for cardiovascular machine learning-based notification software. Learn about how this module works as another AI-based technology garners regulatory approval.
Meanwhile, Viseon says it began the U.S. commercial rollout and initial clinical use of its MaxView 4K advanced visualization system. The company describes MaxView 4K system as a first-of-its-kind advanced visualization system for minimally invasive spine surgery. Hear about what this technology does that makes surgeons call it a “game-changer.”
Microbot Medical, maker of the Liberty surgical robot, entered into a manufacturing deal with B.Y. Medimor. This could prove a significant milestone as the company looks to garner regulatory approvals for its robot before a commercial rollout. Find out more about what the robot does and how Microbot is looking at the next steps.
The FDA revealed another Class I recall — the most serious kind — for ventilators made by Philips Respironics. This one, while unrelated to the recall that knocked the company out of the sleep respiratory market more than two years ago, still led to some serious outcomes, including injuries and a death. Learn more about what caused this recall and how many people it’s affected in the U.S. to date.
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