MedTech News
.................... by Andrew Celentano

Waters Secures FDA Clearance for BD BACTEC FXI Blood Culture System
The automated system is now available in the US, offering faster bloodstream infection detection and higher vial-loading capacity for high-throughput microbiology laboratories.

Clarius Receives FDA Clearance for AI-Based Ejection Fraction Ultrasound Tool
The app-integrated tool automates left ventricular ejection fraction assessment, supporting real-time cardiac evaluation in primary care and emergency settings.
UNM Surgeon Introduces Advanced Thumb Joint Replacement Procedure for Arthritis Patients
The procedure is comparable to hip and knee replacement surgeries, where a prosthetic implant is used to replace damaged joint surfaces

Medtronic wins FDA clearance for Nellcor pulse oximetry system with intelligent processor
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its Nellcor pulse oximetry system with the Nell-EQ intelligent processor.

Medtronic earns CE mark for Stealth AXiS robot platform in ENT surgery
Medtronic (NYSE:MDT) today announced the receipt of CE mark approval for its Stealth AXiS surgical system for ENT procedures.

Engineered stem cells reverse new-onset type 1 diabetes in mice
A group of researchers at the Medical University of South Carolina (MUSC) has recently developed a new stem cell therapy with a remarkable ability to reverse new-onset type 1 diabetes (T1D) in a mouse model of the disease. The work is published in the journal Molecular Therapy.

AI-designed universal vaccine clears first human trial, targets future coronavirus threats with needle-free delivery
The first human clinical trial of a universal Sarbeco coronavirus vaccine, developed by the University of Cambridge and spin-out DIOSynVax (DVX) Ltd, has shown that the vaccine is safe and has no significant side effects.

First AI-designed ‘universal vaccine’ tested in humans: UK researchers
The new vaccine aims to produce an immune response that will protect against many pathogens—including some circulating among wild animals that might jump into humans in the future.