PERTH, Australia – See-Mode Technologies has received 510(k) clearance from the U.S. FDA to market its Augmented Vascular Analysis (AVA) program that uses artificial intelligence (AI) to analyze vascular ultrasound scans to better predict stroke. Caused by plaque that ruptures in blood vessels and blocks blood flow to the brain, stroke affects roughly 15 million people per year and is the second-leading cause of death globally.
The U.S. FDA cleared Ezra AI Inc.'s artificial intelligence (AI) system for prostate cancer and its cloud-based picture archiving and communication system (PACS) that enables radiologists to use the Prostate AI from their browser. The New York-based company’s Prostate AI is the first prostate-focused artificial intelligence system to gain clearance. The Prostate AI accurately quantifies prostate volume, lesion size, and renders 3D volumes of the prostate gland and lesions.
Medtronic plc reported 12-month data from a large, multicenter, randomized controlled clinical trial affirming the superiority of differential target multiplexed spinal cord stimulation (DTM SCS) in relieving chronic back pain, vs. traditional SCS therapy, using its Intellis platform.
The U.S. FDA’s device center has declared it will not review emergency use authorization (EUA) requests for lab-developed tests (LDTs) for the COVID-19 pandemic, but on the agency’s most recent town hall, on Oct. 14, FDA officials were uncertain as to whether labs should file those EUAs, leaving labs in a state of limbo yet again.
NEW DELHI – Indian health care technology startups have gained ‘significant momentum’ over the last five years, fueled by a government push towards digitization, the uptake of technological advances and a spurt in health care apps. “The Indian health tech startup landscape has now come of age and includes a robust pipeline of ventures across both ends of the spectrum,” Sathguru director Pushpa Vijayaraghavan told BioWorld.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIST ramps up Zero Trust cybersecurity program; TGA sets date for mesh up-classification; IMDRF posts post-market study update; ANVISA updates list of non-regulated devices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Enterprise, Ezra, Spectrum Solutions.
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