receive fda clearance
Subtle Medical Receives FDA 510(K) Clearance for AI-Powered SubtleMR
"One of the most exciting things about deep learning reconstruction is how it redefines the usual negotiation between exam time and image quality. This could lead to significant downstream value for imaging operations and for patient experience," said Christopher Hess, MD, Chair of the Department of Radiology and Biomedical Imaging at UCSF. SubtleMR delivers a significant improvement in the quality of noisy images, which is particularly beneficial for patients who have difficulty holding still for long periods of time. Artifact-ridden images and the need for re-scans are a challenge for both patients and physicians. SubtleMR integrates seamlessly into the radiology workflow, and it is compatible with any brand of MRI scanner and PACS.
- Health & Medicine > Diagnostic Medicine > Imaging (1.00)
- Government > Regional Government > North America Government > United States Government > FDA (0.92)
Subtle Medical Receives FDA 510(k) Clearance for AI-Powered SubtleMR
"One of the most exciting things about deep learning reconstruction is how it redefines the usual negotiation between exam time and image quality. This could lead to significant downstream value for imaging operations and for patient experience," said Christopher Hess, MD, Chair of the Department of Radiology and Biomedical Imaging at UCSF. SubtleMR delivers a significant improvement in the quality of noisy images, which is particularly beneficial for patients who have difficulty holding still for long periods of time. Artifact-ridden images and the need for re-scans are a challenge for both patients and physicians. SubtleMR integrates seamlessly into the radiology workflow, and it is compatible with any brand of MRI scanner and PACS.
- Health & Medicine > Diagnostic Medicine > Imaging (1.00)
- Government > Regional Government > North America Government > United States Government > FDA (0.85)
Omega Medical Imaging First in the World to Receive FDA Clearance on Artificial Intelligence Imaging System that Reduces Dose - Omega Medical Imaging
Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, just announced the Food and Drug Administration 510 (k) clearance of FluoroShield with their 2020 Cardiac Flat Panel Detector. The unique FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a perspective of surrounding anatomy. The blended image incorporates a lower frequency refresh of the peripheral image area. This combined image (live fluoroscopy or cine of ROI background refreshed at a rate of once or twice per second) increases the quality of information presented during interventional procedures. Brian Fleming, President of Omega Medical Imaging states, "Until now products on the market have only been able to manage radiation to patients and staff. FluoroShield is the only system in the world that provides an actual reduction in dose. The impact of this groundbreaking solution for patients and healthcare providers is substantial. I am very grateful to be a part of a team that pushes the envelope in the development of safer healthcare solutions."
PhysIQ Inc. Receives FDA Clearance of Continuous Ambulatory Respiration Rate Algorithm Enabling Artificial Intelligence-based Analytics for Biopharma Companies and Payers
CHICAGO – PhysIQ, a leader in applying artificial intelligence to wearable sensor data, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their algorithm to continuously determine respiration rate in ambulatory patients. This clearance adds to their expanding portfolio of FDA-cleared cloud-based analytics, which also include QRS detection, heart rate, heart rate variability, atrial fibrillation detection, and their personalized physiology change detection analytic. The latest clearance advances physIQ's strategy to offer a deep portfolio of FDA-cleared analytics that can be applied to wearable sensor data. To enable this, physIQ's platform collects raw telemetry from the device and uploads it to the cloud where FDA-cleared analytics use the raw biosignals to produce vital signs. With this approach physIQ is able to provide vital sign analytics that benefit from the superior computing power of the cloud and fuel the higher-level analytics that further characterize dimensions of human physiology.