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FDA grants 510(k) clearance to Philips ROCC capabilities
A pilot study conducted at Imperial College Healthcare NHS Trust in London reported a 9% increase in scanning throughput.
Orthopedics This Week2d
FDA Clears Dr. Betz’s Vertebral Body Replacement Device
The U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance to a novel spinal vertebral body replacement device ...
BrightHeart receives 510(k) clearance from FDA for prenatal ultrasound software
The software is designed to improve the accuracy of detecting morphological abnormalities during foetal heart ultrasound ...
Imidex to Sell Company at RSNA in Chicago, Featuring Leading FDA 510(k) Cleared AI Technology for Lung Nodule and Mass Detection
Imidex, a leader in developing artificial intelligence solutions for medical imaging, today announced plans to sell the company at the Radiological Society of North America (RSNA) 2024 Annual Meeting ...
Medical Design and Outsourcing4d
FDA warns of device shortage after Class I recall for silicone debris injuries
The FDA is warning about a shortage of endoscopic vessel harvesting devices following the Getinge/Maquet VasoView HemoPro ...
eWeek7d
FDA Clears BrightHeart’s AI Ultrasound Software for Fetal Heart Monitoring — What This Means for Expecting Parents
BrightHeart's revolutionary AI ultrasound software has received FDA clearance, transforming fetal heart monitoring for ...
Asia One6d
Neurophet Secures FDA 510(k) Clearance for Multiple Sclerosis Analysis with 'Neurophet AQUA'
New features include advanced analysis of multiple sclerosis (MS) and white matter hyperintensities alongside brain atrophy ...
Pharmabiz4d
Philips advances remote imaging leadership with US FDA 510(k) clearance for innovative remote scanning and protocol management capabilities
Philips advances remote imaging leadership with US FDA 510(k) clearance for innovative remote scanning and protocol management capabilities: Amsterdam, the Netherlands Wednesday, ...
GlobalData on MSN6d
LifeSignals gains FDA approval for wearable biosensor
The UbiqVue 2A multi-parameter system biosensor is worn on the chest and collects biodata across 13 monitored parameters.
MassDevice13d
BrightHeart earns FDA clearance for AI-powered prenatal heart ultrasound tech
BrightHeart announced that it received FDA 510(k) clearance for its first AI software for prenatal ultrasound evaluations of ...
MassDevice13d
Think Surgical wins another FDA clearance for its surgical robot
Think Surgical announced today that it received FDA 510(k) clearance to use its TMINI surgical robot with the LinkSymphoKnee.
Yahoo Finance6d
FDA grants 510(k) clearance to Philips ROCC capabilities
Philips has received the US Food and Drug Administration (FDA) 510(k) clearance of remote scanning and protocol management capabilities on Radiology Operations Command Center (ROCC). This approval ...