FDA Clears XACT Robotics Technology
XACT Robotics announces U.S. FDA clearance for a modification to its cleared XACT ACE Robotic System designed to support robotic insertion and steering of ablation probes during ablation clinical procedures.
Category: Clearances
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FDA Clears Masimo Pediatric Brain Function Monitoring and EEG Sensor
The FDA has cleared Masimo SedLine brain function monitoring for pediatric patients under the age of 18 and its SedLine Pediatric EEG Sensor.
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FDA OKs Siemens Healthineers CT Scanner
Malvern, Pa.-based Siemens Healthineers announces that the U.S. FDA has cleared SOMATOM X.ceed, a single-source CT scanner that combines high-speed scanning capabilities with a new hardware/software combination to streamline CT-guided interventions.
Clearances
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FDA Clears XACT Robotics Technology
XACT Robotics announces U.S. FDA clearance for a modification to its cleared XACT ACE Robotic System designed to support robotic insertion and steering of ablation probes during ablation clinical procedures.
Why Courts Should Bring Back Evidence of FDA Clearance in Medical Device Trials
Not allowing medical device companies to present information about the FDA’s analysis of their products in product liability cases against them results in unfair court trials, posits an article by Reuters.
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FDA Clears EndoFresh Disposable Digestive Endoscopy System
The EndoFresh Disposable Digestive Endoscopy System features a camera system with an all-in-one design, disposable upper GI endoscope, and disposable colonoscope.
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FDA Clears GE Healthcare AI MRI Technology
Waukesha, Wis.-based GE Healthcare announces that AIR Recon DL, a deep-learning image reconstruction technology that works across all anatomies, is now U.S. FDA 510(k) cleared on Signa 7.0T MRI scanners.
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FDA Clears Masimo’s Radius PCG for the Root Patient Monitoring and Connectivity Platform
Irvine, Calif.-based Masimo announces that Radius PCG, a portable real-time capnograph with wireless Bluetooth connectivity, has received U.S. FDA 510(k) clearance.
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FDA OKs Single-Source Nanox.ARC Digital X-Ray
Israel-based medical imaging technology company Nanox announces that it has been granted 510(k) clearance from the U.S. FDA for its single-source Nanox.ARC digital x-ray technology.
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FDA Clears Baxter AK 98 Dialysis Machine
AK 98 offers encrypted, two-way connectivity, which enables the system to pull prescriptions directly from the EMR for simplified workflow and data handling.
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FDA Clears Next-Gen NeuroCap EEG Headset
NeuroCap is a disposable pre-gelled EEG headset with 22 electrodes and 19 active EEG channels located in accordance with the 10-20 system.
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