Cero Therapeutics receives FDA clearance of IND application for CER-1236
CERo Therapeutics (CERO) announces that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug ...
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Philips obtains FDA clearance for radiotherapy scanner combining 4D and spectral CT in one scan
Philips has secured an FDA clearance for what it describes as the world’s first imager to combine spectral CT with ...
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GEHC Stock Falls Despite FDA Clearance for SIGNA MAGNUS MRI System
GE HealthCare Technologies GEHC recently announced the receipt of FDA clearance for its SIGNA MAGNUS, a 3.0T high-performance ...
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FDA clears SonoMotion’s Stone Clear device to treat kidney stone fragments
The device uses external ultrasound pulses to facilitate the passage of residual fragments in a clinical setting.
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FDA clears outpatient cardiac telemetry for SmartCardia ECG patch
SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG ...
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GE HealthCare's Head-Only MRI System Gets FDA Clearance
(RTTNews) - GE HealthCare Technologies Inc. (GEHC) Wednesday said that it has received FDA 510(k) clearance for its innovative SIGNA MAGNUS 3.0T high-performance, head-only magnetic resonance imaging ...
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Philips wins FDA clearance for new detector-based radiotherapy system
Philips announced that the FDA granted 510(k) clearance for its new detector-based spectral computed tomography (CT) ...
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Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) Submission
FDA 510(k) Clearance Would Enable the Introduction of INBS’ Technology to the US in 2025 NEW YORK, Nov. 13, ...
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Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial
“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic ... STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance ...
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HuidaGene Therapeutics' IND application for HG202 for the treatment of nAMD cleared by FDA
FDA clearance of HG202 marks a significant milestone for CRISPR/Cas13 RNA-editing in clinical applications for nAMD. The ...
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Spectral 4DCT imaging receives FDA clearance
Designed specifically for use in radiation oncology, new Spectral CT 7500 RT enables personalized radiation therapy planning ...
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Frontier X Plus Revolutionizes Heart Monitoring with FDA Clearance
Fourth Frontier has achieved a crucial milestone with the FDA's clearance of the Frontier X Plus, a single-lead ECG monitor. Positioned to enhance heart health monitoring, this wearable device ...