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 ...
THINK Surgical Receives FDA 510(k) Clearance for Use of LinkSymphoKnee (LSK) implants With TMINI Miniature Robotic System
THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug ...
MassDevice13h
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.
Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) Submission
PK Study Successfully Demonstrates that Fingerprint Sweat Provides Reliable Sample for Drug DetectionFDA 510(k) Clearance ...
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FDA Clears Spectral 4DCT for Precision in Radiation Oncology
The FDA-cleared Spectral CT 7500 RT, a detector-based computed tomography radiotherapy solution aimed to enhance radiation ...
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Zeta Surgical gains FDA 510(k) clearance for Navigation System
The US Food and Drug Administration (FDA) has granted special 510(k) clearance to the Zeta Surgical Navigation System, ...
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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 ...
Acuitive Technologies Receives FDA 510(k) Clearance for CITREPORE™, A New Synthetic Bioactive Bone Void Filler for Orthopedic Procedures
Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CITREPORE, a ...
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Philips receives FDA 510(k) clearance for Spectral CT 7500 RT
Royal Philips (PHG) announced a major advance in radiation oncology with 510(k) clearance from the US Food and Drug Administration for its new detector-based spectral computed tomography radiotherapy ...
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Sonoma Pharmaceuticals Receives New FDA 510(k) Clearance for Microcyn(R)-based Wound Care Hydrogel
"This new 510(k) clearance from the FDA demonstrates the superior safety and efficacy of Sonoma's wound care products," said Amy Trombly, CEO of Sonoma. "Our Microcyn technology-based hydrogel is ...
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Sonoma Pharma receives US FDA 510(k) clearance for Microcyn-based wound care hydrogel
Sonoma Pharma receives US FDA 510(k) clearance for Microcyn-based wound care hydrogel: Boulder, Colorado Wednesday, November 13, 2024, 16:00 Hrs [IST] Sonoma Pharmaceuticals, Inc.