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 ...
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 ...
TMCnet10h
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 ...
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 ...
FDA grants Sonoma 510(k) approval for Microdacyn Hydrogel
The FDA posted online 510(k) approval for Sonoma Pharmaceuticals (SNOA)’ Microdacyn Hydrogel, which is intended for use of acute and ...
Yahoo Finance7d
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 ...
manilatimes6d
Philips Spectral CT 7500 RT, world's first spectral 4DCT respiratory-gated imaging receives FDA 510(k) clearance
Designed specifically for use in radiation oncology, new Spectral CT 7500 RT enables personalized radiation therapy planning ...
Morningstar7d
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 ...
TMCnet7d
Momentis Surgical Receives FDA 510(k) Clearance for Second Generation Anovo® Robotic Platform, Introducing Haptic Feedback and Dual-Mode Articulation
Momentis Surgical Ltd., a leader in robotic-assisted surgical innovation, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its second-generation Anovo ® robotic ...