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Axial3D Receives FDA Clearance for Axial3D INSIGHT™ Medical Image Segmentation Platform

Legacy MEDSearch

Axial3D, a leader in medical segmentation and 3D solutions, today announced that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications.

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NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64

Legacy MEDSearch

BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. the healthcare subsidiary of Samsung Electronics Co., the healthcare subsidiary of Samsung Electronics Co., About NeuroLogica.

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AccurKardia’s AccurECG™ Analysis System Receives FDA 510(k) Clearance

Legacy MEDSearch

AccurKardia , a medical technology company delivering clinical-grade ECG interpretation software, announced today that its flagship product, the AccurECG Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance. It is indicated for adults aged 22 and older.

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Ceribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityPro™ Software with Electrographic Status Epilepticus Diagnostic Indication

Legacy MEDSearch

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. per eligible Medicare patient case.

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Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

Legacy MEDSearch

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

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Hemosonics Awared FDA 510(k) Clearance for Quantra® Hemostasis System with QSTAT® Cartridge

Legacy MEDSearch

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. The FDA clearance of the QStat Cartridge expands the Quantra System’s indications for use to include trauma, and liver transplantation procedures. HemoSonics’ manufacturing, R&D, and Headquarters are based out of Durham, NC.

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Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

Legacy MEDSearch

Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Innovation in the baby care space matters because some of the largest issues facing caregivers and healthcare providers have yet to be solved. BabySat will be available in the U.S.