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    Alimetry gets FDA clearance for wearable gut disorder test

    The company has also launched a distribution unit in the United States. Auckland-based health technology startup Alimetry has received clearance from the US Food and...

    Senseonics wins CE mark approval for 180-day Eversense E3 CGM

    Senseonics announced that it received CE mark for the next-generation Eversense E3 CGM system. Germantown, Maryland-based Senseonics offered a previous-generation continuous glucose monitor (CGM) with a...

    FDA clears Ekso Bionics’ robotic exoskeleton for use with MS patients

    Ekso Bionics (Nasdaq:EKSO) announced that it received FDA 510(k) clearance for its EksoNR robotic exoskeleton. Richmond, California–based Ekso Bionics designed the EksoNR technology for use with...

    Rune Labs scores FDA 510(k) to monitor Parkinson’s symptoms

    The StrivePD app uses Apple's Movement Disorder API to track tremors and uncontrolled body movement. Brain data startup Rune Labs announced Tuesday it received FDA 510(k) clearance to use...

    EarliTec Diagnostics Receives FDA 510(k) Clearance for the EarliPoint Evaluation for Autism Spectrum Disorder

    EarliTec Diagnostics, Inc. (“EarliTec”), a digital health company developing novel diagnostic and therapeutic products for children with autism spectrum disorder (ASD) and early childhood...

    FDA clears lumbar interbody fusion device from Zavation Medical

    Zavation Medical announced that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion device. Flowood, Mississippi-based Zavation designed the eZspand lateral, part...

    US FDA approves Medicalgorithmics’ Qpatch ECG monitoring device

    The device includes an eInk screen that allows physicians and patients to interact with the wearable. The US Food and Drug Administration (FDA) has approved Medicalgorithmics’ ECG...

    Okami Medical secures FDA 510k clearance for vascular occluders

    LOBO-7 and LOBO-9 are intended for use in 5mm to 7mm and 7mm to 9mm diameter vessels, respectively. Okami Medical has received 510k clearance from the US...

    Aurora Spine Corporation Receives FDA 510(k) Clearance for DEXA SOLO-LTM Anterior Lumbar Interbody Fusion Device as part of its DEXA Technology Platform

    Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes,...

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