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    Bioretec’s spine implant secures FDA breakthrough device status

    The US Food and Drug Administration (FDA) has awarded breakthrough device designation for Bioretec’s RemeOs Spinal Interbody Cage implant, marking a significant advancement in...

    SetPoint Medical wins FDA breakthrough nod for nerve stim tech for multiple sclerosis

    SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform.Valencia, California–based SetPoint designed its nerve modulation technology for...

    Pulse Biosciences secures FDA approval for CellFX nsPFA system

    US-based bioelectric medicine company Pulse Biosciences has received the US Food and Drug Administration (FDA) 510(k) approval for its CellFX nsPFA (nanosecond pulsed field...

    FDA panel gives go-ahead to Lumicell’s breast cancer detection tool

    A US Food and Drug Administration (FDA) panel has issued a positive recommendation for Lumicell’s surgical imaging tool for breast cancer detection. The FDA’s Medical...

    SurGenTec wins FDA nod for hydrophilic synthetic bone graft

    SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft.OsteoFlo HydroPutty follows the company’s OsteoFlo NanoPutty, which received...

    RDS granted CE mark for MultiSense remote monitoring wearable

    Stéphanie Hilbold, director of quality assurance and regulatory affairs at RDS, said: “Achieving this pivotal milestone is testament to the hard work of our...

    EDAP obtains FDA breakthrough status for endometriosis device

    EDAP TMS, a developer of invasive medical devices, has received the US Food and Drug Administration’s (FDA) breakthrough device designation for its Focal One...

    Axena secures new HCPCS code for Leva Pelvic Health System

    Axena Health has announced that its Leva Pelvic Health System received a new Healthcare Common Procedure Coding System (HCPCS) Level II code from the...

    FDA Clears AIOMEGA’s AIO Breathe, for Treatment of Obstructive Sleep Apnea

    AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and...

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