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Tempus Receives U.S. FDA Approval for xT CDx, a NGS-Based In Vitro Diagnostic Device

Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first Premarket Approval (PMA) application for its…

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

 BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of…

stethoscope

Terumo Blood and Cell Technologies’ IMUGARD Platelet Pooling Set Cleared by FDA

RefleXion Medical, a therapeutic oncology company, today announced the U.S. Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX™ biology-guided radiotherapy, a cutting-edge treatment applicable…

RefleXion Receives FDA Clearance for SCINTIX Biology-Guided Radiotherapy

RefleXion Medical, a therapeutic oncology company, today announced the U.S. Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX™ biology-guided radiotherapy, a cutting-edge treatment applicable…

UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence

UroMems announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI.

Workforce Advancement

TEAMFund Releases 4th Annual Impact Report, Announces Raise of $150M Fund, and Grants 5th Annual Global Health Innovation Award for Female-Founded Medtech Companies

TEAMFund, a 501(c)(3) Public Charity and a For-Profit Impact Fund whose mission is to enhance patient access to medical technology in low resource settings, announced at The AdvaMed® The MedTech…

Regulatory Affairs

Renovia Receives FDA Clearance for leva® Pelvic Health System as First-line Treatment for Chronic Fecal Incontinence

Renovia Inc., an AdvaMed® member and developer of non-surgical, treatments for female pelvic floor disorders, announced the U.S. Food and Drug Administration (FDA) has cleared its leva® Pelvic Health System…

BlueWind Medical Raises $64 Million to Fund Innovative Technology for Overactive Bladder Treatment

BlueWind Medical, Ltd., AdvaMed® member and developer of the innovative RENOVA iStim™ implantable tibial neuromodulation (iTNM) device for treatment of Overactive Bladder, today announced the addition of Charles F. (“Chuck”)…

BlueWind Medical Ltd. Appoints Charles F. Cargile as Chief Financial Officer

BlueWind Medical, Ltd., AdvaMed® member and developer of the innovative RENOVA iStim™ implantable tibial neuromodulation (iTNM) device for treatment of Overactive Bladder, today announced the addition of Charles F. (“Chuck”)…

Regulatory Affairs

Cook Medical receives FDA Breakthrough Device Designation for Zenith® Thoraco+ Endovascular System

AdvaMed® member Cook Medical’s Zenith® Thoraco+ Endovascular System (Thoraco+) has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).

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