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MedTech News for Allumiqs, MangoRx, Ventris
Allumiqs and Prolytix’s Partnership; Setpoint Medical’s Neuroimmune Modulation Platform gets FDA Breakthrough Designation; MangoRx Launches ‘PRIME’ with FDA-approved TRT; SeaStar Medical Updates Quelimmune Commercial Launch; Ventris Medical Gains 510(k) for Amplify® Bone Graft Putty

MangoRx Officially Launches ‘PRIME’ by MangoRx, Powered by Kyzatrex®️ FDA Approved Oral Testosterone Replacement Therapy (TRT) Treatment On March 12, 2024, Mangoceuticals, Inc. unveiled a groundbreaking development eagerly awaited by many: the launch of 'PRIME' by MangoRx, Powered by Kyzatrex®️. This release mar...

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MedTech News for Philips, Boston Scientific, Varian
Philips Teamed with SyntheticMR; BioPhotas’s Celluma Light Therapy; Boston Scientific’s AGENTTM Drug-Coated Balloon; Varian’s TrueBeam and Edge Radiotherapy Systems; Carthera’s Brain-Blood Barrier Trial; Prototype Device Effectively Treated Multiorgan Failure

Philips Teamed with SyntheticMR to Deliver Breakthrough AI-based Quantitative Brain Imaging in MR to Advance Neurology Care For Patients On March 01, 2024, Philips in collaboration with SyntheticMR announced the launch of Smart Quant Neuro 3D, a significant advancement in objective decision support for diag...

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MedTech News for Dexcom, Philips, Toku, Carthera
Cerenovus Launched Next-Gen Stroke Revascularization Catheter; Dexcom Launched New ONE+ CGM System; Philips Received the US FDA Nod for Latest Intellivue Patient Monitor Software; Toku Obtained CE and UKCA Marks for AI Cardiovascular Risk Assessments; Genesis MedTech Completed Enrollment in TAVR Trial; Carthera’s Ultrasound Drug Delivery Trial

J&J’s Cerenovus Launched Next-Gen Stroke Revascularization Catheter On February 7, 2024, Johnson & Johnson MedTech’s Cerenovus announced the launch of its next-generation CereGlide 71 intermediate catheter with TruCourse indicated for the revascularization of patients suffering from acute ischemic stroke...

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MedTech News for Samsung, BIOCORP, CroiValve, FastWave Medical
Samsung Partnered with Lunit; Boston Scientific Launched VersaVue single-use Flexible Cystoscope; Element Science’s Patch-wearable Cardioverter Defibrillator; BIOCORP Received 510(k) FDA Clearance for SoloSmart; FDA IDE for CroiValve’s Tricuspid Heart Valve; FastWave Medical’s First-in-human Study of its IVL Tech

Samsung partnered with Lunit on AI for Enhanced Chest Screening On January 25, 2024, Samsung entered into a supply collaboration with Lunit, in order to employ its AI-powered technology for conducting chest screenings.  The agreement was signed by Boston Imaging, which serves as the U.S. hub for Samsung's d...

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MedTech News for AngioDynamics, Enhatch, AbSolutions
FDA Breakthrough Device Designation to Pi-Cardia’s ShortCut; AbSolutions Med’s REBUILD Bioabsorbable Abdominal Wall Closure Device; AngioDynamics Announces FDA 510(k) Clearance of Auryon XL Radial Access Catheter; Enhatch Announces FDA Clearance for a TKA Patient-Specific Instrumentation System

Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™ Pi-Cardia Ltd., a prominent player in advancing catheter-based leaflet modification solutions for heart valve treatment, revealed that its ShortCut™ device has attained Breakthrough Device Designation from the US Food and Drug Administration. S...

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MedTech News for Epredia, Olympus, Neuralace, Bloomlife
Epredia Announced the US Launch of SlideMate Laser; Olympus, Canon Medical Announced Partnership; FDA Cleared Painful Diabetic Neuropathy Neurostim Therapy from Neuralace; FDA Clearance to Bloomlife’s Bloomlife MFM-Pro; BrainsWay Initiated New Studies of Non-Invasive Neurostim; Gore Enrolled First Patients in Expandable Stent Graft Trial

Epredia Announced the US Launch of SlideMate™ Laser, Providing State-of-the-Art Precision Slide Printing for Pathology Laboratories On January 11, 2024, Epredia, a global leader in precision cancer diagnostics, announced that the company launched US sales of SlideMate™ Laser, the newest addition to the company’s...

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MedTech News for Savara, CRVx, Gore, Masimo
Savara Introduced aPAP ClearPathTM; RaySearch Released RayStation 2024A; FDA Approved Expanded Label for CVRx Neuromod Tech; FDA Clearance to Masimo’s Baby Monitoring System; Kansas City Proton Institute’s Advanced MEVION S250i Proton Therapy System; Gore’s Arise II Pivotal Study of the Gore® Ascending Stent Graft

Savara Introduced aPAP ClearPathTM to detect Autoimmune Pulmonary Alveolar Proteinosis  On December 21, 2023, Savara, a clinical stage biopharmaceutical company launched aPAP ClearPathTM, which is used by the physicians to obtain a conclusive diagnosis of Autoimmune Pulmonary Alveolar Proteinosis (aPAP), a ...

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MedTech News for Cardiovascular Systems, Koneksa, Medcura, Abbott, Enovis, Bausch + Lomb, AcuFocus
First Patient Enrolled in Kaizen Clinical Study in Japan; Koneksa’s At-Home Mobile Spirometry Clinical Trial; Medcura’s LifeGel™ Absorbable Surgical Hemostat; FDA Clearance to Abbott’s NAVITOR; Enovis’s DynaClip Delta™ and DynaClip Quattro™ bone staples; Bausch + Lomb Acquired AcuFocus

First Patient Enrolled in Kaizen Clinical Study in Japan  On January 11, 2023, Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional treatment systems for patients suffering from peripheral and coronary artery disease, announced the initiation of the...

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MedTech News for BioGX, Stryker, Boston Scientific, Agilent, DexCom
BioGX’s ‘pixl’ Portable qPCR Platform; Stryker’s Citrefix Suture Anchor System; Boston Scientific to Acquire Majority Stake of Acotec Scientific; FDA Approved the Dexcom G7 CGM System; Agilent’s NSCLC Liquid Biopsy Companion Diagnostic Test Approval; ClearPoint Neuro’s Prism™ Neuro Laser Therapy

BioGX Announced Ex-US Commercial Launch of ‘pixl™’ Portable qPCR Platform On December 8, 2022, BioGX, a global provider of easy molecular diagnostic solutions, announced the Ex-US commercial release of BioGX's portable pixl™ qPCR real-time PCR platform for use with BioGX CE-IVD approved assays.&nbs...

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