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Medical Devices

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Establishment Labs Gains FDA Approval for Motiva Implants; Surmodics Receives 510(k) Clearance for Pounce™ XL Thrombectomy System; Synergy Spine Solutions Completes Patient Enrollment in Synergy Disc® 2-Level IDE Clinical Trial; Medtronic Reports Strong Lesion Durability Data for PulseSelect™ Ablation System and Expands AiBLE™ Spine Surgery Ecosystem with Siemens Healthineers Partnership; Globus Medical Launches New Orthopedic Trauma Solutions

Establishment Labs Received U.S. FDA Approval for Motiva Implants On September 26, 2024, Establishment Labs Holdings Inc., a global medical technology company focused on enhancing women’s health and wellness, particularly in breast aesthetics and reconstruction, announced that it received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants in both primary and revision breast augmentation. “Today’s approval is transformative for breast aesthetics in the United States. This is a new era, in which women now have a choice of highly differentiated technology that is bac...

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Cordis FDA Approval for MYNX CONTROL VENOUS Vascular Closure Device; Forma Medical’s Optimal Plating System FDA Approval; Virpax’s Swine Model Pilot Study Positive Results; SetPoint Medical Positive Topline Results from Pioneering RESET-RA Study; Signature Orthopaedics Partnered with THINK Surgical; Nusano and PharmaLogic Formed Strategic Supply Agreement

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Artivion and Endospan Agreement; Masimo and Cleveland Clinic Collaboration; Academic Medical Center’s Sedation-Free TNE With the EvoEndo Endoscopy System; IceCure’s Next-Gen XSenseTM Cryoablation System FDA Approval; KORU Medical Systems’ Clearance for FreedomEdge® Infusion System; Reflow Medical’s First Patient in Coronary Sirolimus-Eluting Retrievable Scaffold System

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Alcon’s 510(k) Clearance From the FDA; Globus Medical Received FDA Clearance; UK Pioneers First Skull-Mounted Epilepsy Device for Child; The Initiation of a Significant Clinical Trial of 3d Printed Models; Esaote Unveiled the Cutting-Edge Mylab™E80 @Sirm Ultrasound Device For 2024; Medasense Unveiled a Transformative Partnership With Nihon Kohden Corporation

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Understanding Asthma Diagnostic Devices: Enhancing Management and Care

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Boston Scientific Corporation Agreement to Acquire Silk Road Medical; Philips Introduced Duo Venous Stent System; Akili’s EndeavorOTC Received FDA Clearance; Roche Achieved FDA Clearance; atHeart Medical Reported Long and Short-term Clinical Data; Bioretec Announced Successful Clinical Outcomes

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Asensus Surgical Acquired by Karl Storz; Allosource® Launched Aceconnex®; Siemens Healthineers FDA Clearance for Chiller-Free Biograph Trinion PET/CT; Abbott Received FDA Clearance; Foldax® Reported Positive Clinical Results; Amber Implants Completed Enrolment of First-In-Human Clinical Trial

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Infusion Therapy Devices: Revolutionizing Healthcare Delivery

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Stryker’s LIFEPAK 35 Monitor/Defibrillator; Qiagen’s QIAstat-Dx Respiratory Panel; Evolution Optiks’s 510(k) Clearance; Microbot Medical Endovascular Surgical Robot Trial; Nexalin’s Insomnia and Anxiety Therapy Headset Clinical Trial; KORU Medical Systems’ Study With Commercialized Oncology Biologics

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Wireless Brain Sensors: Revolutionizing Neuroscience and Healthcare

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Solis Mammography’s Acquisition of MUSIC Imaging Center; Nikon’s SI-PH Phase Condenser Accessory Option; Teijin Launch Surgical Patch; Terumo Cardiovascular’s FDA 510(K) Clearance; Spineart’s 510(k) Clearance; Ceretrieve’s Success in FIH Ischemic Stroke Cases

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From Lab to Lifesaver: Advancing Artificial Blood Vessels for Healthier Tomorrows

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Laborie’s Enhanced Gastrointestinal Diagnostics; Carestream’s Image Suite MR 10 Software Launch; Implicity’s Heart Failure Algorithm FDA 510(k) Approval; AngioDynamics’ AlphaVac F1885 System CE Mark Approval; HeartBeam’s Artificial Intelligence Algorithm for Arrhythmias; Onward ARC-EX Nerve Stim Hit Pivotal Trial

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The Evolution and Impact of Surgical Cameras in Modern Medicine

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Siemens Healthineers USD 314 Million Investment; Samsung Medison’s Sonio Acquisition; Leo Cancer Care’s Upright Technology Clearance; OrthoXel’s Vertex Hip Fracture Nail FDA 510 (k) Clearance; SPR Therapeutics’ PNS Pain Relief Device Positive Data; Valneva’s Chikungunya Vaccine Positive Pivotal Phase III Data

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The Rise of Sleep Tech Devices: Unlocking Better Sleep

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Monteris Smallest Brain Laser Probe Launch; Vesica Health’s AssureMDx Test Launch; Anaut’s Eureka α Japanese Regulatory Approval; Geneoscopy’s Labcorp-Partnered Colon Cancer Test FDA Approval; Novel Omeza® OCM™ Diabetic Foot Ulcers Results; LEO Pharma Phase III Plaque Psoriasis Trial Results

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