Medical Devices Market
Sep 12, 2024
SpectraWAVE raised $50M; Rockwell Medical signed dialysis deal; Modular Medical got FDA nod for Modd1 pump; iRhythm’s Zio approved in Japan; Autonomix trial showed 83% pain reduction; Insulin Efsitora Alfa improved A1C.
Modular Medical Announced the FDA Clearance for the Modd1 Insulin Pump On September 5, 2024, Modular Medical, Inc., an insulin delivery system technology company, announced that it received the U.S. Food and Drug Administration (FDA) clearance to market and sell its MODD1 pump in the United States. With it...
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Sep 05, 2024
Pensar Medical’s Partnership with Centurion Therapeutics; BD’ Acquisition of Critical Care; Haleon’s Launch of Eroxon; embecta Receives FDA Clearance; INFINITY-SWEDEHEART Trial of Elixir Medical’s DynamX Bioadaptor; Median Technologies’ Pivotal REALITY Study
Pensar Medical Entered Into a Partnership with Centurion Therapeutics for Innovative Negative Pressure Wound Therapy System On Aug 29, 2024, Pensar Medical, a pioneer in negative pressure wound therapy (NPWT), announced a strategic partnership with Centurion Therapeutics to distribute the Microdoc® sNPWT (...
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Aug 29, 2024
Insulet Corporation’s Omnipod® 5 Automated Insulin Delivery System Receives FDA Approval; FDA Gives Green Light to Expand Vericel’s MACI Arthro Label; SkinCure Oncology Announces New Study of Non-melanoma Skin Cancer Through Image-guided Superficial Radiation Therapy; SDC’s BYOD ePRO Solution Clinical Trial; PaceMate® Acquires Paceart Optima™ System; KARL STORZ Acquires a US-headquartered Company
FDA Cleared the Omnipod® 5 Automated Insulin Delivery System for Use in People with Type 2 Diabetes On August 26, 2024, Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod® brand of products, announced that its groundbreaking Omnipod 5 Automated Insulin Delivery Syst...
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Aug 22, 2024
Guard Medical Announced FDA 510(k) Clearance; PROCEPT BioRobotics Announced FDA Clearance; GE HealthCare Announced MASTER Trial Results; CollPlant and Stratasys Announced Pre-clinical Study; GE HealthCare Announced Collaboration to Investigate MRI Techniques; NOWDiagnostics’ Syphilis Test Received De Novo Marketing Authorization
Guard Medical Announced FDA 510(k) Clearance for Additional Large Sizes of its NPseal ® Surgical Dressing, Marking Product's Entry into the Orthopedic Market On August 19, 2024, Guard Medical, Inc., a medical technology company, announced FDA 510(k) clearance for expanded large sizes (up to 25cm) of its advanced...
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Aug 15, 2024
Masimo W1® Medical Watch Secured FDA 510(K) Clearance; Stereotaxis Received the CE Mark in Europe and Submitted a 510(K) Application in the US; Replimune Dosed First Patient in the IGNYTE-3 Clinical Trial; Daré Bioscience Announced the Publication of Positive Findings From the Phase IIb RESPOND Clinical Study; Baxter’s Definitive Agreement to Carlyle For USD 3.8 Billion; Moximed Successfully Closed a USD 91 Million Series D Financing Round
The Masimo W1® Medical Watch Secured FDA 510(K) Clearance for its Connectivity with the Masimo Safetynet® Telemonitoring System On August 12, 2024, Masimo announced that its Masimo W1® medical watch received FDA 510(k) clearance for connectivity. This approval enabled the watch to integrate with the Masimo...
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Aug 08, 2024
MIMEDX Launches HELIOGENTM Fibrillar Collagen Matrix; DocGo Launches Mobile X-ray Program; Labcrop’s FDA De Novo Marketing Authorization; Inspire Medical Systems Receives FDA Approval; Alcyone Therapeutics Announces Continued Enrollment Approval from the FDA; Lunit’s AI for Tuberculosis Detection
MIMEDX Announced the Launch of HELIOGENTM Fibrillar Collagen Matrix On July 31, 2024, MiMedx Group, Inc. launched HELIOGEN™ Fibrillar Collagen Matrix, a particulate xenograft product designed to treat complex wounds, especially in surgical environments. HELIOGEN is a shelf-stable product that contains Type...
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Aug 01, 2024
Stryker’s Spine Guidance 5 Software FDA Approval; VIALASE Received CE Mark; The Texas Heart Institute Implanted the BiVACOR® Total Artificial Heart; Diamyd Medical’s Phase 3 Trial Positive Results; Cardio Diagnostics Holdings Inc.’s CDIO.AI; GE Healthcare and AWS Strategic Collaboration
FDA Approved Stryker’s Spine Guidance 5 Software Featuring Copilot On July 30, 2024, Stryker, a global leader in medical technologies, announced that its Q Guidance System with Spine Guidance 5 Software featuring Copilot received 510(k) clearance from the U.S. Food and Drug Administration. This first-to-market t...
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Jul 25, 2024
STRATA Skin Sciences’ XTRAC Momentum™ 1.0 Device Approved in Japan; eCential Robotics Received FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device; MicroVention Announced the Results of the Clinical Evaluation of WEB™ 17 Device; Neuspera Medical, Inc.’s SANS-UUI Pivotal Clinical Trial; GE HealthCare Announced an Agreement to Acquire the Clinical Artificial Intelligence Business; Sutter Health Implemented World’s First Wearable Doppler Ultrasound Patch
STRATA Skin Sciences Announced That the Ministry of Health, Labor and Welfare Approved the XTRAC Momentum™ 1.0 Device in Japan, Specifically Designed to Treat Inflammatory Skin Conditions On July 22, 2024, STRATA Skin Sciences, Inc., a medical technology company specializing in developing, commercializing, and m...
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Jul 18, 2024
Inspira™ Approval of INSPIRA™ ART100 System; Oticon Medical’s Sentio™ System Received Regulatory Clearance; SpineGuard Filed its “510K” Dossier in the US; Vectorious Medical Technologies’ V-LAP Left Atrial Pressure Sensor Successful Implantation; Bedal International Raised $11 Million; Mytonomy Inc. Agreement With Vizient, Inc.
Inspira™ Secured Approval From Israeli Authorities for its INSPIRA™ ART100 System On July 11, 2024, Inspira™ Technologies OXY B.H.N. Ltd., a pioneering medical technology company, secured a pivotal milestone with the receipt of the Israeli Ministry of Health's medical devices and accessories ("AMAR") approval fo...
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Jul 11, 2024
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
Cordis Secured FDA Approval for MYNX CONTROL VENOUS Vascular Closure Device, Expanding Proven MYNX Technology to Mid-Bore Venous Puncture Sites On July 9, 2024, Cordis, a leading company in cardiovascular and endovascular technology, received FDA approval for its MYNX CONTROL™ VENOUS Vascular Closure Device. Thi...
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