Neuromodulation Devices
Aug 14, 2025
Nyxoah Secures FDA Nod for Genio® System in OSA Treatment; FDA Grants First 510(k) Clearance to DeepSight™-Powered NeedleVue™ LC1 Ultrasound System; TITAN CSR® Retractor Tops U.S. Military List for Trauma Care in Deployed Settings; FDA Clears Myra Vision to Begin US IDE Study for Glaucoma; HistoIndex Advances Fibrosis Assessment with AI-Powered FibroSIGHT™ Plus; Gentuity Partners with GE HealthCare to Broaden Access to Cutting-Edge Intravascular Imaging
FDA Approves Nyxoah’s Genio® System for Treating Obstructive Sleep Apnea On August 08, 2025, Nyxoah SA, a medical technology company that developed breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, announced that the U.S. Food and Drug Administration (FDA) had a...
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Aug 07, 2025
SetPoint Medical Earns FDA Nod for First-of-Its-Kind Neuroimmune Modulation Therapy in RA; Body Vision Medical Secures Singapore Pre‑Market Approval for LungVision; BioLab Holdings Initiates Landmark Clinical Trial for Placental Membrane Therapies; Concept Medical Launches MAGICAL-SV IDE Trial; Frenova Enters Strategic Partnership to Push Boundaries in Kidney Precision Medicine; Demetra Acquires OrthoFundamentals and Establishes Global Spine Division
SetPoint Medical Received FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis On July 31, 2025, SetPoint Medical, a company focused on developing therapies for individuals with chronic autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) approved its Se...
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Jun 19, 2025
Presidio Medical™ Gains IDE Nod for ULF™ Study, Names Dimas Jiménez CFO; Creo Medical Gains FDA Nod for SpydrBlade™ Flex, Paving Way for U.S. Launch; Penumbra Completes Patient Enrollment in Pivotal STORM-PE RCT; Adona Medical Completes Enrollment in First-in-Human Trial of Novel Interatrial Shunt for Heart Failure; Johnson & Johnson Launches TECNIS Odyssey Intraocular Lens in Europe, Middle East, and Canada for Enhanced Cataract Care; Philips Sets New Benchmark in POCUS Technology with Flash 5100 Launch
Presidio Medical™ Received IDE Approval for Ultra Low Frequency (ULF™) Neuromodulation Clinical Study and Appoints Dimas Jiménez as Chief Financial Officer On June 12, 2025, San Mateo, California–Presidio Medical, Inc., a global clinical-stage medical device company, received Investigational New Drug (IDE)...
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Feb 13, 2025
Agiliti Launches Essentia; KUBTEC Introduces PICASSO Plus; FDA Clears Neuvotion’s NeuStim™ for Non-Invasive Hand Stimulation in Stroke & SCI Patients; Ibex Medical Analytics Achieves Milestone with FDA 510(k) Clearance; BlueWind Medical Reports Strong Two-Year Outcomes for Revi® System in Peer-Reviewed Study; Reprieve Cardiovascular’s FASTR Pilot Trial Shows Positive Outcomes, FDA Approves IDE for Next Phase
Agiliti Launched Essentia, an Innovative Multi-Acuity Hospital Bed that Helps Lower Patient Risk and Accelerate Mobility On February 11, 2025, Agiliti, a prominent manufacturer and provider of medical device solutions for the U.S. healthcare industry, introduced Essentia™, a versatile multi-acuity bed fram...
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Feb 06, 2025
Bioretec Ltd. Gains CE Mark for RemeOs™ Trauma Screw; HoneyNaps’ AI Sleep Diagnostic Software Achieves Recognition as the 73rd and 74th Innovative Medical Devices by South Korea’s MFDS; Movano Health Advances Clinical Trials for Innovative Non-Cuff Blood Pressure Monitor; IRB Approves PathMaker Neurosystems’ MyoRegulator® ALS Study; Aspen Medical Products Closes Deal to Acquire Advanced Orthopaedics; Surmodics Achieves Early Clinical Success with Pounce™ XL Thrombectomy System
Bioretec Ltd. Secured CE Mark Approval for RemeOs™ Trauma Screw, Enabling European Market Launch On January 31, 2025, Bioretec Ltd., a leader in absorbable orthopedic implants, successfully completed the CE mark approval process and began the commercialization of its RemeOs™ Trauma Screw product portfolio ...
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May 09, 2024
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
Monteris Launched Smallest Brain Laser Probe on the Market On May 01, 2024, Monteris Medical launched the NeuroBlate® NB3™ FullFire® 1.6mm laser probe, the company’s latest product line innovation for use with their market-leading NeuroBlate System. The NB3 laser probe, which integrates Monteris' patented coo...
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Apr 25, 2024
iVEAcare’s $27.5 Million Series A Funding; AI Medical Service Joint Research Agreement with Mahidol University; CERENOVUS Launched Catheter; Cochlear FDA Clearance for The Osia System; Immunovia Announced Positive Results From The Model-Development Study; Hyalex Orthopaedics First Patients Treatment
iVEAcare Launched $27.5 Million Series A Funding from Leading Medtech Investors On April 24, 2024, iVEAcare, announced the closure of a $27.5 million Series A financing. The financing was led by Vensana Capital, which was joined by Treo Ventures, Hatteras Venture Partners, and an undisclosed strategic partner. i...
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Dec 28, 2023
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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Dec 21, 2023
Integra to Buy J&J’s Acclarent; B. Braun Launches the CARESITE Micro Luer Access Devic; FDA Approves Medtronic’s Novel PulseSelect Pulsed Field Ablation System; FDA Clearances to Perfuze’s Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment; ShiraTronics Successfully Implants First Migraine System; Sight Sciences Announced the Six-Month Results For Heat Therapy Device
Integra LifeSciences to Buy Johnson & Johnson’s Acclarent and its ENT Tech On December 13, 2023, Integra LifeSciences entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech. Acclarent strengthens Integra's position in the ENT treatment market. Acclarent is a component of ...
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Oct 19, 2023
Mindray Collaborated with Edwards Lifesciences; DuPont’s Low-Cyclics Silicone Soft Skin Adhesive; GE HealthCare’s Allia IGS Pulse; Praxis Medical’s EndoCore EBUS-TBNA Biopsy Device; Visioneering’s PROTECT Clinical Trial; SynerFuse’s e-TLIF procedure
DuPont Launched Higher-Adhesion and Low-Cyclics Silicone Soft Skin Adhesive On October 17, 2023, DuPont, a globally recognized leader in technology for a broad range of innovations in medical devices, biopharmaceutical processing, and pharmaceutical solutions launched Liveo™ MG 7-9960 Soft Skin Adhesive. ...
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