Spinal Cord Stimulators
Jul 16, 2026
POLYTECH Announced Regulatory Clearance for Improvements to the Microthane Process; ElectroWire Medical Earns 510(k) Clearance for LightningWire™ System; NeuroLexIQ Partners with Canary Speech to Introduce AI-Driven Voice Analysis for Injury Intake; BIOTRONIK Neuro Acquires Spinal Cord Stimulation Technology from Soin Neuroscience; Lakewood-Amedex Biotherapeutics Highlights Preclinical Safety Evidence Ahead of Nu-3 Gel Phase 2a Study; Cumulus Neuroscience Presents Evidence That Two-Minute Digital Test Enhances Alzheimer’s Trial Pre-enrichment
POLYTECH Announced the Approval of an Updated Process for Microthane® On 16 July 2026, POLYTECH Health & Aesthetics announced the approval of its updated proprietary manufacturing process for Microthane®, its polyurethane-coated breast implant technology. The company stated that the revised process was...
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Feb 11, 2026
The Future of Pain Management Devices: AI and Digital Integration
The convergence of artificial intelligence and connected health technologies is fundamentally transforming chronic pain management, shifting from reactive treatment protocols to proactive, personalized care systems. This integration represents not merely an incremental improvement but a paradigm shift in how patien...
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Sep 11, 2025
ONWARD Medical’s ARC-EX System Gains CE Mark; Microbot Medical Secures FDA 510(k) Clearance for LIBERTY® Endovascular Robotic System; Fraiya Launches Major NHS Clinical Trial Using AI for Pregnancy Ultrasounds; Medtronic Hugo™ Robotic-assisted Surgery System in Hernia Repair Met Safety and Effectiveness Endpoints; Willow Launches Willow Wave, Pioneering a New Standard in Breastfeeding; Vivalink Launches New Adhesive to Improve Wearable ECG Performance
ONWARD Medical Received CE Mark for ARC-EX, Enabling Commercial Launch of Breakthrough Spinal Cord Stimulation System in Europe On September 8, 2025, ONWARD Medical N.V., a leading neurotechnology company developing therapies to restore movement, function, and independence for individuals with spinal cord ...
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Aug 21, 2025
FDA Grants 510(k) Clearance to Nerveblox AI; Labcorp Introduces the First FDA-Cleared Alzheimer’s Blood Test; Calidar Introduces First-of-its-Kind 4D Mammography System; ONWARD Medical to Initiate Empower BP Pivotal Study Following FDA IDE Approval; Tenon® Medical Launches Catamaran® SE SI Joint Fusion System Nationwide; Rivanna Secures $800,000 Virginia Catalyst Grant Plus Matching Funds to Advance AI-Driven Ultrasound Innovation
Nerveblox, the Ultrasound AI for Regional Anesthesia Received FDA Clearance On August 18, 2025, Nerveblox, an AI-powered software developed by SmartAlpha to assist physicians in performing ultrasound-guided regional anesthesia, received U.S. Food and Drug Administration (FDA) 510(k) clearance. This milesto...
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Jan 16, 2025
Johnson & Johnson MedTech Secures CE Mark for Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter; Medtronic Secures CE Mark for BrainSense™ Adaptive Deep Brain Stimulation; Inquis Medical Finalizes Enrollment for U.S. Pivotal Study on Aventus Thrombectomy System for Pulmonary Embolism; First Patient Enrolled in Argon Medical’s CLEAN-PE Study for Novel Pulmonary Embolism Therapy; Sutter Health and GE HealthCare Partner to Revolutionize Patient Care with AI-Driven Imaging Solution; Saluda Medical Closes $100M Financing to Expand Neuromodulation Portfolio
Johnson & Johnson MedTech Announced CE Mark Approval for Dual Energy THERMOCOOL SMARTTOUCHTM SF Catheter, Bolstering Capabilities in Cardiac Arrhythmias Treatment On January 10, 2025, Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the receipt of European CE ma...
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Jan 09, 2025
Roche Secures FDA Clearance for High-Volume Slide Scanner; Pacira Gets 510(k) Approval for Iovera° SmartTip for Chronic Back Pain; ClearCut Presents Clearcoast™ Study Results at San Antonio Breast Cancer Symposium; NanoVibronix Completes UroShield® Pilot Study at University of Michigan; Hologic Finalizes Acquisition of Gynesonics; Movano Health Launches EvieAI Virtual Wellness Assistant.
Roche's Momentum in Digital Pathology Continued With FDA Clearance on its High-Volume Slide Scanner On January 09, 2025, Roche announced that its whole slide imaging system, Roche Digital Pathology Dx, received an additional 510(k) clearance from the United States Food and Drug Administration (FDA). This c...
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Nov 14, 2024
FDA Grants Approval to Caris Life Sciences for MI Cancer Seek; Johnson & Johnson MedTech Secures FDA IDE Approval for OTTAVA; Organogenesis Shares Positive Interim Data from Second Phase 3 Study of ReNu; LivaNova’s OSPREY Trial Achieves Key Safety and Efficacy Milestones; Hyperfine Launches Advanced Portable MR Brain Imaging Swoop® System Across Europe; Nihon Kohden Strengthens Neurological Solutions Through Ad-Tech Medical Instrument Corporation Acquisition
Caris Life Sciences Received FDA Approval for MI Cancer Seek™ as a Companion Diagnostic (CDx) Test On November 6, 2024, Caris Life Sciences, a leading next-generation AI TechBio company and precision medicine pioneer, announced that the U.S. Food and Drug Administration (FDA) approved MI Cancer Seek™ for u...
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Sep 26, 2024
Vivos Therapeutics Receives FDA 510(k) Clearance for Pediatric Sleep Apnea; Nevro Launches AI-Driven Spinal Cord Stimulation; Jupiter Endovascular Treated First Patients in Pulmonary Embolectomy System Study; Toro Neurovascular Advances Stroke Treatment with SuperBore Aspiration Catheter; GE HealthCare Introduces Venue Ultrasound Solutions; Linear Health Expands Orchid Safety Valve Indications
Vivos Therapeutics Received Groundbreaking FDA 510(k) Clearance to Treat Moderate to Severe Pediatric Sleep Apnea and Snoring On September 18, 2024, Vivos Therapeutics, Inc., a premier medical device and technology firm focused on innovative treatments for sleep-related breathing disorders (SRBDs), including obs...
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May 02, 2024
Xtant Medical’s SimipliGraft TM and SimpliMaxTM Launch; Perelel’s Fertility Support Products Expansion; Medtronic’s InceptivTM FDA Approval; GE Healthcare’s Vital Signs Monitor FDA 510(K) Clearance; Merck’s Pneumonia Vaccine Positive Results; Artivion’s Aortic Devices AATS Win
Xtant Medical Announced the Launch of SimipliGraft TM and SimpliMaxTM for Chronic and Acute Wounds On April 30, 2024, Xtant Medical Holdings, Inc., a global medical technology firm specializing in surgical remedies for spinal disorders, announced the complete commercial availability of two amniotic membran...
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May 18, 2023
FDA Approves Abbott’s Spinal Cord Stimulation Systems; Regen Lab Received CE Certification for Three PRP Solutions; Beckman Coulter Launched New Immunoassay Analyser; Shockwave Medical’s Coronary IVL Catheter; Providence Completed Enrollment in the FUSE Clinical Study; Onward Completed First-In-Human Use of Movement-Restoring Lead
Providence Medical Technology Completed Enrolment in the FUSE Clinical Study for High-Risk Cervical Fusion Patients On May 11, 2023, Providence Medical Technology, Inc. (PMT), a leader in medical device innovation for spine surgery, closed the enrolment in its FUSE Study which is a prospective, multicenter...
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