--- title: "Latest MedTech Regulatory & Cybersecurity Updates" description: "Fresh FDA 510(k), PMA, De Novo, recalls, warning letters, PubMed publications, and ClinicalTrials.gov device trials. Per-category RSS feeds. Updated daily." lang: en json-ld: --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About Updated daily · 12:00 UTC # Latest in MedTech FDA 510(k) clearances, PMA approvals, De Novo classifications, recalls, warning letters, PubMed papers, and ClinicalTrials.gov device trials, auto-linked to glossary terms. Subscribe to any single category by selecting it and copying the RSS link. All510(k)PMADe NovoRecallWarningPubMedTrial [All-feed RSS](https://enbnxmvexefleptermbn.supabase.co/functions/v1/feed?format=rss "Subscribe to All-feed RSS")[JSON](https://enbnxmvexefleptermbn.supabase.co/functions/v1/feed?format=json) Tip: click a chip to view that category alone (its RSS link updates). Shift-click to combine multiple. ## Refine Search Glossary term All terms 510(k) Premarket Notification Premarket Approval De Novo Classification Request Substantial Equivalence Predicate Device Quality System Regulation Quality Management System Regulation ISO 13485 ISO 14971 ISO/TR 24971 IEC 62304 Software Safety Classification IEC 62366-1 IEC 60601-1 Essential Performance IEC 60601-1-2 ISO 10993-1 Biocompatibility Software as a Medical Device Software in a Medical Device Clinical Decision Support Refuse to Accept Unique Device Identification EU Medical Device Regulation EU In Vitro Diagnostic Regulation Notified Body CE Mark EUDAMED Corrective and Preventive Action Nonconformance (NCR) Complaint Handling Design Controls Verification & Validation Design History File Device Master Record Device History Record Design Transfer Process Validation Supplier Controls Risk Management File Benefit-Risk Determination Human Factors Engineering Use Error Post-Market Surveillance Periodic Safety 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Follow-Up (IVDR) ### Why no IDE category? FDA treats Investigational Device Exemption (IDE) submissions as confidential under 21 CFR 812.38, there's no public listing or API. IDE activity only surfaces later via clearances, approvals, or trial registrations, which you'll see in the other categories. ### Trends · last 90 days Top product codes No data yet. Most active manufacturers No data yet. ### September 2026 · 10 - PubMed 2026-09-01 [Derivation of evidence-based oral-to-parenteral uncertainty factors for medical device toxicological risk assessment. ](https://pubmed.ncbi.nlm.nih.gov/42107516/) Regulatory toxicology and pharmacology : RTP - PubMed 2026-09-01 [Evaluation of the toxicological screening limit and threshold of toxicological concern in medical device toxicological risk assessment for various patient populations. ](https://pubmed.ncbi.nlm.nih.gov/42092492/) Regulatory toxicology and pharmacology : RTP - Trial 2026-09-01 [Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH) ](https://clinicaltrials.gov/study/NCT07640776) Angiodynamics, Inc. · NOT\_YET\_RECRUITING - Trial 2026-09-01 [Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients ](https://clinicaltrials.gov/study/NCT07545928) University Hospital, Strasbourg, France · NOT\_YET\_RECRUITING [feasibility study](/terms/feasibility-study) - Trial 2026-09-01 [Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy ](https://clinicaltrials.gov/study/NCT07521462) ISISPHARMA · NOT\_YET\_RECRUITING - Trial 2026-09-01 [Spinal Bracing in Adults With Painful Degenerative Scoliosis: a Randomized Controlled Open Trial ](https://clinicaltrials.gov/study/NCT06774898) Assistance Publique - Hôpitaux de Paris · NOT\_YET\_RECRUITING - Trial 2026-09-01 [A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test ](https://clinicaltrials.gov/study/NCT07569913) bioLytical Laboratories · NOT\_YET\_RECRUITING - Trial 2026-09-01 [My MS Toolkit: An Internet-Based Depression Self-Management Program for Adults Living With Multiple Sclerosis ](https://clinicaltrials.gov/study/NCT07636434) University of Washington · NOT\_YET\_RECRUITING - Trial 2026-09-01 [Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders ](https://clinicaltrials.gov/study/NCT07613944) Vrije Universiteit Brussel · NOT\_YET\_RECRUITING - Trial 2026-09-01 [Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization ](https://clinicaltrials.gov/study/NCT07304102) W.L.Gore & Associates · NOT\_YET\_RECRUITING ### August 2026 · 6 - PubMed 2026-08-01 [The intelligent ear: AI and hearing aids information seeking and users' discussion on social media. ](https://pubmed.ncbi.nlm.nih.gov/42190300/) Patient education and counseling - PubMed 2026-08-01 [Co-assembly of zwitterionic and cationic polymers for antibacterial and antithrombotic surfaces via weak electrostatic interactions. ](https://pubmed.ncbi.nlm.nih.gov/41795405/) Biomaterials - PubMed 2026-08-01 [Reproducibility of accelerated fatigue test of dentin-composite discs under cyclic diametral compression. ](https://pubmed.ncbi.nlm.nih.gov/41862357/) Dental materials : official publication of the Academy of Dental Materials - PubMed 2026-08-01 [An open-source microphysiological system for the evaluation of cardiovascular materials and devices under controlled flow conditions. ](https://pubmed.ncbi.nlm.nih.gov/41924823/) Biomaterials advances - Trial 2026-08-01 [HILT vs ESWT in Supraspinatus Tendinitis ](https://clinicaltrials.gov/study/NCT07615920) Kafrelsheikh University · NOT\_YET\_RECRUITING - Trial 2026-08-01 [Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery ](https://clinicaltrials.gov/study/NCT07167199) Inova Health Care Services · NOT\_YET\_RECRUITING ### July 2026 · 24 - Trial 2026-07-31 [Water Vapor Ablation for Grade Group 3 Prostate Cancer ](https://clinicaltrials.gov/study/NCT07652164) Francis Medical Inc. · NOT\_YET\_RECRUITING - Trial 2026-07-31 [The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage ](https://clinicaltrials.gov/study/NCT06443177) University of Alabama at Birmingham · NOT\_YET\_RECRUITING - Trial 2026-07-15 [Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants ](https://clinicaltrials.gov/study/NCT06373289) University of Alabama at Birmingham · RECRUITING - Trial 2026-07-02 [Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients ](https://clinicaltrials.gov/study/NCT07594678) Ohio State University Comprehensive Cancer Center · NOT\_YET\_RECRUITING - PubMed 2026-07-01 [Shared inflammatory targets of phthalate plasticizers in MODS-related syndromes: An integrative network toxicology study with representative DEHP in vitro validation. ](https://pubmed.ncbi.nlm.nih.gov/42107545/) Toxicology and applied pharmacology - PubMed 2026-07-01 [Medical Device-Related Pressure Injuries: A Systematic Review for Prevalence, Causes, and Risk Factors Since the COVID-19 Pandemic. ](https://pubmed.ncbi.nlm.nih.gov/42155083/) Advances in skin & wound care [wound care](/terms/wound-care) - PubMed 2026-07-01 [Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. ](https://pubmed.ncbi.nlm.nih.gov/41967377/) Social science & medicine (1982) - PubMed 2026-07-01 [The small interfering RNA imdusiran as single and multiple doses in healthy, randomised individuals and non-randomised individuals with chronic hepatitis B (AB-729-001): a phase 1a/b trial. ](https://pubmed.ncbi.nlm.nih.gov/42173110/) The lancet. Gastroenterology & hepatology - PubMed 2026-07-01 [Diagnostic performance of AI-based EEG interpretation versus human clinical experts for epilepsy detection: systematic review and meta-analysis. ](https://pubmed.ncbi.nlm.nih.gov/41956141/) Journal of biomedical informatics - Trial 2026-07-01 [Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer ](https://clinicaltrials.gov/study/NCT07645118) Dr. Te Vuong · NOT\_YET\_RECRUITING - Trial 2026-07-01 [Nd:YAG vs Alexandrite Laser Treatment in Hidradenitis Suppurativa ](https://clinicaltrials.gov/study/NCT06960447) Geisinger Clinic · NOT\_YET\_RECRUITING - Trial 2026-07-01 [EASEE® System Pivotal Study for the United States of America ](https://clinicaltrials.gov/study/NCT07301346) Precisis US, Inc. · NOT\_YET\_RECRUITING - Trial 2026-07-01 [A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure ](https://clinicaltrials.gov/study/NCT07353710) Boston Scientific Corporation · NOT\_YET\_RECRUITING - Trial 2026-07-01 [High-Flow Nasal Cannula After Major Abdominal Surgery to Prevent Postoperative Pulmonary Complications ](https://clinicaltrials.gov/study/NCT07528404) Uijeongbu St. Mary Hospital · NOT\_YET\_RECRUITING - Trial 2026-07-01 [Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction ](https://clinicaltrials.gov/study/NCT07339215) University of California, Davis · NOT\_YET\_RECRUITING - Trial 2026-07-01 [Efficacy of Activator Trigger Point and Shock Wave Therapy on Pain and Function in Active Upper Trapezius Trigger Points: A Randomized Controlled Study ](https://clinicaltrials.gov/study/NCT07594223) Cairo University · NOT\_YET\_RECRUITING - Trial 2026-07-01 [Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis ](https://clinicaltrials.gov/study/NCT07574918) Aerin Medical · NOT\_YET\_RECRUITING - Trial 2026-07-01 [Effects of Low-Load Blood Flow Restriction Exercise on Rectus Femoris Muscle Morphology in Individuals With Relapsing-Remitting Multiple Sclerosis ](https://clinicaltrials.gov/study/NCT07645937) Hanifi Bal · NOT\_YET\_RECRUITING - Trial 2026-07-01 [The Effect of Static Magnetic Fields on Neuroinflammation in Migraine ](https://clinicaltrials.gov/study/NCT07584382) Marco Loggia · NOT\_YET\_RECRUITING - Trial 2026-07-01 [Photobiomodulation, Heart Rate Variability, and Acute Stress ](https://clinicaltrials.gov/study/NCT07475858) Brigham and Women's Hospital · NOT\_YET\_RECRUITING - Trial 2026-07-01 [A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System ](https://clinicaltrials.gov/study/NCT07477054) Lungpacer Medical Inc. · NOT\_YET\_RECRUITING - Trial 2026-07-01 [Spinal Cord Stimulation for Refractory Pain Randomized Controlled Trial: the PAcStim RCT ](https://clinicaltrials.gov/study/NCT07468591) University Health Network, Toronto · NOT\_YET\_RECRUITING - Trial 2026-07-01 [TENS in Nocturnal Enuresis ](https://clinicaltrials.gov/study/NCT07594353) Suez Canal University · NOT\_YET\_RECRUITING - Trial 2026-07-01 [Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS) ](https://clinicaltrials.gov/study/NCT07501442) Wooshin Labottach Co., Ltd. · NOT\_YET\_RECRUITING ### June 2026 · 10 - Trial 2026-06-22 [Efficacy of Sub-laminar and/or Interspinous Tethers to Prevent Proximal Junctional Kyphosis After Surgical Correction of Adult Spinal Deformity ](https://clinicaltrials.gov/study/NCT07618897) Hospices Civils de Lyon · NOT\_YET\_RECRUITING - Trial 2026-06-22 [Effect of High-Intensity Focused Electromagnetic Therapy on Balance and Quality of Life in Patients With Multiple Sclerosis ](https://clinicaltrials.gov/study/NCT07646912) Middle East University · NOT\_YET\_RECRUITING - Trial 2026-06-20 [Efficacy and Mechanism of 'Yanjiu Needle' for Pharyngeal Dysphagia Based on sEMG Features ](https://clinicaltrials.gov/study/NCT07656025) The Third People's Hospital of Huizhou · NOT\_YET\_RECRUITING - Trial 2026-06-20 [Evaluating a Text-Prompt AI Assistant for Chest CT Scans (AI-REPORT Study) ](https://clinicaltrials.gov/study/NCT07634861) Shanghai Zhongshan Hospital · RECRUITING - PubMed 2026-06-19 [Beyond snapshot dosing: a dynamic living digital twin framework for model-informed precision dosing in critical illness. ](https://pubmed.ncbi.nlm.nih.gov/42318854/) Expert review of clinical pharmacology - PubMed 2026-06-19 [Regulating digital surgery to balance safety and innovation: a SAGES white paper. ](https://pubmed.ncbi.nlm.nih.gov/42321466/) Surgical endoscopy - PubMed 2026-06-19 [The Shifting Geography of Innovation in Endourology. ](https://pubmed.ncbi.nlm.nih.gov/42321068/) European urology - PubMed 2026-06-18 [Improving Infection Control in Nursing Homes: Enhanced Barrier Precautions and MDRO Colonization. ](https://pubmed.ncbi.nlm.nih.gov/42314874/) American journal of infection control - PubMed 2026-06-18 [Knowledge gaps in pressure injury, medical device-related pressure injury, and skin tear among intensive care unit nurses. ](https://pubmed.ncbi.nlm.nih.gov/42316156/) BMC nursing - PubMed 2026-06-18 [Custom Made Three Dimensional Printed Models for Pre-operative Planning and Simulation of Endovascular Treatment of Peripheral Artery Disease (3DPAD-1): A Single Blind Randomised Controlled Trial. ](https://pubmed.ncbi.nlm.nih.gov/42314902/) European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery Admin · trigger manual ingest Admin token Run ingest now Triggers the ingest job with AI summaries. 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