Clinical Evidence
50 articles
FDA Dermal Filler Approvals and Adverse Events: A 30-Year MAUDE and PMA Analysis
A comprehensive, data-driven analysis of 1,038 FDA dermal filler PMA approvals and 22,247 adverse events from the MAUDE database, detailing trends, top brands, and safety profiles.
Investigational Device Rules Compared: FDA 21 CFR 812, EU MDR, SFDA & Health Canada
Side-by-side comparison of investigational device rules: FDA 21 CFR Part 812 IDE, EU MDR Articles 62-82, Saudi SFDA MDS-REQ 2, and Canada's Investigational Testing Authorization.
FDA Prior Knowledge Framework for Cell and Gene Therapy: Draft Guidance June 2026
FDA's June 2026 draft guidance on reusing CMC, nonclinical, and clinical prior knowledge to accelerate gene therapy development, and its interaction with the Plausible Mechanism Framework.
Quantum Surgical Acquires NeuWave Medical: Precision IO and Robotic Ablation
Quantum Surgical's 2026 NeuWave acquisition pairs Epione robotic ablation with microwave ablation technology under Precision IO Group for interventional oncology.
Endologix Acquires Surmodics Pounce Thrombectomy System
Analysis of Endologix's May 2026 Pounce thrombectomy acquisition from Surmodics, covering the device, PAD market fit, FTC context, and vascular M&A impact.
FDA Weight Loss Device Guidance 2026: Premarket Evidence Guide
Review FDA's 2026 weight loss device guidance, including clinical study design, benefit-risk analysis, nonclinical testing, and obesity device strategy.
Medical Device Clinical Trial Diversity: FDA Action Plan Guide
How device sponsors can prepare FDA Diversity Action Plans under FDORA, set enrollment goals, address waiver criteria, and support representative clinical studies.
Medical Device AI Bias Testing: Fairness Validation and Documentation
How to test AI-enabled medical devices for demographic bias, validate fairness statistically, document FDA and EU submissions, and monitor post-market performance.
Medical Device Clinical Trial Cost: 2026 Budget Breakdown
2026 medical device clinical trial cost guide covering per-patient costs, site fees, CRO budgets, IDE preparation, monitoring, pivotal studies, and cost-saving strategies.
FDA Patient Preference Information for Medical Devices: 2026 Final Guidance
Guide to FDA Patient Preference Information for medical devices under the 2026 final guidance, including collection methods, validation, regulatory submissions, benefit-risk use, and EU alignment.
SaMD Clinical Evaluation: Clinical Evidence for FDA and EU MDR Submissions
Guide to SaMD clinical evaluation, covering valid clinical association, analytical validation, clinical performance, FDA expectations, EU MDR evidence, and real-world data.
W.L. Gore Acquires Conformal Medical: LAAO Market Analysis
Analysis of W.L. Gore's Conformal Medical acquisition, CLAAS AcuForm LAAO technology, structural heart competition, pivotal trial status, and market impact.
Medtronic CathWorks and Scientia Deals: Cardiovascular and Neurovascular
Review Medtronic's 2026 CathWorks and Scientia Vascular deals, covering FFRangio coronary diagnostics, neurovascular access technology, deal value, and tuck-in M&A strategy.
CareDx-Naveris $260M Deal: Liquid Biopsy and Oncology Diagnostics Strategy
Analysis of CareDx's up to $260M Naveris acquisition, NavDx liquid biopsy technology, TTMV DNA biomarker strategy, transplant-to-oncology pivot, and molecular residual disease market impact.
J&J Atraverse Acquisition: Cardiac Ablation Access Technology and EP M&A
Analysis of J&J's April 24, 2026 Atraverse Medical acquisition, covering HOTWIRE transseptal access, RF guidewire technology, Biosense Webster strategy, and the cardiac ablation M&A landscape.
Stryker Acquires Amplitude Vascular Systems: IVL and Peripheral Vascular Strategy
Stryker's May 2026 AVS acquisition adds next-generation IVL for calcified PAD, including the CO2 pressure wave platform, regulatory path, competition, and market impact.
EU Breakthrough Device (BtX) Designation: MDCG 2025-9 and EMA Pilot Guide
Guide to the EU BtX framework under MDCG 2025-9, covering eligibility, application steps, EMA pilot benefits, FDA comparisons, and IVD implications.
FDA Real-Time Clinical Trials Pilot for Medical Devices
What device sponsors need to know about FDA's 2026 real-time clinical trials pilot, AI-enabled monitoring, Paradigm Health, and participation readiness.
Auto-Injector Critical-Task Matrix for Human Factors Validation
Guide to auto-injector critical-task matrices for human factors validation, including URRA inputs, dose confirmation, hold time, misfire recovery, training decay, and FDA evidence expectations.
IVDR Companion Diagnostic Consultation File: NB-EMA/NCA Package Guide
Prepare an IVDR companion diagnostic consultation file for NB submission, covering EMA/NCA review, contents, performance evidence, drug label alignment, timing, and deficiency risks.