United States
287 articles
Boston Scientific-Penumbra $14.5B Deal: Thrombectomy and Neurovascular Strategy
Analysis of Boston Scientific's $14.5B Penumbra acquisition, including CAVT technology, STORM-PE evidence, neurovascular re-entry, competitive impact, and thrombectomy market strategy.
FDA Elsa 4.0 and HALO Platform: Impact on Medical Device Reviews
Guide to FDA Elsa 4.0 and HALO AI modernization, including reviewer tools, data consolidation, submission quality impact, inspection pilots, and how device companies should prepare.
Artivion-Endospan $175M Deal: Nexus Aortic Arch System and FDA PMA
Analysis of Artivion's $175M Endospan acquisition after FDA PMA approval, covering the Nexus Aortic Arch System, TRIOMPHE trial data, portfolio fit, and endovascular market impact.
Medtronic SPR Therapeutics Deal: Neuromodulation for Chronic Pain
Analyze Medtronic's $650 million SPR Therapeutics acquisition, including SPRINT PNS technology, clinical evidence, pain therapy strategy, competition, and market impact.
Connected Autoinjectors and Smart Pens: Drug Delivery Pathways in 2026
Regulatory guide to connected autoinjectors and smart pens, covering FDA 510(k), De Novo, EU MDR classification, SaMD accessory issues, cybersecurity, and human factors.
Boston Scientific-MiRus $1.5B TAVR Investment: SIEGEL Valve Strategy
Analysis of Boston Scientific's $1.5B MiRus investment, the SIEGEL balloon-expandable TAVR system, STAR pivotal trial, rhenium alloy technology, and structural heart market implications.
CMS NTAP Repeal for Breakthrough Devices: FY 2027 IPPS Impact
Guide to CMS's proposed repeal of the NTAP alternative pathway, the new RAPID coverage program, commercialization impact, and next steps for device makers.
FDA Leadership Crisis 2026: Medical Device Regulatory Impact
Analysis of FDA Commissioner Marty Makary's reported May 2026 resignation, leadership departures, workforce losses, device review timeline risks, and manufacturer planning steps.
FDA Section 506J Device Shortage Reporting Guide
Understand Section 506J medical device shortage reporting, including mandatory notifications, the 506J list, OSCR oversight, and supply chain planning.
FDA READI-Home Innovation Challenge: Participation Guide
How medical device companies can join FDA's 2026 READI-Home challenge, including eligibility, phases, Q-submissions, and early engagement benefits.
CIRCIA for Medical Device Manufacturers: Cyber Incident Reporting to CISA
Prepare for CIRCIA cyber incident reporting rules, including 72-hour CISA reports, 24-hour ransomware payment notices, FDA overlap, coverage, and readiness steps.
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.
ASC Expansion 2026: CMS Final Rule and Medtech Commercial Strategy
How the CMS CY 2026 OPPS/ASC Final Rule adds 573 procedures, phases out inpatient-only limits, expands device payment opportunities, and reshapes medtech commercialization.
Single-Use Device Reprocessing and Medtech Sustainability Guide
Assess single-use device reprocessing, circular economy benefits, hospital savings, carbon reduction, AMDR data, lifecycle evidence, EU MDR controls, and business case.
FDA Medical Device Warning Letter Trends 2024-2026: Enforcement Analysis
Data-driven analysis of FDA medical device warning letter trends from 2024 to 2026, including common violations, QMSR shifts, notable actions, and compliance lessons.
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 Cybersecurity Incident Response and Breach Reporting
Build a device cybersecurity response plan covering FDA 21 CFR 806, EU MDR vigilance, CISA timelines, containment, patient safety review, and coordinated disclosure.
Medical Device Design Verification Test Protocol Guide
Write and execute verification test protocols with clear scope, acceptance criteria, sample size rationale, results, and FDA, EU MDR, and ISO 13485 alignment.
DOJ Medical Device Fraud Enforcement 2026: FCA and Anti-Kickback Risks
Guide to DOJ medical device fraud enforcement in 2026, covering False Claims Act exposure, Anti-Kickback Statute compliance, AI-driven investigations, whistleblower risk, and executive controls.