Global
197 articles
FTC Blocks Edwards' $945M JenaValve Deal: Medical Device Antitrust
Analysis of the FTC injunction blocking Edwards' JenaValve acquisition, the TAVR-AR innovation market theory, court ruling, and medtech M&A implications.
Waters-BD Biosciences $18.8B Merger: Life Science Tools Deal Guide
Analysis of Waters' $18.8B BD Biosciences combination, covering deal structure, analytical platforms, diagnostics synergies and impact on device and IVD manufacturers.
Boston Scientific-Bolt $900M Deal: IVL Market and FDA Strategy
Analysis of Boston Scientific's up to $900M Bolt Medical acquisition, laser-based IVL technology, FDA 510(k) pathway, RESTORE and FRACTURE trials, Shockwave competition, and calcified artery market.
J&J DePuy Synthes Sale: Orthopedics Divestiture and MedTech Spinoff Guide
Analysis of J&J's DePuy Synthes separation and potential $20B+ sale, covering the 2025-2027 timeline, orthopedics revenue, VELYS robotics, buyer options, and medtech divestiture trends.
Stryker Inari Medical $4.9B Deal: VTE Thrombectomy Market Analysis
Stryker's $4.9B Inari Medical acquisition adds FlowTriever and ClotTriever platforms. Review deal structure, VTE thrombectomy competition, FDA pathways, and commercialization impact.
DePuy Synthes Gemtrack RF Tracking Deal: Orthopedic Robotics Impact
Analysis of DePuy Synthes' Gemtrack RF tracking deal, including VELYS strategy, competition with Mako and ROSA, J&J portfolio options, orthopedic robotics growth, and regulatory considerations.
IV-to-Subcutaneous Shift: OBDS Regulatory Strategy Guide (2026)
Analysis of the IV-to-subcutaneous shift in biologics, covering on-body delivery systems, OBDS combination product pathways, human factors, and market drivers.
Olympus Acquires BioProtect for $270M: Balloon Spacer Market and Strategy
Analysis of Olympus's $270M BioProtect acquisition, including balloon spacer technology, prostate cancer radiation use, FDA 510(k) strategy, competitors, and commercialization impact.
Abbott-Exact Sciences $21B Deal: Cancer Diagnostics and IVD Strategy
Analysis of Abbott's $21B Exact Sciences acquisition, including Cologuard, Oncotype DX, deal structure, cancer screening IVD strategy, and precision oncology market impact.
Boston Scientific-Nalu $600M Deal: Peripheral Nerve Stimulation Strategy
Analysis of Boston Scientific's $600M Nalu Medical acquisition, battery-free PNS implants, COMFORT trial data, neuromodulation competition, FDA pathway, and chronic pain market shift.
Haemonetics Acquires Vivasure Medical: Vascular Closure Deal Guide
Review Haemonetics' Vivasure acquisition, PerQseal Elite bioabsorbable closure technology, PMA pathway, CE Mark status, ELITE data, and large-bore closure competition.
Embecta-Owen Mumford $201M Deal: Auto-Injectors and Drug Delivery
Analysis of Embecta's Owen Mumford acquisition, including deal terms, Aidaptus auto-injector technology, diabetes business diversification, and GLP-1 drug-device strategy.
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.
Oura IPO at $11B: MedTech Impact of the Smart Ring Listing
Oura's confidential 2026 IPO filing, $11B valuation, wearable health platform strategy, and what its public-market move signals for medtech.
Iran War Impact on Medical Device Supply Chains and Strait of Hormuz Risk
Analysis of how Iran conflict and Strait of Hormuz disruption could affect medical device supply chains, including helium, plastics, freight, insurance, and sourcing strategy.
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.
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.