Industry News
72 articles
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.
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.
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.
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.
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.
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.
Bayer-Perfuse $2.45B Deal: Ophthalmology Drug-Device Strategy
Analysis of Bayer's up to $2.45B Perfuse Therapeutics acquisition, including the PER-001 intravitreal implant, deal terms, endothelin mechanism, and ophthalmic drug-device convergence.
GE HealthCare Restructuring, Price Hikes, and MedTech Supply Impact
What GE HealthCare's 2026 restructuring, leadership changes, price increases, and $250M inflation hit mean for medtech supply chains and device manufacturers.
Sun Pharma $11.75B Organon Acquisition: Women's Health and Biosimilars
Sun Pharma's $11.75B Organon deal reshapes women's health and biosimilars. Review deal structure, combination-product considerations, portfolio assets, and regulatory impact.
Danaher's $9.9B Masimo Acquisition: Patient Monitoring and Diagnostics Impact
Analysis of Danaher's $9.9B Masimo acquisition, including deal structure, strategic rationale, antitrust considerations, patient monitoring competition, and medtech industry impact.
EPA Ethylene Oxide Rules for Medical Device Sterilization: 2026 Guide
Guide to the EPA's 2026 proposed EtO emissions rollback for medical device sterilization, covering the 2024 rule, compliance timelines, supply chain risk, and alternatives.
MDUFA VI: FDA Device User Fees and 2027-2032 Reauthorization
Guide to MDUFA VI for 2027-2032, covering FDA device user fee changes, CDRH staffing, real-world evidence provisions, fee projections, and preparation steps.
Medical Device CDMO Market 2026: Growth, Key Players, and Outsourcing
Analysis of the 2026 medical device CDMO market, including growth forecasts, major players, M&A trends, outsourcing drivers, and partner selection criteria.
FDA Workforce Cuts and Medical Device Regulatory Timelines in 2026
How FDA and CDRH staffing reductions may affect 510(k) reviews, pre-submission meetings, MDUFA goals, and regulatory planning for device companies.
EU MDR Notified Body Capacity Crisis 2026-2027: Manufacturer Action Plan
Analysis of EU MDR and IVDR Notified Body capacity using 2026 survey data, review timelines, certification bottlenecks, IVDR Class C risk, and manufacturer actions.
Medical Device Regulatory Sandboxes: MHRA AI Airlock and FDA TEMPO
Guide to medical device regulatory sandboxes, including MHRA AI Airlock, FDA TEMPO for digital health, EU proposals, eligibility, participation, and market access benefits.