United States
287 articles
Liquid Biopsy and Multi-Cancer Early Detection (MCED) Tests: FDA, IVDR Regulatory Pathway
Regulatory guide to liquid biopsy and MCED tests, including FDA pathways, Breakthrough designation, companion diagnostics, EU IVDR classification, clinical evidence, and key market players.
FDA TEMPO Pilot for Digital Health Devices and CMS ACCESS
Guide to FDA's TEMPO pilot for digital health devices, enforcement discretion, real-world evidence, CMS ACCESS alignment, eligibility, and key dates.
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.
FDA 510(k) Exemptions for Class II Devices: 2026 Product Code Changes
Guide to 2026 FDA 510(k) exemption proposals and final notices for Class II devices, including affected product codes, exemption limits, criteria, and manufacturer next steps.
FDA Bone Growth Stimulator Reclassification 2026: Class III to II
Guide to FDA's 2026 reclassification of non-invasive bone growth stimulators from Class III to Class II, including special controls, 510(k) impact, CMS billing updates, and manufacturer implications.
Medical Device Reshoring and Nearshoring Strategy Guide (2026)
Evaluate medical device reshoring and nearshoring decisions in 2026, including tariffs, QMSR and ISO 13485 implications, cost trade-offs, supply risk, and IP protection.
Avanos Medical AIP $1.27B Take-Private: Medtech Deal Analysis
Analysis of AIP's $1.27B Avanos Medical take-private deal, including nutrition and pain management franchises, NOPAIN Act tailwinds, deal terms, and private equity signals for medtech.