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Industry News

72 articles

Industry News

Stryker Handala Cyberattack 2026: MedTech Supply Chain and Cybersecurity Lessons

Analyze the March 2026 Handala wiper attack on Stryker, its global manufacturing and order disruption, supply chain impact, and cybersecurity lessons for medtech.

Regulatory

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

Industry News

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

M&A & Funding

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.

Regulatory

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.

M&A & Funding

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.