MedDeviceGuide — IVD & Medical Device Knowledge Base
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.
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.
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.
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.
EU MDR Article 10a: Supply Chain Discontinuation and Shortage Prevention
Learn when manufacturers must report device interruptions under EU MDR Article 10a, who to notify, required data, supply chain flow, and 2026 guidance.
EU MIR Form 7.3.1 Mandatory Update: What Changed From Version 7.2.1 and How to Prepare
Prepare for EU MIR Form 7.3.1, mandatory from May 1, 2026, including changes from 7.2.1, reportability fields, UDI issuing entity selection, EUDAMED XML, and vigilance updates.
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.
EU MDR Article 59 National Derogation: CE Marking Exemptions
Practical guide to MDR Article 59 national derogations, including when non-CE-marked devices may be authorized, how reviews work, and manufacturer strategy.
EU Reference Laboratories for IVDR Class D IVDs: EURL Guide
Guide to EU Reference Laboratories under IVDR Article 100 for Class D IVDs, including rollout, affected categories, performance verification, batch testing, and manufacturer preparation.
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.
Ecuador ARCSA Medical Device Registration Guide: 2026 Requirements
Guide to Ecuador ARCSA registration for medical devices and IVDs under the April 2026 rules, covering classification, documentation, fees, timelines, and post-market obligations.