MedDeviceGuide — IVD & Medical Device Knowledge Base

Analysis of Abbott's $21B Exact Sciences acquisition, including Cologuard, Oncotype DX, deal structure, cancer screening IVD strategy, and precision oncology market impact.

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.

Review Haemonetics' Vivasure acquisition, PerQseal Elite bioabsorbable closure technology, PMA pathway, CE Mark status, ELITE data, and large-bore closure competition.

Analysis of Embecta's Owen Mumford acquisition, including deal terms, Aidaptus auto-injector technology, diabetes business diversification, and GLP-1 drug-device strategy.

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's confidential 2026 IPO filing, $11B valuation, wearable health platform strategy, and what its public-market move signals for medtech.

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.

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.

Evaluate medical device reshoring and nearshoring decisions in 2026, including tariffs, QMSR and ISO 13485 implications, cost trade-offs, supply risk, and IP protection.

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.

Analysis of Boston Scientific's $14.5B Penumbra acquisition, including CAVT technology, STORM-PE evidence, neurovascular re-entry, competitive impact, and thrombectomy market strategy.

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.

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.

Analysis of how Iran conflict and Strait of Hormuz disruption could affect medical device supply chains, including helium, plastics, freight, insurance, and sourcing strategy.

Analyze Medtronic's $650 million SPR Therapeutics acquisition, including SPRINT PNS technology, clinical evidence, pain therapy strategy, competition, and market impact.

Regulatory guide to connected autoinjectors and smart pens, covering FDA 510(k), De Novo, EU MDR classification, SaMD accessory issues, cybersecurity, and human factors.

Learn when manufacturers must report device interruptions under EU MDR Article 10a, who to notify, required data, supply chain flow, and 2026 guidance.

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.

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.

Guide to CMS's proposed repeal of the NTAP alternative pathway, the new RAPID coverage program, commercialization impact, and next steps for device makers.