MedTech Industry Pulse: May 2026

BioWorld’s monthly tracker shows April 2026 financings at $1.51B, continuing a slowdown since the $8.23B peak in December 2025. BioWorld’s tracker spans IPOs, follow-ons, private placements, venture rounds, and loans for companies developing medical devices, diagnostics, and related technologies, and excludes grants and money received through acquisitions, partnerships, or licensing deals.

MiRus received a $1.5B strategic investment from Boston Scientific tied to TAVR (transcatheter aortic valve replacement), the largest single funding event of the month by a wide margin.

The comment window on a proposal to repeal the NTAP alternative pathway closes June 9. The change would end the Breakthrough Device add-on payment pathway effective FY 2028, raising the evidence bar for reimbursement, a shift worth building into any market access and reimbursement strategy for FY2028 launches. CMS’s proposed FY2027 inpatient rule is also under review, introducing device NTAP approvals and a first UDI-for-implants reporting measure for hospitals. In the EU, device Health Technology Assessment launches in June, with the first EU Joint Clinical Assessments covering high-risk devices and Class D IVDs.

AI entered FDA inspections on May 6, with the agency piloting one-day, AI-informed assessments of lower-risk facilities to shift inspection resources toward higher-risk sites. The EU AI Act’s Digital Omnibus deal, reached May 7, keeps medical devices subject to high-risk AI requirements even as industrial AI won an exemption, though device obligations are deferred to August 2028. EUDAMED became mandatory May 28, intensifying the EU’s push for device transparency and supply chain visibility. Together, these changes are another reason regulatory strategy and submissions planning needs to account for cross-border reliance pathways early, not after a submission is already in progress.

FDA Commissioner Makary resigned May 12, and Kyle Diamantas, the agency’s food chief and a lawyer, became acting commissioner pending a Senate-confirmed nominee. FDA launched its AI-assisted inspection pilot May 6, completing 46 assessments by late April, mostly resulting in No Action Indicated outcomes. Human Factors guidance was finalized May 28, setting new content expectations for 510(k), De Novo, PMA, and HDE submissions. Coverage pathways are also shifting, with the RAPID pathway now live and comments on the NTAP alternative-pathway repeal closing June 9.

EUDAMED became mandatory May 28, requiring new MDR and IVDR devices to be registered in the UDI or Device module before market placement, with all economic operators needing an SRN. The AI Act Digital Omnibus deal, reached May 7, keeps medical devices subject to high-risk AI requirements while granting industrial AI an exemption, and defers device obligations to August 2028. Refreshed classification guidance, MDCG 2021-24 Rev 1, along with new post-market surveillance guidance, shapes how device records map into EUDAMED.

The MHRA published draft Medical Devices Regulations May 8 and notified them to the WTO, moving toward closer alignment with EU MDR and IVDR along with mandatory UDI and implant cards. The draft proposes an international reliance route for streamlined GB access for devices already approved in the US, Canada, or Australia, plus a Predetermined Change Control Plan pathway allowing pre-defined SaMD changes without full re-certification. An impact survey is open until June 19, with adoption expected in December 2026.

Health Canada’s Terms and Conditions powers are now active, letting the agency impose or amend license conditions at any point in a device’s lifecycle. The Regulatory Enrolment Process, now mandatory and aligned with IMDRF, replaced email filings for Class II to IV devices, and submissions now use the IMDRF Table of Contents. Significant-change and AI thresholds have also tightened, with clinical evidence now assessed across the full device lifecycle.

A unified biomedical technologies rule covering stem cells and gene editing took effect May 1, applicable to foreign-invested institutions. Export certificate reform also took effect May 1, introducing a two-tier system: Type I for China-registered devices and Type II for unregistered devices meeting GMP. NMPA’s 2026 plan adds more than 80 new and revised standards, continuing to deepen ISO alignment and AI oversight.

Japan began recognizing FDA as an equivalent authority May 1, giving US-registered devices with a Japanese predicate priority review and expanding conditional approval pathways. Australia’s TGA opened a supply-resilience reliance pathway May 1, allowing it to authorize devices already cleared in the EU, US, UK, Canada, or Japan to address shortages, with UDI requirements starting July 1. ASEAN reliance programs continue to broaden across Class B through D devices, and New Zealand maintains its TGA-aligned approach.