Eight MedTech innovators, spanning organ perfusion, surgical robotics, Software as a Medical Device, AI-driven imaging, and more, chose Enlil's AI-powered traceability platform in Q1 2026, migrating off legacy quality and PLM systems, including Greenlight Guru and PTC Arena, and going live in a matter of weeks.

CAMPBELL, Calif., May 14, 2026 /PRNewswire/ -- Enlil, the AI-powered development traceability platform built for medical device and life sciences organizations, today announced a record first quarter of 2026, signing eight new customers in just three months. The Q1 2026 cohort represents a broad range of MedTech segments, from cardiovascular and vascular technology to surgical innovation, organ perfusion, kidney care, women's health, and AI-driven imaging, and signals a clear pattern: medical device teams are moving away from siloed quality and product lifecycle tools and standardizing on a single, integrated platform built for the way modern MedTech actually develops products.

The new Q1 2026 customers include Vascular Perfusion Solutions, Verionyx (formerly FBR Medical), and iSono Health. Most of the cohort came to Enlil with substantial existing product development data and were migrating from legacy point-solution quality and product lifecycle systems — work that involves reconciling multiple data sources, including data from competitor platforms, and standing up new processes without disrupting active development programs. Enlil's dedicated migration team worked closely with each customer to ensure a smooth and rapid onboarding experience.

Eight Decisions, One Pattern

Across the Q1 2026 cohort, five themes emerged consistently in customers' decisions to standardize on Enlil:

• Flexibility. The ability to easily build custom forms and workflows that match each company's actual processes, rather than being shoehorned into a vendor's pre-configured structure.
• Culture. New customers consistently report a positive experience working with a vendor that understands the growing pains of a rapidly iterating MedTech startup.
• An integrated solution. Quality, product lifecycle, parts, build lots, procurement, and supplier management on a single platform, not siloed tools that each cover only a slice of quality or PLM data.
• Private AI that isn't limited by siloed data. AI is only as useful as the data foundation underneath it. By combining a single source of truth across the entire product development lifecycle with an AI-first architecture, Enlil delivers AI that can reason across requirements, design outputs, risk, and verification — not just generate confident-sounding output from fragmented inputs.
• Integration with existing tech. Two-way integrations with key engineering and operations tools — including SolidWorks, Onshape, and Bill.com — are critical to reduce the downstream ECO and change-management issues that arise when mechanical CAD and quality systems aren't connected.

"Today's MedTech teams move faster than the legacy systems holding them back, and that gap is where the industry's hidden costs live," said Nader Fathi, CEO of Enlil. "Eight new customers in 90 days, replacing legacy systems with rapid go-lives, reflects what's possible when teams get a platform built for the way they truly work. We are proud of what the Enlil team has accomplished — and even more excited to partner with MedTech innovators building devices that are enhancing and saving lives. That mission is what drives us, and it's the bar we intend to keep raising."

In Their Own Words

"Vascular Perfusion Solutions is bringing fundamentally new perfusion technology to organ preservation, and that means our quality and product systems need to keep pace with rapid engineering and clinical iteration. We needed a platform we could shape for our processes, not the other way around, and a partner who understood what it means to support a lean, fast-moving MedTech company. Enlil delivered on both, and we were implemented faster than we thought possible," said Dr. Rafael Veraza, PhD, MPH, CEO of Vascular Perfusion Solutions.

"We are in a great spot. Our rollout of the quality system is complete, and the team is trained. We have also released our first non-quality-system documents, and the team loves Enlil so far. I have found it to be as intuitive and usable as it seemed in the demos," said Trey Bobo, Chief Operating Officer of Verionyx.

"Breast cancer kills women who were never screened, not because the technology to detect it didn't exist, but because the care system wasn't built for where women actually receive care. iSono Health is changing that. We built the world's first wearable, automated quantitative ultrasound platform for breast imaging, designed to bring consistent, data-rich breast imaging closer to the point of care, without requiring a specialized imaging suite. To scale something this innovative and ambitious without compromising on quality or regulatory rigor, you need infrastructure that matches our rigor. Enlil does! giving us one connected foundation for traceability, quality, and change management, built by people who share our urgency to get advanced healthcare technology to more women, sooner," said Neda Razavi, CEO & Chairwoman of iSono Health.

Building on Q1 Momentum: An AI-First Foundation for the Next Phase of MedTech

Enlil's Q1 2026 momentum rests on an AI-first foundation defined by a single principle: when quality, PLM, requirements, risk, procurement, and manufacturing data live on a unified layer, AI can do work that fragmented legacy QMS and PLM systems cannot. That foundation enables Ask Lily, Enlil's cross-cutting AI capability, to deliver discovery and insight across the full product lifecycle. It also powers purpose-built agents like Milestone View and Change Impact and accelerates customer onboarding even across complex migrations from legacy systems. Operating securely within AWS Bedrock with multi-model access and MCP integrations, Enlil's architecture is built for the regulated reality of medical device development — traceable by design and engineered to make AI a genuine accelerator of compliance rather than another source of risk.

Note: all third-party product and company names are trademarks or registered trademarks of their respective owners.

About Enlil`
Enlil is a cloud-native AI-driven development traceability platform built for medical device and life sciences organizations. Designed to support regulatory readiness across the product lifecycle, Enlil connects quality, regulatory, R&D, manufacturing, and operations teams around a unified system of record. By structuring product data for traceability, auditability, and real-time visibility, Enlil helps MedTech innovators manage complexity, reduce risk, and scale compliance from concept through commercialization. Learn more at enlil.com.

Media Contacts
Christine Pearsall, Director of Marketing, Enlil
christine@enlil.com

Sandra Schwartzman, Vice President of Public Relations, RMR & Associates
sschwartzman@rmr.com

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SOURCE Enlil, Inc.