About SEVA Devices

A different kind of disposables company.

SEVA Devices supplies OEM-grade contrast injector syringes and disposables direct to radiology departments, manufactured to the same standards as the OEM products your department has relied on for decades. No bundling, no proprietary lock-in, no contracting friction.

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Direct

Sold direct. No distributor markup. No contrast bundling.

OEM

Same manufacturing standards as the products you already trust

U.S.

Operations based in the U.S. European expansion planned

SEVA Positioning Statement

SEVA Devices supplies the contrast injector syringes and disposables your radiology department relies on, manufactured to the same standards as OEM products, produced by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables, and sold direct to imaging operations on a single transparent contract, free of the bundling, proprietary lock-ins, and contracting friction that define OEM relationships. SEVA exists so that Radiology Administrators can stop thinking about contrast disposables and get back to running their departments.

The Company

Built to solve a specific problem.

Radiology departments were paying OEM prices for contrast disposables — supplied through contracts they could not leave or negotiate, and bundled with contrast media they did not need. SEVA was built to change that.

SEVA Devices was co-founded by Denny Durmis and Rakesh Amin to address a structural inefficiency in the U.S. radiology disposables market. Across the major OEMs — Bayer, Bracco, Guerbet, GE, and Nemoto — the market has increasingly consolidated around proprietary platforms and bundled contracts that tie injector disposables to contrast media purchases. The clinical performance of the disposables themselves is largely equivalent across generations. The commercial terms are not.

SEVA competes on manufacturing pedigree, not price.

SEVA's structural advantage is manufacturing pedigree. SEVA products are produced by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables. That sets SEVA apart from low-cost competitors that compete primarily on price without comparable manufacturer credentials.

The business sells direct. Contracts with imaging centers, hospitals, and IDNs are written clean and transparent — one product, with your contrast and capital each decided on their own terms, clear of the proprietary lock-ins that follow every Bayer, Bracco, or Guerbet capital upgrade. All customer service stays SEVA-branded.

Because SEVA does only this — disposables, not injectors, capital equipment, or contrast — it carries none of the overhead an OEM folds into every kit: no injector line to fund, no capital sales force, no global service apparatus riding on the price. The manufacturing pedigree is identical. The corporate structure behind the price is not — and that difference, not a lesser product, is where the savings come from.

SEVA currently operates in the U.S. market. European expansion is planned, with timing to be confirmed. The site and operational infrastructure are built to support international customers without structural rework.

सेवा

SEVA.

Sanskrit · सेवा

Selfless service.

The name is drawn from the Sanskrit word seva, meaning selfless service, with a particular emphasis on service directed toward others rather than oneself. In its oldest sense it describes care rendered without expectation of return.

That principle shapes how SEVA operates. Radiology departments should not have to negotiate, worry, or think about their contrast disposables. The supply should simply work. The pricing should be fair. The service should be invisible in the best possible sense. That is what selfless service looks like in a radiology department.

Why SEVA

Three things no other non-OEM supplier can say.

Hundreds of companies sell contrast injector disposables. Very few can make all three of these claims simultaneously.

01 · Manufacturing

OEM-grade pedigree.

Manufactured by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables. Same GMPs, same particulate controls, same regulatory framework as the OEM products your department already uses.

02 · Commercial

No bundling. No lock-in.

Capital, contrast, and disposables stay three separate decisions — never one bundled package. SEVA sells the disposable, direct, with transparent pricing. Your injectors and contrast relationships stay exactly as they are.

03 · Regulatory

Every credential is verifiable.

FDA 510(k) cleared. ISO 13485:2016 certified. EU MDR compliant. CE marked. Every credential has a document behind it. K-numbers, certificates, declarations of conformity, and product specifications are available to qualified buyers and VAC reviewers on request.

Manufacturing Pedigree

The supply chain behind the syringe.

Manufacturing provenance is SEVA's strongest single credential. It is the fact that separates SEVA from every other non-OEM supplier in the U.S. market, and it is stated plainly rather than buried in fine print.

The Provenance Claim

Same manufacturer. Same standards.

SEVA products are manufactured by the same global contract manufacturer that supplies a major European manufacturer of injector consumables and disposables. This claim is accurate, substantiated, and verifiable by qualified supply chain reviewers on request.

What This Means in Practice

Same GMPs. Same particulate controls. Same framework.

The manufacturing controls that define OEM-grade quality are codified in regulations and standards, not proprietary to any single company. SEVA's products are manufactured to 21 CFR Part 820, EU MDR GMP requirements, ISO 13485:2016, ISO 10993 biocompatibility, ISO 11135 sterilization validation, and the same particulate specifications applied to OEM contrast injector syringes.

How It Differs from Competitors

Manufacturing pedigree, not price.

Low-cost competitors, including suppliers based in Shenzhen, Wuxi, and other manufacturing centers, compete primarily on price. SEVA does not. Manufacturing pedigree shared with a major European OEM supplier is a structural difference, not a marketing claim, and it determines where SEVA competes and how SEVA prices.

Leadership

Founded by people who know the market.

SEVA was founded by two people with direct experience in the radiology disposables market, the OEM commercial model, and the global medical device supply chain. The company's positioning comes from that experience.

Denny Durmis

Co-Founder

Denny brings over 28 years of experience in global market development, commercial strategy, and leadership in the medical and healthcare sectors. He previously held SVP-level roles at Bayer Radiology, covering EMEA and the Americas, and at MEDRAD, where he also led the integration of MEDRAD into Bayer following its acquisition. He holds an MBA from Carnegie Mellon and a BS in Electrical Engineering from the University of Pittsburgh. He has served as an active Board Member with MITA, AdvaMed, and Life's Work of Western PA. That depth of experience in the radiology market informs how SEVA understands the needs of imaging departments and the administrators who run them.

Rakesh Amin

Co-Founder

Rakesh brings more than 25 years of experience across commercial strategy, service operations, program management, and finance in the medical imaging industry. He previously held senior roles at Bayer Radiology, including VP of Strategic Projects and Launch Excellence, Head of the R&D Program Management Office, Head of US Service, and Controller for Region Americas. He holds an MBA from Cornell University (SC Johnson) and a BS in Finance from Northeastern University. That blend of commercial, operational, and financial leadership in the medical imaging industry informs how SEVA serves the customers it works with.

Account Management

A dedicated account team, start to finish.

Every SEVA account is managed directly by a dedicated commercial team. No call center, no automated routing, no ticket queue. From first inquiry through sampling, VAC documentation, and ongoing supply, you work with the same people who know your facility and your platforms.

Market Context

A $500M market. With a clear opening.

Industry estimates put the U.S. contrast injector market in the ~$500–600M range, growing at roughly 7% per year. Roughly half of it is locked into proprietary, single-vendor platforms across the major OEMs — still under active OEM control. SEVA's currently addressable segment is an estimated ~$250 million, expanding as the current Bayer end-of-life wave pushes equipment off the forced-upgrade path and into SEVA's lane.

SEVA holds a position few non-OEM suppliers in the U.S. market hold: manufacturing pedigree shared with a major European medical device manufacturer, sold direct, into a market heading toward a once-in-a-decade end-of-life event between now and 2028. The website exists to make that position visible to the Radiology Administrators who are about to need it.

U.S. market sizing per third-party industry estimates (e.g., Grand View Research, 2024); SEVA's addressable segment and growth assumptions are internal estimates.

$500M+

U.S. contrast injector market — industry estimate, ~7% annual growth

$250M

Estimated segment currently addressable by SEVA across supported platforms

20+

Injector models supported across CT, MR, and angiography

Major EOL platforms SEVA continues to supply past the OEM cutoff