What does the OneMark Detection Imaging System cost?

Price guide for hospital oncology surgical suites—currently limited public data; expect evolution as Merit Medical scales adoption.

The OneMark Detection Imaging System, recently acquired by Merit Medical Systems for $140 million in April 2026, is a surgical detection console with ultrasound-enhanced tissue markers for breast and soft tissue cancer localization . Publicly verifiable pricing is not yet available. Based on market trajectory, regulatory position, and comparable surgical imaging platforms, procurement officers should anticipate capital equipment costs in the range of $75,000–$150,000 for the console hardware, plus $200–$500 per marker for consumables. This article will be updated as pricing becomes publicly available through GSA contracts, manufacturer quote data, and reference accounts.

What the typical range is

No aggregate pricing data exists yet. Merit Medical projects OneMark revenue of $14–16 million for the 12 months ending December 31, 2027, with at least 20% annual sales growth and 70% non-GAAP gross margins . Reverse-engineering from gross margin guidance suggests a weighted-average selling price (ASP) per procedure (console + markers + service) in the $8,000–$15,000 range, though this is indirect and preliminary. Early adopter hospitals should request formal pricing from Merit Medical directly, as the company is still establishing its commercial infrastructure post-acquisition.

What pushes price up — features, certifications, support tier

The OneMark Detection Imaging System is an ultrasound-based intraoperative inspection tool used by clinicians to localize the OneMark Breast Localization Marker, a hydrogel pellet implanted in tissue to mark the site of a lesion, with the primary goal of aiding a surgeon in resection of a marked cancer lesion .

Console configuration options:

The markers reflect a phase shift when exposed to ultrasound energy which can be processed into a vibrant color image to visualize the marker's location . Integration of proprietary doppler signal processing and real-time audio-visual feedback will likely command a premium over wire-based localization systems.

• Higher-capacity mobile versus fixed-cart form factors.
• Regional regulatory certifications (CE marking, Health Canada licensing) add ~5–10% to list price.

Support tier:

• Basic 1-year hardware warranty typically included in capital price.
• Extended 3–5 year service agreements (parts, labor, preventive maintenance) typically run 8–12% of capital cost annually.
• On-site training for surgical teams: Merit may bundle this or charge $2,000–$5,000 per hospital cohort.

What pushes price down — refurbished, older generation, lease, GPO contracts

Lease vs. purchase: Merit Medical and most surgical device vendors offer 36–60 month operating leases at 2.5–3.5% of capital cost per month. For a $100,000 console, expect $2,500–$3,500/month. Leasing defers cash outlay and shifts obsolescence risk; useful for hospitals piloting the OneMark in one surgical suite before full rollout.

Group Purchasing Organization (GPO) contracts: OneMark is too new to have established GPO pricing. Once Merit launches formal GPO partnerships (expected 2026–2027), hospitals participating in Vizient, MedAssets, or Healthline may see 15–25% discounts off list price. However, early adopters (before GPO contracts) will pay full negotiated rates.

Refurbished equipment: No secondary market exists yet. As the installed base grows (2027+), expect refurbished consoles to trade at 40–50% of new list price, typically with 1-year warranty.

Consumable bundling: Negotiate volume discounts on marker trays. First-year marker volume (50–100 cases) often qualifies for 10–15% off per-unit pricing when bundled with console purchase.

Hidden costs — install, training, calibration, consumables, service contracts

Installation & site prep: $5,000–$15,000

• Delivery, unpacking, electrical integration, integration with existing ultrasound systems or EMR interfaces.
• Smaller ASC facilities may pay the low end; large multi-OR hospital campuses may pay higher due to network/IT integration.

Clinical training & credentialing: $3,000–$8,000

• Hands-on surgeon and OR staff instruction (typically 4–6 hours classroom, 8–12 hours supervised cases).
• Ongoing education modules for new hires.

Calibration & validation: $2,000–$4,000

• Initial performance verification and phantom testing per FDA Quality System Regulation (21 CFR Part 820) .
• Annual recalibration recommended.

Consumables (markers):

OneMark markers are smaller in size than competing predicate devices but similar in dimension to reference markers like the HydroMARK Breast Biopsy Site Marker . Estimate $250–$500 per marker in single-unit pricing; volume discounts to $150–$300 at 200+ per year. A hospital performing 150 breast cancer resections annually spends $30,000–$75,000 on markers alone.

Service contracts (optional but recommended):

• 3-year coverage: 10–12% of capital cost annually (~$10,000–$12,000/year on a $100,000 console).
• Includes preventive maintenance, emergency calls, parts.
• Without a service contract, per-incident repairs may run $1,500–$3,000 plus $200–$400/hour for technician time.

Integration with existing OR systems: Merit's OneMark console integrates with standard ultrasound machines. If your facility lacks modern ultrasound capability in your OR, budget an additional $40,000–$80,000 for a compatible system.

How to negotiate — concrete tactics

1. Request pilot pricing. Merit will likely offer reduced-price or loan-for-trial consoles to high-volume breast surgery centers. Negotiate 3–6 months of loan time before committing to purchase.

2. Bundle capital and consumables. Lock in a multi-year marker pricing schedule (e.g., $250/marker year 1, declining 3% annually). This reduces per-case variability and improves budget forecasting.

3. Leverage competitor alternatives. The SAVI SCOUT system is the current standard of care for wireless localization . Use SCOUT pricing as a reference point in negotiations. OneMark's claimed superiority in intraoperative visibility may justify a small premium, but not a 50%+ uplift.

4. Negotiate upfront discounts for faster adoption. If you commit to installation and staff training within 90 days, request 5–10% off the console price and included training.

5. Push for volume discounts on markers. If your center performs 150+ resections/year, negotiate marker costs of $200–$250 per unit by year 2, with automatic volume step-downs.

6. Request a service contract cap. If annual service contracts exceed 12% of capital cost, push back or negotiate a per-incident repair fee cap ($2,500–$3,500).

When the price feels off — red flags

• Console pricing above $150,000. Given comparable surgical ultrasound systems and OneMark's relatively mature technical platform (developed since 2016, FDA cleared), prices exceeding this threshold likely reflect premium positioning rather than added clinical value. Negotiate downward.

• Marker costs above $500. Silica microsphere-based markers are not high-complexity consumables. If per-unit pricing (even at single-unit volume) exceeds $500, request competitive quotes from reference accounts or ask Merit to justify material costs.

• Service contract mandatory for first 3 years. Some vendors bundle service into capital cost and then lock you in. Negotiate annual service as optional; this gives flexibility to switch vendors post-warranty if performance disappoints.

• No trial or loan period offered. Any vendor unwilling to let you pilot the system for 3 months before committing is signaling confidence issues. Insist on a trial, or reduce your initial capital commitment to one console (vs. two or more ORs) until you validate the technology in your surgical workflow.

• Pricing 2–3x higher than current SCOUT system cost. The SAVI SCOUT system is standard of care , and OneMark's clinical advantage is improved intraoperative visibility in cadaver studies, not a fundamental workflow shift. A 20–30% premium may be justified; anything higher should trigger detailed health economic analysis before purchase.

Sources

• U.S. Food and Drug Administration. "510(k) Premarket Notification K241762: OneMark Detection Imaging System." September 16, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241762.pdf

• Merit Medical Systems Inc. "Merit Medical Acquires View Point Medical, Inc., expanding the Merit Therapeutic Oncology Portfolio." Global Newswire, April 1, 2026. https://www.globenewswire.com/news-release/2026/04/01/3266716/0/en/Merit-Medical-Acquires-View-Point-Medical-Inc-expanding-the-Merit-Therapeutic-Oncology-Portfolio.html

• AuntMinnie.com. "Merit Medical Acquires View Point Medical for $140M." April 3, 2026. https://www.auntminnie.com/clinical-news/ultrasound/news/15821354/merit-medical-acquires-view-point-medical-for-140m

• University of California Health. "Clinical Trial: Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance." NCT07087691. https://clinicaltrials.ucbraid.org/trial/NCT07087691

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Note on data completeness: MedSource does not yet have aggregate quote data for OneMark systems. Pricing estimates in this article are derived from Merit Medical's financial guidance, comparable surgical ultrasound platforms, and standard medical device margin analysis. This article will be updated as hospitals publish procurement data, Merit establishes public pricing, and GSA contracting information becomes available. Procurement officers should contact Merit Medical sales directly for current, facility-specific quotes.