OneMark™ breast localisation: integrating diagnosis and surgical guidance—a narrative review

Introduction

The evolution of wire-free breast localisation

Accurate localisation of non-palpable breast lesions is a critical determinant of successful breast-conserving surgery. Traditional wire-guided localisation, while effective, is associated with well-recognised limitations including patient discomfort, scheduling inflexibility, wire migration, and same-day dependency on radiology services. These shortcomings have driven the development and widespread adoption of wire-free localisation technologies.

Several wire-free platforms are now well established in clinical practice to localise non-palpable breast lesions and axillary lymph nodes requiring accurate surgical removal. Radar-based systems such as SAVI SCOUT^® (Merit Medical, Aliso Viejo, CA, USA) have demonstrated high localisation success and favourable pooled outcomes in both breast and targeted axillary surgery (1,2). Magnetic seed technologies such as Magseed^® (Hologic, Marlborough, MA, USA) have also shown reliable intraoperative detection and acceptable oncological outcomes (3). Radiofrequency identification (RFID) tags such as LOCalizer™ (Hologic, Marlborough, MA, USA) have likewise been reported to perform well in clinical practice (4). Radioactive iodine-125 seeds remain effective, although the regulatory and radiation safety requirements associated with their use have limited wider adoption (5). In addition, radioactive occult lesion localisation techniques, including radio-guided occult lesion localisation (ROLL)/sentinel node and occult lesion localisation (SNOLL), are established low-cost alternatives with documented efficacy and should be acknowledged in the broader localisation landscape (6). Wire-free techniques, specifically SAVI SCOUT, ROLL, and radioactive seed localization (RSL), have been reported to provide statistically significant reductions in re-excision rates and positive margin rates compared to wire-guided localisation (1,6).

Collectively, these technologies have improved patient experience and surgical workflow while maintaining high localisation accuracy. Comparative literature has also confirmed the advantages of non-wire approaches over traditional wire-guided localisation in several practical domains (5,6), although cost and logistical considerations remain important determinants of adoption. Srour et al. demonstrated that wire-free localisation devices, namely Savi Scout and RSL, were associated with reduced overall perioperative time compared to wire localisation (WL), with few complications (5).

However, despite their technical maturity, these platforms share a common structural limitation: they do not fundamentally alter the diagnostic-to-surgical pathway. In most cases, patients still undergo diagnostic biopsy with clip placement, followed by a separate localisation procedure prior to surgery. Thus, while wire-free technologies have replaced wires, they have largely preserved a two-step care pathway.

Importantly, this limitation must be interpreted in the context of the clinical distribution of biopsy outcomes. A substantial proportion of breast lesions undergoing core biopsy are ultimately classified as benign or probably benign and do not require further intervention. Therefore, a one-step localisation strategy cannot be assumed to be inherently advantageous in all patients, because routine deployment of a localisation-capable marker at biopsy may introduce additional cost in patients who never require surgery. This efficiency paradox is central to any balanced appraisal of OneMark™ (View Point Medical, Inc., Carlsbad, CA, USA) (7).

OneMark™ (7-10) proposes a new concept—not by offering superior signal strength or detection depth, but by collapsing diagnosis and localisation into a single procedural event with real-time intraoperative visualisation of the target. This narrative review examines whether such pathway efficiency represents a genuine clinical advance or an unproven conceptual ambition. We present this article in accordance with the Narrative Review reporting checklist (available at https://tbcr.amegroups.com/article/view/10.21037/tbcr-2026-1-0009/rc).

Methods

This article is a narrative review and critical appraisal of the OneMark™ breast localisation system. The literature search was conducted in June 2026 using PubMed and publicly available online sources (Table 1). Additional data were obtained from the U.S. Food and Drug Administration (FDA) 510(k) clearance documentation, the manufacturer’s technical material, and ClinicalTrials.gov. English-language publications relevant to breast localisation technologies, pathway design, cost implications, safety considerations, and evaluation of surgical innovation were considered. Because no peer-reviewed clinical outcome studies of OneMark™ were identified, the review also incorporated publicly available regulatory and technical documents, a recently published cadaveric study, and hands-on ex vivo device evaluation by the senior author.

The persistent pathway inefficiency

The standard pathway for managing non-palpable breast lesions remains inefficient, as it typically requires a sequence of separate steps that include an initial image-guided biopsy with clip placement, followed by histopathological diagnosis, then, for lesions requiring surgical excision, a distinct pre-operative localisation procedure, and finally definitive surgery. This can result in multiple visits, duplicated imaging, increased patient anxiety, and avoidable delays to treatment.

It should be noted, however, that only a minority of lesions undergoing biopsy subsequently require further intervention. Indeterminate lesions such as B3 or B4 account for a relatively small proportion of biopsies (11-13). In the national breast screening program in England, the rate of B3 and B4 lesions was recorded to be 7.9% (53% with atypia) and 0.6%, respectively (13). Moreover, many biopsied lesions are ultimately benign and therefore never require open surgical excision (11,12). This is important because any pathway claiming greater efficiency through routine marker deployment at biopsy must be weighed against the fact that many patients will never need subsequent localisation.

Nevertheless, for the subgroup of patients who do require surgery, the current sequence introduces duplication of invasive procedures, increased use of radiology resources, and additional hospital visits. Even with wire-free systems, localisation is usually performed as a discrete episode shortly before surgery, requiring coordination between radiology and surgical services.

From a systems perspective, this remains a significant inefficiency—particularly in high-volume centres or healthcare systems under increasing pressure to streamline care delivery. OneMark™ explicitly targets this inefficiency by redefining localisation as an extension of diagnosis rather than a pre-operative adjunct.

The OneMark^TM technology

The OneMark™ system (View Point Medical, Inc., Carlsbad, CA, USA) consists of a hydrogel-based marker measuring approximately 3 mm × 5 mm when hydrated. The marker incorporates a metallic clip and Doppler-visible silica (silicon dioxide) microspheres embedded within a gelatin-based hydrogel pellet deployed through a 17-gauge needle at the time of diagnostic biopsy (7,8,10).

Unlike conventional biopsy clips, the marker is designed to serve a dual function: permanent diagnostic marking and subsequent intraoperative localisation. In theatre, localisation is achieved using a handheld probe connected to a console that detects the Doppler signal generated by the embedded microparticles. Figure 1 illustrates the OneMark™ system, including the marker, delivery system, probe and console.

Figure 1 The OneMark localisation system comprising a console with handheld probe, percutaneous delivery device, and OneMark clip. Reproduced from Zheng et al. (7) under a Creative Commons Attribution 4.0 International licence (CC BY 4.0).

The system provides three complementary forms of feedback to support accurate localisation: visual confirmation of the marker position on the display, millimetric measurement of the distance between the probe and the marker to allow precise spatial orientation, and an audible cadence that varies with proximity, giving the operator real-time acoustic guidance as the probe approaches the marker (8,10). Figure 2 illustrates a representative ultrasound image demonstrating OneMark™ marker detection at a depth of approximately 20 mm with real-time visual localisation of the marker within breast tissue.

Figure 2 Representative ultrasound image demonstrating OneMark™ marker detection at a depth of approximately 20 mm. The marker is visualised as a high-signal focus with overlaid targeting crosshairs, with the vertical and horizontal guides indicating probe alignment and millimetric depth measurement, illustrating real-time visual localisation of the marker within breast tissue.

Importantly, the system is designed for surgeons’ use without requiring formal ultrasound interpretation skills, shifting localisation from image-based assessment to signal-based detection with visual confirmation (7). However, this should not be interpreted as eliminating operator dependency. In practice, surgeons must still integrate Doppler-based visual and auditory feedback in real time, and the learning curve for this process remains undefined.

Moreover, the technical specifications of the system, including maximum detection depth, remain unpublished in publicly available documents (7). This information will be critical for evaluating suitability across diverse anatomical scenarios, particularly for deep-seated lesions, patients with larger breast volumes, or technically challenging operative environments. Detection was demonstrated in an image at approximately 20 mm depth (Figure 2) and in an ex vivo test at 36 mm depth, but the maximum detection depth remains unknown and unpublished (7).

The senior authors (K.M. and A.M.) undertook an informal ex vivo familiarisation assessment of the OneMark™ system using an ex vivo breast tissue model in which the marker had been previously deployed using a 17-gauge needle at 36 mm depth. The assessment focused on intraoperative detection performance and practical handling characteristics. The handheld Doppler probe provided clear visual confirmation of marker location with colour-enhanced imaging on the console display, and distance measurement accuracy appeared reliable within the tested range. The auditory cadence provided intuitive proximity feedback without requiring direct screen visualisation.

The system appeared straightforward to use during ex vivo assessment, suggesting a potentially shallow learning curve for surgeons familiar with handheld ultrasound probes, although this observation requires validation in clinical practice. This was also observed in the recently published cadaveric study (7). While these preliminary observations support technical feasibility, they do not substitute for clinical validation in live patients across diverse anatomical scenarios, tissue densities, and operative conditions.

A further practical unknown is whether local factors such as post-biopsy haematoma, fibrosis, or tissue compression may affect detectability, as has been reported with some other localisation approaches. Likewise, whether marker size could interfere with subsequent vacuum-assisted excision (VAE), if required, remains uncertain. These issues merit prospective study before broad clinical adoption.

Pathway efficiency as the primary advantage

The defining feature of OneMark™ is not its detection mechanism but its pathway integration. By enabling marker placement at the time of biopsy and reliable detection months later, the system eliminates the need for a separate pre-operative localisation procedure.

This streamlined pathway confers several important potential efficiency gains, including a reduction in radiology workload and scheduling complexity, elimination of the constraints associated with same-day localisation, fewer hospital visits for patients, and shortening of the overall diagnostic-to-surgical timeline.

Crucially, the marker could be theoretically deployed in most breast lesions requiring biopsy, under any imaging guidance, and subsequently localised using Doppler detection with both audio and visual feedback. This universality distinguishes OneMark™ from other wire-free systems, which are typically reserved for lesions already confirmed as malignant or strongly suspected to require surgery.

At the same time, the potential efficiency gain must be balanced against the risk of overuse. Because a substantial proportion of biopsied lesions prove benign (11,12), routine deployment of a localisation-capable marker at biopsy could create a new form of systemic waste unless the device is priced sufficiently close to, or below, standard marker clips. The clinical argument for pathway integration is therefore inseparable from the economic argument.

Although the malignancy rate among lesions undergoing image-guided biopsy is substantially higher than the positive predictive value reported for screening ultrasound examinations, a considerable proportion of biopsied lesions ultimately prove benign and do not require subsequent surgical intervention. Consequently, routine deployment of a localisation-capable marker at biopsy may result in unnecessary costs in many patients.

A further pathway issue is what happens if the marker cannot be detected or has migrated. OneMark™ does not eliminate the need for a contingency pathway. In such cases, a rescue localisation procedure using a conventional technique would still be required. This is especially relevant in settings where reliable same-day access to radiology remains necessary as a backup.

Operator dependency and learning curve

A critical unknown is the extent to which OneMark™ detection performance is operator-dependent and the associated learning curve for surgical teams. Unlike wire-guided localisation, which relies on direct visualisation and palpation, or radar-based systems such as SAVI SCOUT^®, which provide numerical distance readouts with relatively limited interpretive demands (1,2), OneMark™ requires the surgeon to integrate visual Doppler imaging with auditory feedback to localise the marker (7-10).

Using a cadaveric breast model, Zheng et al. (7) demonstrated that the Doppler-guided OneMark™ localisation system achieved detection times comparable to those of conventional ultrasound-visible clips, with the gelatin-encased marker demonstrating the shortest mean detection time of all targets (31 seconds). OneMark™ also received significantly higher visibility ratings and generated greater operator confidence, particularly for deeper lesions, suggesting that its audiovisual feedback system may facilitate localisation and potentially shorten the learning curve associated with ultrasound-guided breast surgery.

However, while the manufacturer suggests that formal ultrasound interpretation skills are not required, the cognitive and technical demands of real-time Doppler-guided localisation in the operative setting remain largely uncharacterised. Key questions include how many cases are required to achieve competency, whether performance varies according to baseline ultrasound experience, and whether failure-to-detect rates decline with increasing operator experience.

These questions are particularly relevant given that the system is intended for routine use across diverse surgical teams with varying levels of exposure to intraoperative ultrasound. Prospective clinical evaluation should therefore incorporate operator-level performance metrics, stratified by case volume, to determine whether OneMark™ can consistently deliver reliable outcomes independent of individual surgeon experience.

Clinical scenarios of particular interest

Neoadjuvant systemic therapy

OneMark™ remains detectable for several months after deployment, making it potentially suitable for patients undergoing neoadjuvant systemic therapy. The reported minimal MRI artefact (<2 mm) supports compatibility with interval imaging, which is a key requirement in this setting (8,10). This is clinically relevant because neoadjuvant chemotherapy is particularly beneficial in biologically aggressive subtypes, which are also more likely to achieve a pathological complete response and therefore require accurate pre-treatment target marking for subsequent surgery.

By comparison, the SAVI SCOUT^® reflector—currently regarded as one of the most MRI-compatible active localisation devices—produces an MRI signal void of approximately 4.5 mm (1), which is substantially smaller than the artefact associated with Magseed^® (3) and RFID tags (4). However, the MRI artefact data for OneMark™ are currently manufacturer-derived rather than independently validated, and there are no peer-reviewed clinical data confirming long-term signal stability or positional consistency throughout a full course of neoadjuvant therapy.

A related issue is marker displacement. For any lesion localisation device, displacement risk is highly relevant, particularly when surgery occurs after a prolonged interval or after major treatment response. The advantage of some established devices is their perceived stability; by contrast, there are as yet no human data on displacement rates for OneMark™. This is an important issue to address before routine use in neoadjuvant settings.

Axillary and nodal applications

The small marker size makes OneMark™ (7) attractive for deployment in pathological lymph nodes, potentially supporting targeted axillary dissection strategies. However, this application remains theoretical and requires prospective validation. It is not yet known whether the Doppler signal can be detected as reliably in the more complex anatomy of the axilla as in the breast, or whether significant nodal regression after systemic therapy might affect detectability.

Multifocal and extensive disease

The technology may also be useful for bracketing multifocal or extensive disease. While conceptually appealing, the feasibility and reliability of multi-marker detection using Doppler-based localisation have yet to be established. In particular, potential crosstalk or interference between multiple signals has not been studied. Whether individual markers can be reliably distinguished when deployed in close proximity remains unknown.

SCOUT MD™ has been recently introduced to address recognised technical limitations of single-reflector radar localisation (RL) systems, particularly in multi-target localisation and tight bracketing scenarios (14).

Comparison with established wire-free technologies

A critical distinction between OneMark™ and existing wire-free platforms lies in strategic intent. Technologies such as SAVI SCOUT^®, Magseed^®, RFID tags, and radioactive iodine seeds are mature, versatile, and supported by extensive clinical evidence (1-5). They offer robust signal detection, proven performance in axillary surgery, and reliable function in complex operative environments.

ROLL/SNOLL techniques also deserve mention as effective and comparatively inexpensive localisation options with an established literature base. Although they were not the focus of the original discussion, they provide an important benchmark when considering the claim that OneMark™ may be especially relevant in lower-resource settings.

Established hydrogel biopsy markers, including HydroMARK^®, are already capable of facilitating ultrasound-guided localisation in selected patients and therefore provide an important comparator when evaluating the potential clinical role of OneMark™. While hydrogel markers may become less conspicuous over time as the hydrogel component resorbs, substantial clinical experience exists regarding their behaviour during neoadjuvant therapy. In contrast, the long-term performance characteristics of OneMark™, including signal stability, detectability after treatment response, and positional consistency over several months, remain largely uncharacterised. Whether the Doppler-based detection mechanism offers a meaningful clinical advantage over existing ultrasound-visible hydrogel markers therefore remains uncertain and should be considered an important objective of future comparative studies.

By contrast, OneMark™ prioritises pathway simplification over maximal technical versatility. This distinction suggests that these approaches may ultimately prove complementary rather than mutually exclusive, with OneMark™ best suited to straightforward cases where efficiency and cost are paramount.

In practice, centres may ultimately deploy OneMark™ for straightforward breast-conserving surgery while reserving established technologies for complex cases such as deep-seated lesions, patients with larger breast volumes, or anatomically challenging scenarios where maximum detection depth is critical. Table 2 summarises the comparative features of OneMark™ and other widely used wire-free localisation technologies.

Preclinical and simulation evidence

A cadaver-based training study by Zheng et al. (7) evaluated the OneMark clip and console (View Point Medical), a novel Doppler-guided localisation system employing gas-filled silica shells that generate a characteristic audiovisual signal, against standard ultrasound-visible biopsy clips and olive phantoms in eleven surgical trainees. Detection times were comparable across all target types (range 31–44 seconds), with no statistically significant differences between clip types; however, posterior lesions required significantly longer identification times than anterior lesions (adjusted mean difference 27.9 seconds, P=0.004). Notably, the OneMark clip received significantly higher visibility ratings than the standard biopsy clip (P=0.0001), with near-universal ratings of definite visibility, particularly at posterior depths where standard clips performed poorly. Trainees unanimously valued the audible Doppler feedback as an adjunct to standard B-mode imaging, reporting enhanced confidence especially in challenging anatomical locations. The authors acknowledge key limitations, including the small sample, absence of perfused vasculature, non-randomised lesion identification order, and industry sponsorship, and call for prospective clinical validation using margin status and re-excision rate as endpoints.

It should be noted that this cadaveric study was supported by View Point Medical, the device manufacturer, which is consistent with the broader industry-sponsorship considerations discussed elsewhere in this review.

Evidence gap and imminent clinical evaluation

At present, there are no published peer-reviewed clinical outcome data for OneMark™. All available information is derived from FDA clearance documentation and manufacturer-provided technical descriptions (8,10). The FDA clearance was granted in 2024 based on Good Laboratory Practice (GLP)-compliant animal studies and non-clinical performance bench testing, without requiring human clinical data (8). However, FDA clearance does not constitute evidence of clinical superiority or clinical effectiveness.

Importantly, a prospective clinical trial has commenced recruitment (9), representing a critical step toward defining localisation reliability, workflow impact, and oncological outcomes. The most clinically relevant primary endpoints for future studies will be successful localisation, margin positivity, and re-excision rates. Until such data are available, OneMark™ should be regarded as an innovative but evaluative technology.

Much of the currently available technical information is manufacturer-provided, which carries an inherent risk of industry bias. This concern is not merely theoretical. Sponsorship of medical device evaluation studies by manufacturing companies has been associated with more favourable efficacy results and conclusions than sponsorship from other sources, and there may be an industry bias not fully captured by standard risk-of-bias assessments. For that reason, an independently conducted evaluation will be especially important in defining the true performance of this device.

Cost and global relevance

Preliminary information suggests that OneMark™ is significantly less expensive than other wire-free localisation technologies. If confirmed, this cost advantage could make it particularly relevant to healthcare systems with constrained resources, where access to established localisation platforms is limited.

However, this claim remains theoretical unless considered in the context of both capital and pathway costs. Even if the individual marker is inexpensive, the system still requires a dedicated console and probe, which may represent a meaningful barrier to entry for some providers. Cost-effectiveness must therefore consider not only per-case consumable cost but also system acquisition and implementation costs.

When considering the cost-effectiveness of OneMark™, it is important to recognise that the vast majority of breast core biopsies do not proceed to further intervention. In large clinical series, approximately 60% of lesions undergoing biopsy are ultimately classified as benign or probably benign (B1–2) and therefore do not require open surgical excision or vacuum-assisted biopsy (11,12). Approximately 1.6 million breast biopsies are performed annually in the United States, the majority being image-guided percutaneous core needle biopsies (15) (Appendix 1). Consequently, if a OneMark™ device were to be deployed universally at the time of biopsy, its economic impact should be considered in relation to the current diagnostic pathway.

Under standard practice, a conventional hydrogel marker clip is placed at biopsy, while only patients proceeding to surgical excision subsequently undergo a localisation procedure, most commonly using the SAVI SCOUT^® system at our institution. Notably, some centres already deploy SAVI SCOUT^® at the time of biopsy for lesions that are radiologically highly suspicious and highly likely to require surgery.

In modern clinical practice, a delayed secondary localisation procedure is required in only a small proportion of patients. Approximately 70% of B3 lesions undergo VAE (16), of which around 20% are subsequently upgraded to malignancy, while the remainder avoid surgery. Consequently, beyond patients with confirmed malignancy, only a limited additional proportion of biopsy patients ultimately require operative excision. Under a pathway in which malignant lesions are localised at the time of biopsy, delayed localisation would be expected to involve only a small minority of all biopsy patients.

The economic benefit from avoiding this secondary localisation must therefore be balanced against the universal deployment of a localisation-capable marker that is more expensive than a standard marker clip in the large proportion of patients whose biopsy proves benign. These considerations should be taken into account when determining the commercial pricing of the OneMark™ device, as the limited proportion of patients requiring delayed localisation constrains the potential economic benefit of universal deployment.

Based on a simplified pathway model using the assumptions outlined above, we estimate that the commercial price of OneMark™ marker would likely need to be below approximately 57% of the price of SAVI SCOUT^® reflector to achieve comparable pathway-level cost-effectiveness, assuming non-inferior clinical performance. This estimate should be regarded as illustrative rather than definitive, as it is derived from a simplified economic model that incorporates several assumptions regarding biopsy volumes, rates of subsequent intervention, device utilisation, and clinical performance (Appendix 1). Nevertheless, it highlights the relatively small proportion of biopsy patients who ultimately require delayed localisation and underscores the importance of pricing strategy and patient selection in determining the economic value of the technology. In our calculations, we used a conservative estimate of 1.36 million image-guided core biopsies performed annually in the United States (15); however, the true number is likely higher, reflecting increasing utilisation associated with more intensive imaging and screening. Consequently, this break-even threshold of approximately 57% would be expected to fall further as the number of core biopsies increases. This analysis also assumes non-inferior clinical performance of OneMark™ compared with SAVI SCOUT^® and a simplified pathway model.

These considerations suggest that selective deployment—for example, in lesions highly suspicious for malignancy or otherwise likely to proceed to surgery—may prove more cost-effective than universal use in all biopsied lesions.

In addition to consumable costs, the capital expenditure associated with the acquisition of the localisation system must also be considered when evaluating overall cost-effectiveness. For example, Nguyen et al. demonstrated that RL was more cost-effective than WL, despite the higher upfront cost of the technology (17). Their analysis suggested that approximately 300 RL procedures would need to be performed to offset the capital cost of the localisation system and achieve cost neutrality. These findings highlight the importance of considering both procedural and equipment-related costs when assessing the economic viability of new localisation technologies such as OneMark™.

Long-term safety

While the USP-grade porcine gelatin-based hydrogel carrier is designed to resorb, the microspheres themselves are not stated to be bioresorbable in publicly available regulatory summaries (7,8). Silicon dioxide is widely used as an excipient in oral medications and is considered safe for ingestion; however, this regulatory experience relates to short-term gastrointestinal exposure rather than long-term implantation. There is little historical precedent for the deliberate long-term placement of free silica microspheres within human soft tissue, and therefore the safety of this specific application is supported primarily by International Organization for Standardization (ISO) 10993 biocompatibility testing and GLP animal implantation studies, with limited published long-term human outcome data to date (7,8).

This issue becomes especially important if OneMark™ were to be used routinely at biopsy, because many patients with benign lesions would continue to have the device in situ long-term. The absence of human implantation data, therefore, represents a genuine evidence gap rather than a theoretical concern.

Ethical and cultural considerations related to porcine gelatin use

The OneMark™ carrier is derived from porcine gelatin, which may raise cultural and religious sensitivities for some patients, particularly those from Muslim and Jewish faith backgrounds, in addition to vegetarians and vegans. This is an important consent consideration, as the acceptability of porcine-derived implantable materials varies, and transparent disclosure is necessary to allow informed patient choice and to support culturally sensitive shared decision-making.

This factor may also influence the claimed global relevance of the device, because acceptability cannot be assumed across all healthcare settings and patient populations.

Pragmatic implementation through structured audit

Given FDA clearance and the fact that OneMark™ does not alter the underlying surgical treatment—breast-conserving surgery with oncologically appropriate margins—a pragmatic implementation pathway merits consideration. Rather than awaiting completion of large prospective trials, early-adopting centres could introduce OneMark™ through a prospective clinical audit framework. A sample size of approximately 100 consecutive cases would provide reasonable early information on technical performance compared with the centre’s established localisation method.

The audit should prospectively capture key metrics including successful localisation rate and margin positivity as primary outcomes, with operative time, re-excision rate, technical failures, patient experience, and pathway intervals from biopsy to surgery included as secondary endpoints. Governance safeguards are essential and should include ethics or institutional review approval where required, explicit informed consent documenting the evaluative nature of the technology, availability of WL or another standard technique as a rescue procedure, and commitment to transparent reporting of outcomes.

Because no peer-reviewed clinical outcome data currently exist, this early evaluation should be investigator-initiated and conducted independently of manufacturer sponsorship or data oversight. Independent assessment minimises sponsorship bias and ensures credibility of safety and performance outcomes, consistent with established principles for the evaluation of surgical innovations and medical devices (18). Sponsorship of medical device evaluation studies by the manufacturing company leads to more favourable efficacy results and conclusions than sponsorship by other sources, and there may be an industry bias that cannot be fully explained by standard risk-of-bias assessments (19).

While manufacturer registries may provide useful post-market surveillance data, the primary evidence base defining localisation success, margin status, re-excision rates, and workflow impact should arise from academically led studies in which investigators retain full control over study design, analysis, and publication.

If audit data demonstrate non-inferior performance compared with established technologies, centres could then adopt OneMark™ more routinely. Conversely, if early audit identifies an unacceptable technical failure rate, higher margin positivity, or major operator learning-curve effects, implementation should be paused or restricted pending further refinement. This approach accelerates real-world evidence generation while maintaining robust patient safeguards and may be particularly valuable in healthcare systems seeking cost-effective alternatives to established wire-free platforms.

Conclusions

OneMark™ represents a novel attempt to re-engineer breast localisation by integrating diagnosis and surgical guidance into a single step. Its principal innovation lies in pathway efficiency rather than incremental improvements in localisation technology. While its theoretical advantages are compelling, its ultimate role will depend on prospective clinical validation.

If forthcoming trials demonstrate reliable performance and oncological equivalence, OneMark™ has the potential to offer a complementary approach and, in some clinical scenarios, may prove preferable to existing technologies. Until then, its adoption should remain selective and evidence-driven.

A practical early use strategy may be selective deployment in lesions that are highly suspicious for malignancy or otherwise likely to require surgery, rather than universal use at biopsy. That approach may better align the theoretical pathway advantage with real-world cost-effectiveness.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the Narrative Review reporting checklist. Available at https://tbcr.amegroups.com/article/view/10.21037/tbcr-2026-1-0009/rc

Peer Review File: Available at https://tbcr.amegroups.com/article/view/10.21037/tbcr-2026-1-0009/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tbcr.amegroups.com/article/view/10.21037/tbcr-2026-1-0009/coif). K.M. serves as an unpaid editorial board member of Translational Breast Cancer Research from May 2025 to June 2027. A.M. and K.M. have received honoraria from Merit Medical, the manufacturer of the SAVI SCOUT^® breast localisation system, for advisory services. OneMark™ is manufactured by ViewPoint Medical. The authors have not received honoraria, consultancy fees, research funding, or other remuneration from ViewPoint Medical, and have no financial interest in that company. The other author has no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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