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Praxis: The Online Publication of The McCarthy Institute

Legal Shorthand: The Signal Gap in Athlete-Facing Medical Technology

By Olivia Gallegos

  1. Introduction

Athlete-facing medical technology increasingly competes on credibility as much as engineering. For many consumers, “patented technology,” “FDA approved,” and “used by pros” are shorthand for one message: this works. Presented together, these signals can reinforce one another and suggest a level of proven benefit that exceeds what the legal and regulatory record establishes. That disconnect between market-facing signals and the narrower substantiation behind them is the signal gap. The Q-Collar and BetterGuard illustrate how that gap operates in practice.

II. Defining Terminology

    “Patented Technology”

    The term “patented technology” is best understood as an intellectual property status signal, not a performance certification. Under U.S. patent law, a granted patent provides a right to exclude others from using the claimed invention; it does not grant a government endorsement of safety or clinical effectiveness.[1] In other words, patents reflect what the United States Patent and Trademark Office (USPTO) determined was eligible for patent protection under the patentability standards, not whether the invention achieves a promised health outcome.[2]

    It is also common for products to be labeled with patent numbers or similar patent-forward language. While those markings have legal significance in patent enforcement, they often function as a consumer-facing credibility cue, especially when paired with phrases like “patent pending.”[3] “Patent pending” (or “patent applied for”) simply signals that an application has been filed; it does not mean a patent has been issued or that any clinical claims have been validated.[4]

    “FDA Approved”

    “FDA approved” is widely used as an umbrella phrase, but in medical device regulation it is not a single uniform status. In general, devices are “cleared” through the 510(k) process, while higher-risk devices are “approved” through Premarket Approval (PMA).[5] The FDA classifies devices into Class I, Class II, and Class III based on increasing levels of risk.[6] Depending on a device’s risk profile and classification, it may reach the market through different premarket pathways, each carrying different evidentiary expectations.[7]

    Many Class II, and some Class I, devices are marketed through the 510(k) pathway.[8] A 510(k) is a premarket submission in which the manufacturer seeks to show the device is substantially equivalent to a legally marketed predicate device.[9] When the FDA agrees, it issues an order finding substantial equivalence; that order is what “clears” the device for marketing.[10] Importantly, many (but not all) Class I devices are exempt from 510(k) requirements, and some Class II devices are also exempt.[11] Even where a device is 510(k)-exempt, the exemption is not absolute.[12] Exemptions are subject to limits, and certain Class I devices are not exempt when the device’s intended use is substantially important in preventing impairment of health or presents a potentially unreasonable risk of illness or injury.[13]

    By contrast, PMA is the FDA’s “most stringent” type of device marketing application and is used primarily for Class III devices.[14] Approval is contingent on the FDA’s determination that, based on the evidence submitted, the device is sufficiently safe and effective for its intended use.[15]

    A smaller category of devices may qualify for humanitarian use. In that setting, a device may be designated a Humanitarian Use Device and marketed through a Humanitarian Device Exemption, which operates as an exception from the standard effectiveness requirement for devices intended to benefit patients with diseases or conditions affecting a small population.[16]

    Finally, the De Novo pathway provides a route to classify certain novel devices that are low-to-moderate risk and lack an appropriate predicate.[17] A De Novo request may follow a “not substantially equivalent” determination, and may also be submitted directly when appropriate.[18]

    A separate source of confusion is that FDA language is sometimes used administratively to describe registration and listing. The FDA has emphasized that “FDA registered” or “FDA certified” claims can be misleading, and that registration and listing information does not, by itself, establish that a device is approved, cleared, or authorized.[19] This is one reason FDA terminology can be accurate in a narrow sense yet can still be misinterpreted by consumers as a claim of proven clinical benefit.[20]

    “Used by Pros”

    The term “used by pros” is not a regulatory classification and it does not describe an evidentiary basis for a product’s safety or effectiveness. Instead, it is an endorsement signal that can influence consumer inference about performance, particularly in athletic markets where professional adoption is treated as a proxy for credibility.[21]

    Endorsements are governed by truth-in-advertising principles enforced by the Federal Trade Commission (FTC). [22] The FTC’s Endorsement Guides state that endorsements must reflect the honest opinions, findings, experiences, or beliefs of the endorser, and cannot be used to convey a misleading impression that would be deceptive if made directly by the advertiser.[23] In sports, this matters because “used by pros” often reports more than use; it can communicate an implied performance claim to consumers that the product will prevent injury or protect them in play.

    Additionally, “pro” status can turn an endorsement into an implied claim of expertise. The Guides treat “expert endorsements” with special care, explaining that if an advertisement represents – directly or by implication – that an endorser is an expert with respect to the endorsement message, that endorsement should be supported by an actual exercise of the represented expertise as it relates to ordinary consumer use.[24] In athlete-facing medical technology, a professional athlete’s experience may speak to comfort, usability, and/or performance in play, while consumers may infer clinical or biomechanical validation that is not necessarily what the endorsement represents.[25]

    III. Q-Collar Case Study

      The Q-Collar is a clear example of the signal gap in athlete-facing medical technology because a formal regulatory status can carry a broader, consumer-level meaning than the FDA record supports – especially when it is paired with “science-backed” messaging and professional athlete endorsements. In 2021, the FDA granted the Q-Collar De Novo classification as a Class II device and created a new generic device type for an external device for internal jugular vein compression, intended to increase blood volume to the brain to reduce specific brain changes following impacts to the head.[26]

      What makes the Q-Collar unique is the degree to which the FDA supplied boundary language about what the device has not been shown to do. The De Novo decision summary states that the data does not demonstrate the device can prevent concussion or serious brain injury.[27] It also limits the strength of any inference about long-term outcomes by noting that deficits of long-term cognitive function and clinical outcomes were not evaluated, and cautions against treating certain imaging findings as validated predictors of future brain injury.[28] The limitations described by the FDA are the public record’s clearest rejection of the Q-Collar’s most natural consumer-level meaning: concussion prevention.

      The controversy surrounding the Q-Collar is best understood as a dispute over evidence of efficacy and transparency. A 2025 Washington Post investigation reported that FDA reviewers expressed doubts about whether the evidence demonstrated meaningful protection and raised concerns that neuroimaging endpoints used in key studies may not reflect clinically meaningful outcomes.[29] The Post also reported that the FDA agreed to authorize the device only after parent company Q30, added limiting language to the owner’s manual that the device does not prevent concussions and long-term cognitive claims had “not been demonstrated.”[30] However, that limiting language was not similarly prominent in promotional materials.[31] In parallel, a peer-reviewed British Medical Journal investigation called for an independent reevaluation of the Q-Collar’s FDA authorization.[32] The investigation pointed to inconclusive evidence of clinical validation and concerns of recycled data and potential research misconduct in studies claiming the Q-Collar offers clinical benefit.[33]

      In response to the investigations, Q30 defended both its evidence and its marketing practices, stating that “the word ‘concussion’ appears on our website only once and only to state that the Q-Collar cannot prevent one.”[34] However, that representation does not resolve the interpretive problem the device presents. A marketing strategy can avoid the term “concussion” while still communicating a concussion prevention message through substitute terminology such as “brain injury,” “head impacts,” and “sub-concussive impacts.”[35] The message becomes stronger when presented alongside FDA-status cues and efficacy framing.[36] Accordingly, the operative question is not whether the website contains an express concussion prevention claim, but whether the marketing invites consumers to infer the very proposition that the FDA explicitly declined to establish: that the Q-Collar prevents concussions.

      Q30 also maintains a virtual patent marking page listing multiple U.S. patents associated with the Q-Collar and describing the page as notice under 35 U.S.C. § 287(a), reflecting an IP ownership and enforcement posture that exists alongside, but does not substitute for, the device’s FDA authorization.[37]

      Endorsements add another layer to the signal gap because they supply credibility cues that often overwhelm technical limitations. On September 4, 2025, Q30 announced a partnership with NFL cornerback Sauce Gardner as an official Q-Collar ambassador.[38] In the announcement, the Q-Collar was framed by Gardner as brain protection equipment that sets him up for life after his football career ends.[39] Gardner’s endorsement does not provide clinical proof, but it is easy for consumers to treat his statements as validation. A 2025 STAT article argues that once a device carries federal authorization and professional adoption, anecdotes become a “self-reinforcing loophole” where injury does not falsify the product’s perceived value, and the absence of injury is treated as confirmation of success.[40] The article discussed Gardner specifically, noting that he suffered a concussion while wearing the device and explaining how proponents can interpret that outcome as further proof of the Q-Collar’s necessity – “imagine how much worse it could have been without it.”[41] Consistent with that dynamic, Q30’s blog post from the week Gardner entered concussion protocol focused on his performance metrics without addressing injury status.[42]

      Collectively, these features explain why the Q-Collar has become a focal point in the broader debate over what De Novo authorizations communicate outside FDA documents. The Q-Collar underscores a recurring problem of implied meaning and the resulting signal gap. De Novo authorization can be accompanied by clear limiting language, including express disclaimers, yet the market-facing presentation of authorization can still function as a proxy for demonstrated efficacy. In athlete-facing product markets, FDA-status terminology, scientific framing, and endorsement narratives operate cumulatively, and they are likely to be received as confirmation of protection despite the qualified nature of the underlying record. Accordingly, the Q-Collar illustrates how regulatory compliance and consumer-level inference can diverge.

      IV. BetterGuard Case Study  

        The BetterGuard provides a useful contrast to the Q-Collar because it shows how the signal gap can form even when a product sits in a low-risk device category without a De Novo-style public decision summary for consumers to read. Parent company Betterguards describes the BetterGuard as an ankle brace for athletic stabilization and represents that it is listed with the FDA as a Class I over-the-counter medical device.[43] In consumer terms, that combination can read as injury-prevention equipment intended to reduce ankle injuries during athletic play.

        The FDA context for a device like this is different from the De Novo pathway in a way that matters for consumer interpretation. The FDA’s product classification database identifies “joint, ankle, external brace” as a Class I medical device and designates the category as 510(k)-exempt.[44] The corresponding regulation classifies a limb orthosis as Class I and describes the category as exempt from premarket notification requirements, subject to stated limitations.[45] The practical point is not that Class I devices are unregulated. It is that this category does not typically generate a device-specific FDA authorization document that explains what evidence was reviewed for a particular branded brace or sets out boundary language about what the product has not been shown to do.[46] That difference matters because the Q-Collar controversy highlighted the mismatch between the FDA’s narrow record and how the product is received in the market. With the BetterGuard, consumers see the marketing and the FDA-related language without an accompanying narrative that performs a similar boundary-setting role.

        Betterguards also makes patents part of the product’s presentation more directly than Q30 does on its main purchase pages. Betterguards maintains a patent information page stating that the BetterGuard adaptive ankle support system is protected by patents and that additional patents are pending, and it frames the list as including protection for its ankle support brace and micro-hydraulic stabilizing technology.[47] However, the existence of patents does not answer the question consumers care about when the product is marketed as protection – does the device actually prevent injury?

        Endorsements and NBA-facing cues then reinforce the same message. In Betterguards’ U.S. launch messaging, the company publicly tied the product to brothers and NBA players Franz Wagner and Moritz “Moe” Wagner.[48] Betterguards also highlights its relationship to NBA Launchpad, and the NBA publicly identified BetterGuards as part of the inaugural cohort, describing its product as an adaptive ankle protection system aimed at preventing injuries while preserving freedom of motion.[49] Alone, none of these cues establishes clinical effectiveness. But when these cues appear together – FDA listing language, patent framing, and professional basketball validation – they can reinforce the same “this works” impression even without a controversial story like the Q-Collar.

        Taken together, the BetterGuard illustrates the signal gap in a lower-visibility setting. The Q-Collar produced a public record that expressly rejected the conclusion consumers most naturally draw. The BetterGuard sits in a category where consumers are less likely to encounter a device-specific FDA document that draws those lines in the first place. In that context, the consumer takeaway can still outpace what the underlying regulatory and intellectual property record supports. The doctrinal problem is not the accuracy of any single cue, but the net impression created by the combination of those cues.

        V. Discussion

        The signal gap is not simply a problem of literal falsity. Rather, it is a problem of consumer inference. Patent language, FDA language, and athlete endorsements each answer a narrower question when understood on their own. In athlete-facing marketing, however, consumers are unlikely to encounter or interpret those signals separately. They encounter them together, often in a single product page, social media post, endorsement campaign, or online marketplace listing. Thus, the legal significance of that bundle is not exhausted by the technical accuracy of each individual cue. The more important question is what message the overall presentation is likely to communicate to an ordinary consumer.

        Consumer Reality

        Generally, consumers do not approach athlete-facing medical technology with the background knowledge needed to parse patent law, FDA-related terminology, or endorsement doctrine with precision. Most ordinary buyers do not know what a patent actually signifies, and even fewer are likely to investigate whether “patented technology” refers to a granted patent, a pending application, or a feature only loosely related to the protective claim that caught their attention in the first place. The same is true of FDA-related terminology. A reasonable consumer is unlikely to distinguish between approval, clearance, authorization, registration, listing, exemption, and device classification in the way lawyers and regulators do. Instead, those terms often operate as shorthand for legitimacy and effectiveness, even though they do not all carry the same legal or evidentiary significance.

        Moreover, that interpretive problem has become more common because consumers increasingly encounter these products through social media and direct-to-consumer advertising rather than through clinical channels or detailed regulatory materials. In that setting, product information, endorsement, and persuasion often appear in the same visual and rhetorical format. A professional athlete’s post about a brace, collar, or recovery device may therefore be received less as paid or strategic advertising and more as practical guidance from a trusted figure. The environment encourages immediate inference, not tedious, technical research.

        That inference is especially foreseeable in sports because consumers often treat elite use as proof of product quality. If a consumer sees Sauce Gardner endorse the Q-Collar, the likely reaction is not to ask whether the endorsement independently establishes scientific substantiation. The more natural response is much simpler: if it works for an elite athlete, it will work for me. Use, sponsorship, preference, and proof are distinct concepts. Athlete-facing marketing, however, can collapse those distinctions by encouraging consumers to treat professional adoption as validation.

        Furthermore, patent and FDA language can make that inference stronger. When those cues appear alongside athlete endorsement, each adds a different layer of credibility. “Patented” may suggest innovation, technical sophistication, or superiority over competing products. FDA-related language may suggest government review or proof of safety and effectiveness. Endorsement supplies social proof and familiarity. Presented together, those cues can reinforce one another and create the impression that the product has been vetted in the way that matters most, even where the underlying record is narrower and more qualified. The signal gap operates in that space between legal meaning and consumer takeaway.

        The nature of athlete-facing medical technology itself makes the signal gap easier to overlook. These products are often noninvasive, familiar, and presented as part of ordinary athletic participation rather than as traditional medical interventions. Braces, helmets, padding systems, compression devices, massage guns, and recovery tools are sold in ordinary retail channels, used in everyday training and recovery, and integrated into athletic routines with little friction. That accessibility can make them feel less like products requiring careful scrutiny and more like practical solutions to an immediate problem. As a result, consumers may be less likely to ask whether the product’s perceived protective value is actually supported.

        Significance

        Consumer reality matters because these products are not sold in a neutral market. Rather, they are sold into a context shaped by fear of injury, desire for continued participation, and the search for reassurance. Parents and young athletes are a core example. Decisions about protective sports equipment are often made in the context of continued athletic participation, not withdrawal from the sport altogether. Parents may keep a child in a sport for many reasons, including the child’s love of playing, the social and developmental benefits of participation, and the possibility of future competitive opportunities, including scholarships. For many families, the practical question is not whether all risk can be eliminated, but whether risk can be reduced enough to justify continued play. A product marketed through patent status, FDA language, and athlete endorsement can appear to offer a responsible middle ground: making the sport safer to prevent abandonment.

        The same dynamic extends beyond youth sports. College athletes may have competitive, reputational, and increasing financial reasons to remain available for play, while professional athletes depend on continued participation for their livelihood. Those pressures help explain why injury-prevention marketing can be so effective across athlete-facing markets. The promise of added protection is most powerful where the costs of not playing are already high.

        Thus, consumers in that position are not merely purchasing equipment. They are often purchasing reassurance that continued participation remains responsible, manageable, and worth the risk. Patent status, FDA language, and athlete endorsement can converge into justification that the parent who allows continued play, or the athlete who returns before complete healing, is acting prudently rather than recklessly. Accordingly, the signal gap is more than a semantic concern. It is shaping a decision about whether and how to continue participating in activities with known physical risks.

        VI. Conclusion 

        Therefore, the signal gap presents not only an interpretive problem, but a regulatory one. Athlete-facing markets translate narrow legal categories into broad consumer meaning with particular force. Statements that are technically accurate do not eliminate the need for oversight when their legal meaning diverges from consumer understanding. That does not mean every athlete-facing product warrants regulatory intervention. Consumers routinely make imperfect purchasing decisions, and the law does not require every noninvasive or low-risk product to deliver substantial benefit. However, when a product’s advertising creates a misleading basis for reliance, the market cannot be expected to correct the signal gap on its own.

        Accordingly, the Federal Trade Commission is best positioned to address the signal gap. Patent law and medical device regulation remain important to the products and representations at issue, but they do not resolve the disconnect between legal categories and the consumer understanding those categories may generate in advertising. That responsibility instead falls to the FTC. Its authority over advertising, endorsements, and implied claims makes it the proper institution to confront a form of deception that the FDA and USPTO do not adequately reach. Applying the net-impression doctrine to the signal gap is therefore essential to evaluating the message consumers actually receive. Ultimately, without closer scrutiny, technically accurate cues will continue to operate as a substitute for proof in the minds of consumers.

        [1] U.S. Pat. & Trademark Off., Patents, https://www.uspto.gov/ip-policy/patent-policy/patents (last updated Nov. 7, 2025).

        [2] U.S. Pat. & Trademark Off., Managing a Patent, https://www.uspto.gov/patents/basics/manage (last updated Oct. 20, 2025).

        [3] Id.

        [4] Id.

        [5] U.S. Food & Drug Admin., Classify Your Medical Device, https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device (last updated Jan. 15, 2026).

        [6] Id.

        [7] U.S. Food & Drug Admin., Device Approvals and Clearances, https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-and-clearances (last updated Nov. 6, 2023).

        [8] U.S. Food & Drug Admin., 510(k) Clearances, https://www.fda.gov/medical-devices/device-approvals-and-clearances/510k-clearances (last updated May 29, 2024).

        [9] Id.

        [10] Id.

        [11] Id.

        [12] Id.

        [13] Id.

        [14] U.S. Food & Drug Admin., PMA Approvals, https://www.fda.gov/medical-devices/device-approvals-and-clearances/pma-approvals (last updated May 29, 2024).

        [15] Id.

        [16] Device Approvals and Clearances, supra note 7.

        [17] Id.

        [18] U.S. Food & Drug Admin., Evaluation of Automatic Class III Designation (De Novo) Summaries, https://www.fda.gov/about-fda/cdrh-transparency/evaluation-automatic-class-iii-designation-de-novo-summaries (last updated May 29, 2024).

        [19] U.S. Food & Drug Admin., Are There “FDA Registered” or “FDA Certified” Medical Devices? How Do I Know What Is FDA Approved?, https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved (last updated Mar. 3, 2021).

        [20] Id.

        [21] 16 C.F.R. pt. 255 (2025).

        [22] Id.

        [23] 16 C.F.R. § 255.1 (2025).

        [24] 16 C.F.R. § 255.3 (2025).

        [25] Id.

        [26] U.S. Food & Drug Admin, Device Classification Under Section 513(f)(2)(De Novo), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200017 (last updated Apr. 6, 2026).

        [27] Id.

        [28] Id.

        [29] Will Hobson & Daniel Gilbert, Device Claims to Protect Athletes’ Brains, but Records Reveal Doubts at FDA, Wash. Post (Oct. 16, 2025), https://www.washingtonpost.com/sports/2025/10/16/q-collar-football-concussions-fda/.

        [30] Id.

        [31] Id.

        [32] James M. Smoliga & Mu Yang, How an FDA Cleared “Brain Protection” Device Built on Shaky Science Made It to the NFL, 391 BMJ r2028 (Oct. 16, 2025), https://www.bmj.com/content/391/bmj.r2028.

        [33] Id.

        [34] Q30, In Response To Recent Criticism (Oct. 22, 2025), https://q30.com/blogs/blog/in-response-to-recent-criticism.

        [35] Q30, Science Behind Q-Collar, https://q30.com/pages/science (last visited Feb. 1, 2026).

        [36] Id.

        [37] Q30, Virtual Patent Marking, https://q30.com/pages/virtual-patent-marking (last visited Feb. 1, 2026).

        [38] Q30, NFL Star Sauce Gardner on Legacy, Motivation & the Q-Collar, (Sep. 4, 2025), https://q30.com/blogs/blog/how-new-york-jets-cornerback-sauce-gardner-is-protecting-his-longevity-on-and-off-the-field.

        [39] Id.

        [40] James Smoliga, A Sports Device to “Protect the Brain” Illustrates a Major Problem with the FDA De Novo Pathway, STAT (Nov. 2, 2025), https://www.statnews.com/2025/11/02/q-collar-fda-authorization-science-foia/.

        [41] Id.

        [42] Q30, Q-Collar Week in Review (10/20/25) (Oct. 20, 2025), https://q30.com/blogs/blog/q-collar-week-in-review-10-20-25.

        [43] Betterguards, The BetterGuard Ankle Brace, https://betterguards.com/products/the-betterguard-ankle-brace (last visited Feb. 10, 2026).

        [44] U.S. Food & Drug Admin., Product Classification, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm (last updated Apr. 6, 2026).

        [45] 21 C.F.R. § 890.3475 (2025).

        [46] Id.

        [47] Betterguards, Patent Information, https://betterguards.de/en-gb/pages/patents (last visited Feb. 12, 2026).

        [48] Betterguards, Betterguards Wins Sports Technology Award for Best Injury Prevention and Recovery Technology; Launches Ankle Brace Sales in U.S. Market (June 1, 2023), https://betterguards.com/blogs/the-betterguards-insights/betterguards-wins-sports-technology-award-for-best-injury-prevention-and-recovery-technology-launches-ankle-brace-sales-in-the-u-s-market.

        [49] NBA Communications, NBA Launchpad Selects Five Companies to Develop Future of Basketball-Related Technology (Jan. 6, 2022), https://pr.nba.com/nba-launchpad-selects-five-companies-to-develop-future-of-basketball-related-technology/.