I had some time on my hands and an axe to grind after learning that Shunyata claims to make medical power conditioners, so after weeks of digging, voila!
Why Bother With Shunyata Research’s Medical Claims?
Many people here already roll their eyes at Shunyata Research’s claims, and justifiably so, given the absence of any technical transparency from the company. It’s easy to ignore them as just another audiophile brand selling smoke, mirrors, and unicorn tears.
But this is different. Shunyata isn’t just targeting audiophiles, they’ve set up a so-called medical device company and now claim their noise reduction technology is making hospitals and heart procedures safer. Thus, their audiophile business gets the added boost of being “endorsed” by doctors and hospitals across the United States.
You might wonder: Why bother digging deeper when the marketing is obviously suspect? It’s easy to assume Shunyata just set up a fake medical company to bolster their audiophile business.
That could well be true, but to my knowledge, no one has ever done a full deep dive into these claims. That changes today. If you were suspicious before but didn’t have time to look into this, this writeup provides the facts you need. If you’ve already done some digging, this adds more detail. And if you’ve seen enough to dismiss their claims, this can be your reference for the future—no need to hunt down the facts again.
Whether you’re a skeptic, on the fence, or just curious, my goal is to present the facts. This isn’t just about debunking more audio nonsense; it’s about exposing claims that cross the line from silly to genuinely dangerous.
If you want the short answer: the evidence so far says these medical device claims don’t hold up. For the details, read on.
The Claims
Shunyata Research, along with its medical device affiliate Clear Image Scientific, makes the following claims:
Claim 1: Shunyata makes power conditioners and power cables for cardiac electrophysiology labs.
This claim is highly questionable. For a supposedly legitimate company, the website created for Clear Image Scientific (CIS) is extremely barebones. The “About Us” page contains almost no information; the “Designer Background” page is copied directly from Shunyata’s audio website. “Technology” and “Products” pages recycle generic marketing language from their consumer audio business, without sufficient technical documentation or clinical data [3]. The “Case Studies” are vague [4], and the only contact for the entire company is Shunyata’s own sales director.
Genuine medical device manufacturers will provide regulatory information (FDA/CE/ISO), technical specifications, product documentation, clinical data, support resources, purchasing channels, and legal disclosures. The CIS website lacks virtually all of these, suggesting it serves as a placeholder to prop up Shunyata’s legitimacy in the audio industry, rather than a functioning medical device company.
In the same vein, if Shunyata/CIS were a legitimate medical device manufacturer, their products would likely be available through independent medical suppliers and distributors. However, a Google search for their “CIS Model-6” returns only Shunyata or CIS pages. Searches on major U.S. medical distributors such as McKesson and Henry Schein (two of the largest distributors in the country) yield no results [5][6].
Claim 1, in summary:
There is no independent evidence that Shunyata or Clear Image Scientific operates as a legitimate medical device manufacturer. The available materials suggest this claim is simply marketing.
Claim 2: Shunyata products are used in hospitals across the United States.
This claim is also highly questionable. Shunyata asserts that their “CIS Model-6” power conditioner is in use at electrophysiology labs in at least ten U.S. hospitals. Of the ten “case studies” displayed on the CIS website, only four include photos of lab setups—and only one case study shows the Model-6 unit itself integrated into the lab setup [1]. For case studies intended to showcase their product, the near-absence of any visual evidence is telling. Notably, one photo labeled as the Deborah Heart & Lung Center lab actually has a file name referencing a different doctor and hospital cited elsewhere in their materials [3].
In addition, there are no independent sources corroborating Shunyata’s claims. Outside of Shunyata’s own sites and audiophile blogs repeating their marketing, there is no evidence that these hospitals use the CIS Model-6. On PubMed (the National Institutes of Health’s biggest database for all medical information), there are zero results when searching for “Shunyata Research”, “Clear Image Scientific”, or “CIS Model-6” [7].
Claim 2, in summary:
There is no credible evidence—beyond Shunyata’s own unsubstantiated marketing—that their products are in use in any hospital.
Claim 3: Shunyata products are highly reviewed by doctors who have used them.
This claim does not withstand scrutiny. The only positive reviews or testimonials from doctors appear exclusively on Shunyata’s own website [1][2]. None of these endorsements can be found on any independent source. No hospital websites, professional medical organizations, or peer-reviewed journals mention Shunyata or Clear Image Scientific products, let alone praise their performance or utility [7]. For legitimate medical devices, it is routine to find at least some independent evaluation or discussion in clinical literature, conference proceedings, or within medical society guidelines; in this case, there is none.
Furthermore, even within Shunyata’s own case studies, attributions are vague and sometimes inconsistent, and at least one photo was mislabeled or reused, casting further doubt on their authenticity [4]. This absence of independent and verifiable reviews is especially concerning in a field where new medical equipment must be subject to rigorous evaluation and scrutiny. At the time of writing, I have written to some of the doctors mentioned in these case studies for clarification (under a pseudonym for anonymity), but have not received any responses.
Claim 3, in summary:
There is no independent evidence that any doctors or hospitals have publicly endorsed Shunyata/CIS products. The available “reviews” are limited to Shunyata’s own unsubstantiated marketing content.
Claim 4: Shunyata has “submitted to the Heart Rhythm Society Medical Journal” the results from doctors using their power conditioner in hospitals.
This claim is carefully worded to avoid outright falsehood. Shunyata only claims to have “submitted” data, not published it. However, a thorough search of the Heart Rhythm Society (HRS) journal database for any mention of “CIS Model-6”, “Clear Image Scientific”, “Shunyata”, or “power conditioner” finds no record of any publication or manuscript in the journal’s pipeline [8].
The HRS journal’s review process is not unusually long: on average, it takes 22 days to review a manuscript, 47 days from submission to acceptance, and 127 days from acceptance to publication—a total of about 174 days [9]. The earliest web evidence of Shunyata’s submission claim dates to October 2023, more than 600 days ago, far exceeding the typical publication window [10].
This leaves only three possibilities:
Shunyata’s claim relies on the ambiguity of “submission”, with no evidence of publication or even ongoing review. There is no visible record that any data was ever seriously considered by the HRS journal. The careful phrasing appears designed to create the impression of scientific legitimacy without providing any actual evidence.
Claim 5: Shunyata products are “medical-grade” and “comply with electrical safety measures required for devices that can potentially be exposed to patients and medical staff.”
This claim, like the others, is carefully worded to avoid outright medical fraud. Shunyata implies regulatory compliance but stops short of claiming formal FDA approval. In the United States, any device marketed for use in patient care must be registered with the FDA under the Federal Food, Drug, and Cosmetic Act (21 CFR Part 807) and must have either a cleared 510(k) premarket notification, Premarket Approval (PMA), or qualify for a specific exemption as a low-risk device [11].
Devices used in electrophysiology procedures—where patient safety is directly involved—are subject to especially strict requirements, and approved products are publicly listed. A thorough search of the FDA Devices@FDA database for “CIS Model-6”, “Clear Image Scientific”, or “Shunyata Research”, yields no results [12]. By contrast, many relevant devices (e.g., “Amplifier and Signal Conditioner, Biopotential,” 21 CFR 870.2050) are registered, as are even simple medical power cords for ventilators [13]. The CIS Model-6, introduced around 2015 and marketed specifically for medical use, is not listed and does not appear to be an exempt low-risk device.
Crucially, even if Shunyata/CIS products were somehow exempt from the stringent standards above, the company would still be required to register with the FDA in order to legally market their devices in the United States. A search of the FDA Establishment Registration & Device Listing database again finds no entries for “Shunyata Research”, “Clear Image Scientific”, or “Model-6” [14]. This absence is troubling, given that their own marketing claims widespread hospital use across the country.
As such, based on all publicly available FDA databases and manufacturer disclosures as of July 2025, there is no evidence that Shunyata, Clear Image Scientific, or their Model-6 device is registered, listed, or approved for medical use in the United States. If such registration exists under a different company or product name, it has not been referenced in any of their public materials or independent industry sources.
Simply stating “compliance with safety measures” is not equivalent to FDA clearance or approval. “Medical-grade” is a meaningless label without third-party certification or regulatory validation.
Claim 5, in summary:
There is no evidence that any Shunyata or CIS product has been reviewed, approved, or even registered with the FDA, as required for devices used in patient care. The claim of compliance is unsubstantiated and appears designed to create a false impression of regulatory legitimacy.
Putting Everything Together
Shunyata Research claims to have founded Clear Image Scientific to deliver advanced power conditioners and cables for sensitive electrophysiology procedures. However, a thorough examination shows that these claims are unsubstantiated by any independent or regulatory evidence.
Every significant claim regarding manufacturer status, hospital use, professional endorsements, published data, and regulatory compliance—lacks independent corroboration. Their marketing relies on ambiguous, carefully worded statements that imply legitimacy while avoiding outright falsehood. Most concerningly, there is no evidence of FDA registration, clearance, or approval for their products, as required for devices used in patient care.
Where Does This Leave Us?
If you were already skeptical of Shunyata’s claims, I hope this analysis gives you even more reason to trust your instincts—and, more importantly, gives you a one-stop reference for the next time these claims come up.
If you were on the fence because of those impressive-sounding endorsements and “medical” marketing, I hope it’s now clear how little substance actually backs them up.
And if you were at all convinced by Shunyata’s narrative, consider this: No reputable audio company should ever need to invent a fake medical division, fabricate hospital use, or rely on unverifiable testimonials to sell its products. Real engineering stands on real evidence, not smoke and mirrors.
Final Thoughts
Ultimately, Shunyata is just an audiophile company. If someone wants to spend thousands on cables for “silvery highs”, that’s their choice and their wallet.
But medicine is different. When a company claims to make devices for high-risk medical procedures, there are strict standards. As far as I can tell, Shunyata/Clear Image Scientific products have not met those standards, and that has real consequences. At minimum, any device marketed for patient care, even if exempt from stringent reviews, must be registered with the FDA. Shunyata/CIS’s failure to do so makes their claims of compliance and ‘medical-grade’ status not just unsubstantiated, but potentially unlawful.
For my part, I have already submitted an anonymous tip to the FDA with all the information discovered here. Overselling to audiophiles is one thing; bringing unregistered and unapproved devices into hospitals is another. Marketing your home audio gear using unapproved “medical” results is not just misleading, it’s dangerous.
If you work in medicine, or know someone who does, I invite you to check with the hospitals named by Shunyata in their Case Studies page. If these products truly are certified and effective, there should be documentation. But all available evidence strongly suggests otherwise. If these claims are false, and these power conditioners are not FDA-registered, then these hospitals are risking serious legal and ethical consequences for exposing patients to unregulated devices.
References
P.S.: A special shoutout goes to the person on Reddit who kept sending these bunk Shunyata links to me as proof that their investments in audiophile fuses, power conditioners, and cables, was a good thing. I’d have left them alone with those links, but as soon as they said “Shunyata makes medical devices!”, I knew I had to dig further. If there are legal consequences from this for Shunyata, they have that user on Reddit to thank, for prompting me to begin digging for the truth.
P.P.S: As for my own credentials in digging up all this stuff, I am an electrical engineer first, and a biomedical engineer second. These days, my job has been purely microchips (non-medical), but having dealt with medical devices and their regulations in the past, and having had the severity of these regulations drilled into my head, I knew something was off with these Shunyata claims. If anyone here is well-versed in medical device regulations, please let me know if anything can be improved. But between my knowledge of the mountains of red tape that go into medical device regulations, and the fact that I can’t find a shred of evidence for even the most basic of actions that medical device makers must do, in order to legally sell their products in the US, these medical claims by Shunyata can be disregarded completely as… bunk.
UPDATE (7/25/2025):
I have received confirmation from the FDA that they have successfully received my report. I have also sent out a similar report to the Joint Commission, the body that certifies accreditation for over 15,000 hospitals in America, and that will probably get the regulatory wheels going to figure out the truth.
I also made a similar post like this over on audiophile Reddit, and that post became popular enough for at least one reader to have told me they sent it to Shunyata for comment.
My Reddit post has now been deleted by “Reddit filters”. I’m not a clever man, but even I could put two and two together. Anyway, Shunyata et al can try to avoid me all they want, but wheels are rolling now that they cannot stop.
Why Bother With Shunyata Research’s Medical Claims?
Many people here already roll their eyes at Shunyata Research’s claims, and justifiably so, given the absence of any technical transparency from the company. It’s easy to ignore them as just another audiophile brand selling smoke, mirrors, and unicorn tears.
But this is different. Shunyata isn’t just targeting audiophiles, they’ve set up a so-called medical device company and now claim their noise reduction technology is making hospitals and heart procedures safer. Thus, their audiophile business gets the added boost of being “endorsed” by doctors and hospitals across the United States.
You might wonder: Why bother digging deeper when the marketing is obviously suspect? It’s easy to assume Shunyata just set up a fake medical company to bolster their audiophile business.
That could well be true, but to my knowledge, no one has ever done a full deep dive into these claims. That changes today. If you were suspicious before but didn’t have time to look into this, this writeup provides the facts you need. If you’ve already done some digging, this adds more detail. And if you’ve seen enough to dismiss their claims, this can be your reference for the future—no need to hunt down the facts again.
Whether you’re a skeptic, on the fence, or just curious, my goal is to present the facts. This isn’t just about debunking more audio nonsense; it’s about exposing claims that cross the line from silly to genuinely dangerous.
If you want the short answer: the evidence so far says these medical device claims don’t hold up. For the details, read on.
The Claims
Shunyata Research, along with its medical device affiliate Clear Image Scientific, makes the following claims:
- They are a manufacturer of medical devices for power conditioning and noise reduction in cardiac electrophysiology labs.
- Their products (power cables and a power conditioner) are used in various hospitals across the United States.
- Their products have been highly reviewed by doctors at these hospitals, including several experts in the field of cardiac electrophysiology.
- The results and improvements delivered by their power conditioning products have been “submitted to the Heart Rhythm Society Medical Journal”.
- Their products are “medical-grade,” and “comply with electrical safety measures required for devices that can potentially be exposed to patients and medical staff” [1][2].
Claim 1: Shunyata makes power conditioners and power cables for cardiac electrophysiology labs.
This claim is highly questionable. For a supposedly legitimate company, the website created for Clear Image Scientific (CIS) is extremely barebones. The “About Us” page contains almost no information; the “Designer Background” page is copied directly from Shunyata’s audio website. “Technology” and “Products” pages recycle generic marketing language from their consumer audio business, without sufficient technical documentation or clinical data [3]. The “Case Studies” are vague [4], and the only contact for the entire company is Shunyata’s own sales director.
Genuine medical device manufacturers will provide regulatory information (FDA/CE/ISO), technical specifications, product documentation, clinical data, support resources, purchasing channels, and legal disclosures. The CIS website lacks virtually all of these, suggesting it serves as a placeholder to prop up Shunyata’s legitimacy in the audio industry, rather than a functioning medical device company.
In the same vein, if Shunyata/CIS were a legitimate medical device manufacturer, their products would likely be available through independent medical suppliers and distributors. However, a Google search for their “CIS Model-6” returns only Shunyata or CIS pages. Searches on major U.S. medical distributors such as McKesson and Henry Schein (two of the largest distributors in the country) yield no results [5][6].
Claim 1, in summary:
There is no independent evidence that Shunyata or Clear Image Scientific operates as a legitimate medical device manufacturer. The available materials suggest this claim is simply marketing.
Claim 2: Shunyata products are used in hospitals across the United States.
This claim is also highly questionable. Shunyata asserts that their “CIS Model-6” power conditioner is in use at electrophysiology labs in at least ten U.S. hospitals. Of the ten “case studies” displayed on the CIS website, only four include photos of lab setups—and only one case study shows the Model-6 unit itself integrated into the lab setup [1]. For case studies intended to showcase their product, the near-absence of any visual evidence is telling. Notably, one photo labeled as the Deborah Heart & Lung Center lab actually has a file name referencing a different doctor and hospital cited elsewhere in their materials [3].
In addition, there are no independent sources corroborating Shunyata’s claims. Outside of Shunyata’s own sites and audiophile blogs repeating their marketing, there is no evidence that these hospitals use the CIS Model-6. On PubMed (the National Institutes of Health’s biggest database for all medical information), there are zero results when searching for “Shunyata Research”, “Clear Image Scientific”, or “CIS Model-6” [7].
Claim 2, in summary:
There is no credible evidence—beyond Shunyata’s own unsubstantiated marketing—that their products are in use in any hospital.
Claim 3: Shunyata products are highly reviewed by doctors who have used them.
This claim does not withstand scrutiny. The only positive reviews or testimonials from doctors appear exclusively on Shunyata’s own website [1][2]. None of these endorsements can be found on any independent source. No hospital websites, professional medical organizations, or peer-reviewed journals mention Shunyata or Clear Image Scientific products, let alone praise their performance or utility [7]. For legitimate medical devices, it is routine to find at least some independent evaluation or discussion in clinical literature, conference proceedings, or within medical society guidelines; in this case, there is none.
Furthermore, even within Shunyata’s own case studies, attributions are vague and sometimes inconsistent, and at least one photo was mislabeled or reused, casting further doubt on their authenticity [4]. This absence of independent and verifiable reviews is especially concerning in a field where new medical equipment must be subject to rigorous evaluation and scrutiny. At the time of writing, I have written to some of the doctors mentioned in these case studies for clarification (under a pseudonym for anonymity), but have not received any responses.
Claim 3, in summary:
There is no independent evidence that any doctors or hospitals have publicly endorsed Shunyata/CIS products. The available “reviews” are limited to Shunyata’s own unsubstantiated marketing content.
Claim 4: Shunyata has “submitted to the Heart Rhythm Society Medical Journal” the results from doctors using their power conditioner in hospitals.
This claim is carefully worded to avoid outright falsehood. Shunyata only claims to have “submitted” data, not published it. However, a thorough search of the Heart Rhythm Society (HRS) journal database for any mention of “CIS Model-6”, “Clear Image Scientific”, “Shunyata”, or “power conditioner” finds no record of any publication or manuscript in the journal’s pipeline [8].
The HRS journal’s review process is not unusually long: on average, it takes 22 days to review a manuscript, 47 days from submission to acceptance, and 127 days from acceptance to publication—a total of about 174 days [9]. The earliest web evidence of Shunyata’s submission claim dates to October 2023, more than 600 days ago, far exceeding the typical publication window [10].
This leaves only three possibilities:
- Shunyata never actually submitted the data;
- The data was submitted but rejected;
- The manuscript has been inexplicably delayed for nearly four times the average publication timeline, which is highly unlikely.
Shunyata’s claim relies on the ambiguity of “submission”, with no evidence of publication or even ongoing review. There is no visible record that any data was ever seriously considered by the HRS journal. The careful phrasing appears designed to create the impression of scientific legitimacy without providing any actual evidence.
Claim 5: Shunyata products are “medical-grade” and “comply with electrical safety measures required for devices that can potentially be exposed to patients and medical staff.”
This claim, like the others, is carefully worded to avoid outright medical fraud. Shunyata implies regulatory compliance but stops short of claiming formal FDA approval. In the United States, any device marketed for use in patient care must be registered with the FDA under the Federal Food, Drug, and Cosmetic Act (21 CFR Part 807) and must have either a cleared 510(k) premarket notification, Premarket Approval (PMA), or qualify for a specific exemption as a low-risk device [11].
Devices used in electrophysiology procedures—where patient safety is directly involved—are subject to especially strict requirements, and approved products are publicly listed. A thorough search of the FDA Devices@FDA database for “CIS Model-6”, “Clear Image Scientific”, or “Shunyata Research”, yields no results [12]. By contrast, many relevant devices (e.g., “Amplifier and Signal Conditioner, Biopotential,” 21 CFR 870.2050) are registered, as are even simple medical power cords for ventilators [13]. The CIS Model-6, introduced around 2015 and marketed specifically for medical use, is not listed and does not appear to be an exempt low-risk device.
Crucially, even if Shunyata/CIS products were somehow exempt from the stringent standards above, the company would still be required to register with the FDA in order to legally market their devices in the United States. A search of the FDA Establishment Registration & Device Listing database again finds no entries for “Shunyata Research”, “Clear Image Scientific”, or “Model-6” [14]. This absence is troubling, given that their own marketing claims widespread hospital use across the country.
As such, based on all publicly available FDA databases and manufacturer disclosures as of July 2025, there is no evidence that Shunyata, Clear Image Scientific, or their Model-6 device is registered, listed, or approved for medical use in the United States. If such registration exists under a different company or product name, it has not been referenced in any of their public materials or independent industry sources.
Simply stating “compliance with safety measures” is not equivalent to FDA clearance or approval. “Medical-grade” is a meaningless label without third-party certification or regulatory validation.
Claim 5, in summary:
There is no evidence that any Shunyata or CIS product has been reviewed, approved, or even registered with the FDA, as required for devices used in patient care. The claim of compliance is unsubstantiated and appears designed to create a false impression of regulatory legitimacy.
Putting Everything Together
Shunyata Research claims to have founded Clear Image Scientific to deliver advanced power conditioners and cables for sensitive electrophysiology procedures. However, a thorough examination shows that these claims are unsubstantiated by any independent or regulatory evidence.
Every significant claim regarding manufacturer status, hospital use, professional endorsements, published data, and regulatory compliance—lacks independent corroboration. Their marketing relies on ambiguous, carefully worded statements that imply legitimacy while avoiding outright falsehood. Most concerningly, there is no evidence of FDA registration, clearance, or approval for their products, as required for devices used in patient care.
Where Does This Leave Us?
If you were already skeptical of Shunyata’s claims, I hope this analysis gives you even more reason to trust your instincts—and, more importantly, gives you a one-stop reference for the next time these claims come up.
If you were on the fence because of those impressive-sounding endorsements and “medical” marketing, I hope it’s now clear how little substance actually backs them up.
And if you were at all convinced by Shunyata’s narrative, consider this: No reputable audio company should ever need to invent a fake medical division, fabricate hospital use, or rely on unverifiable testimonials to sell its products. Real engineering stands on real evidence, not smoke and mirrors.
Final Thoughts
Ultimately, Shunyata is just an audiophile company. If someone wants to spend thousands on cables for “silvery highs”, that’s their choice and their wallet.
But medicine is different. When a company claims to make devices for high-risk medical procedures, there are strict standards. As far as I can tell, Shunyata/Clear Image Scientific products have not met those standards, and that has real consequences. At minimum, any device marketed for patient care, even if exempt from stringent reviews, must be registered with the FDA. Shunyata/CIS’s failure to do so makes their claims of compliance and ‘medical-grade’ status not just unsubstantiated, but potentially unlawful.
For my part, I have already submitted an anonymous tip to the FDA with all the information discovered here. Overselling to audiophiles is one thing; bringing unregistered and unapproved devices into hospitals is another. Marketing your home audio gear using unapproved “medical” results is not just misleading, it’s dangerous.
If you work in medicine, or know someone who does, I invite you to check with the hospitals named by Shunyata in their Case Studies page. If these products truly are certified and effective, there should be documentation. But all available evidence strongly suggests otherwise. If these claims are false, and these power conditioners are not FDA-registered, then these hospitals are risking serious legal and ethical consequences for exposing patients to unregulated devices.
References
- Shunyata Research, “Medical” page (current): https://shunyata.com/medical/
- Clear Image Scientific website (current): https://clearimagescientific.com/
- Clear Image Scientific Model-6 product page (current): https://clearimagescientific.com/products/cis-model-6/
- Clear Image Scientific “Case Studies” page (current): https://clearimagescientific.com/case-studies/
- Henry Schein, Medical distributor, database search for Clear Image Scientific: https://www.henryschein.com/us-en/Search.aspx?searchkeyWord=”Clear+Image+Scientific”
- McKesson, Medical-Surgical distributor, database search for “Clear Image Scientific: https://mms.mckesson.com/catalog?query="Clear+Image+Scientific"
- PubMed: https://pubmed.ncbi.nlm.nih.gov/
- Heart Rhythm Society Journal: https://www.heartrhythmjournal.com/
- ScienceDirect journal metrics for the HRS Journal: https://www.sciencedirect.com/journal/heart-rhythm
- Shunyata Research, “Medical” page (archived, Oct 2023): https://web.archive.org/web/20231001130350/https://shunyata.com/medical/
- FDA guidance on how to classify medical devices: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
- FDA Devices@FDA database: https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm
- Ventilator power cord listed on Devices@FDA: https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K060549
- FDA Establishment Registration & Device Listing database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
P.S.: A special shoutout goes to the person on Reddit who kept sending these bunk Shunyata links to me as proof that their investments in audiophile fuses, power conditioners, and cables, was a good thing. I’d have left them alone with those links, but as soon as they said “Shunyata makes medical devices!”, I knew I had to dig further. If there are legal consequences from this for Shunyata, they have that user on Reddit to thank, for prompting me to begin digging for the truth.
P.P.S: As for my own credentials in digging up all this stuff, I am an electrical engineer first, and a biomedical engineer second. These days, my job has been purely microchips (non-medical), but having dealt with medical devices and their regulations in the past, and having had the severity of these regulations drilled into my head, I knew something was off with these Shunyata claims. If anyone here is well-versed in medical device regulations, please let me know if anything can be improved. But between my knowledge of the mountains of red tape that go into medical device regulations, and the fact that I can’t find a shred of evidence for even the most basic of actions that medical device makers must do, in order to legally sell their products in the US, these medical claims by Shunyata can be disregarded completely as… bunk.
UPDATE (7/25/2025):
I have received confirmation from the FDA that they have successfully received my report. I have also sent out a similar report to the Joint Commission, the body that certifies accreditation for over 15,000 hospitals in America, and that will probably get the regulatory wheels going to figure out the truth.
I also made a similar post like this over on audiophile Reddit, and that post became popular enough for at least one reader to have told me they sent it to Shunyata for comment.
My Reddit post has now been deleted by “Reddit filters”. I’m not a clever man, but even I could put two and two together. Anyway, Shunyata et al can try to avoid me all they want, but wheels are rolling now that they cannot stop.
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