News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

New Wearable In-Ear Medical Device Helps Sufferers of Standing-Related Ailments

Device is latest example that wearable healthcare devices are moving past simple biomarker monitoring and into the area of assisting in rehab

Companies unrelated to traditional clinical laboratory medicine continue to develop wearable devices that enable individuals to monitor their health while also alerting physicians and caregivers in real time when certain biomarkers are out of range.

One recent example is US biotechnology company STAT Health Informatics in Boston, which has developed a wearable device that monitors blood flow to the ear and face “to better understand symptoms such as dizziness, brain fog, headaches, fainting, and fatigue that occur upon standing,” according to a press release. The tiny device is worn in the ear and connects wirelessly to a smartphone app.

Johns Hopkins University clinically tested the STAT device, and according to Medical Device Network, “It can predict a person fainting minutes before it happens and can be worn with more than 90% of devices that go in or around the ear. It can also be left in while sleeping and showering, meaning less likelihood of removing the device and forgetting to replace it.”

Another notable aspect of this invention is that it’s an example of how the ongoing miniaturization of various technologies makes it possible to invent smaller devices but with greater capabilities. In the case of the STAT device, it combines tiny sensors, Bluetooth, and an equally tiny battery to produce a device that fits in the ear and can function for up to three days before needing a recharge.

It’s easy to imagine these technologies being used for other types of diagnostic testing devices that could be managed by clinical laboratories.

Johns Hopkins published its findings in the Journal of the American College of Cardiology: Clinical Electrophysiology titled, “Monitoring Carotid Blood Flow Using In-Ear Wearable Device During Tilt-Table Testing.”

Daniel Lee

“It’s well understood that the ear is a biometric gold mine because of its close proximity to the brain and major arteries. This allows for new biometrics … to be possible,” said Daniel Lee (above), co-founder and CEO of STAT Health, in a press release. “In addition, the ear is largely isolated from data corruption caused by arm motion—a problem that plagues current wearables and prevents them from monitoring heart metrics during many daily tasks. The ear is really the ideal window into the brain and heart.” Clinical laboratory managers may want to watch how this technology is further developed to incorporate other biomarkers for diseases and health conditions. (Photo copyright: STAT Health.)

How STAT Works

Every time the wearer stands, the STAT device tracks the change in response of blood pressure, heart rate, and blood flow to the head. “The device distills all this information into an ‘Up Score’ to track time spent upright. Its ‘Flow Score’ helps users pace their recovery by watching for blood flow abnormalities,” MassDevice reported.

According to the company’s website, STAT is intended for use in individuals who have been diagnosed with conditions known to suffer from drops in blood flow to the head, such as:

As an individual continues to use the device, STAT “learns about each user’s unique body to provide personalized coaching for healthy lifestyle choices,” MassDevice reported.

Another key factor is the technology built into the device. An optical sensor was chosen over ultrasound because STAT Health felt it was both easy to use and provided precise measurements accessing the shallow ear artery, MassDevice reported.

“Despite its small scale, the device incorporates advanced optical sensors, an accelerometer, a pressure sensor, temperature sensors, artificial intelligence (AI)-edge computing, three-day battery life (or more), and a micro solar panel,” Medical Device Network noted.

wearable device

STAT’s image above demonstrates how truly minute the company’s wearable device is, even though it monitors blood flow to the face and ear looking for signs that the wearer is about to suffer bouts of dizziness or lightheadedness due to a drop in blood flow. (Photo copyright: STAT Health Informatics Inc.)

STAT’s Impact on Users’ Health

STAT’s developers intend the device to help individuals stay on track with their health. “The target population can navigate their condition better. If they’re not standing when they can, they will become deconditioned. This product encourages standing and being upright where possible, as part of rehab,” Lee told Medical Device Network.

Lee has been developing wearable in-ear devices for many years.  

“Nobody has realized the ear’s true potential due to the miniaturization and complex systems design needed to make a practical and user-friendly ear wearable,” he told MassDevice. “After multiple engineering breakthroughs, we’ve succeeded in unlocking the ear to combine the convenience and long-term nature of wearables with the high fidelity nature of obtrusive clinical monitors. No other device comes close along the axis of wearability and cardiac signal quality, which is why we believe STAT is truly the world’s most advanced wearable.”

For clinical laboratories, though STAT is not a diagnostic test, it is the latest example of how companies are developing wearable monitoring devices intended to allow individuals to monitor their health. It moves beyond the simple monitoring of Apple Watch and Fitbit. This device can aid individuals during rehab.

Wearable healthcare devices will continue to be introduced that are smaller, allow more precise measurements of target biomarkers, and alert wearers in real time when those markers are out of range. Keeping in tune with the newest developments will help clinical laboratories and pathologists find new ways to support healthcare providers who recommend these devices for monitoring their patients conditions.

—Kristin Althea O’Connor

Related Information:

STAT Health Introduces First In-Ear Wearable to Measure Blood Flow to the Head for Long COVID, POTS and Other Related Syndromes

Monitoring Carotid Blood Flow Using In-Ear Wearable Device During Tilt-Table Testing

STAT Health Launches First In-Ear Wearable to Measure Blood Flow

Stat Health Launches In-Ear Wearable That Measures Blood Flow

University of Oxford Researchers Use Spectroscopy and Artificial Intelligence to Create a Blood Test for Chronic Fatigue Syndrome

Spectroscopic technique was 91% accurate in identifying the notoriously difficult-to-diagnose disease suggesting a clinical diagnostic test for CFS may be possible

Most clinical pathologists know that, despite their best efforts, scientists have failed to come up with a reliable clinical laboratory blood test for diagnosing myalgic encephalomyelitis (ME), the condition commonly known as chronic fatigue syndrome (CFS)—at least not one that’s ready for clinical use.

But now an international team of researchers at the University of Oxford has developed an experimental non-invasive test for CFS using a simple blood draw, artificial intelligence (AI), and a spectroscopic technique known as Raman spectroscopy.

The approach uses a laser to identify unique cellular “fingerprints” associated with the disease, according to an Oxford news release.

“When Raman was added to a panel of potentially diagnostic outputs, we improved the ability of the model to identify the ME/CFS patients and controls,” Karl Morten, PhD, Director of Graduate Studies and Principal Investigator at Oxford University, told Advanced Science News. Morton led the research team along with Wei Huang, PhD, Professor of Biological Engineering at Oxford.

The researchers claim the test is 91% accurate in differentiating between healthy people, disease controls, and ME/CFS patients, and 84% accurate in differentiating between mild, moderate, and severe cases, the new release states.

The researchers published their paper in the journal Advanced Science titled, “Developing a Blood Cell-Based Diagnostic Test for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Using Peripheral Blood Mononuclear Cells.”

Karl Morten, PhD

“This could be a game changer as we are unsure what causes [ME/CFS] and diagnosis occurs perhaps 10 to 20 years after the condition has started to develop,” said Karl Morten, PhD, Director of Graduate Studies and Principal Investigator at Oxford University. “An early diagnosis might allow us to identify what is going wrong with the potential to fix it before the more long-term degenerative changes are observed.” Though this research may not lead to a simple clinical laboratory blood test for CFS, any non-invasive diagnostic test would enable doctors to help many people. (Photo copyright: Oxford University.)

Need for an ME/CFS Test

The federal Centers for Disease Control and Prevention (CDC) describes ME/CFS as “a serious, long-term illness that affects many body systems,” with symptoms that include severe fatigue and sleep difficulties. Citing an Institute of Medicine (IoM) report, the agency estimates that 836,000 to 2.5 million Americans suffer from the condition but notes that most cases have not been diagnosed.

“One of the difficulties is the complexity of the disease,” said Jonas Bergquist, MD, PhD, Director of the ME/CFS Research Center of Uppsala University in Sweden, told Advanced Science News. “Because it’s a multi-organ disorder, you get symptoms from many different regions of the body with different onsets, though it’s common with post viral syndrome to have different overlapping [symptoms] that disguise the diagnosis.” Bergquist was not involved with the Oxford study.

One key to the Oxford researchers’ technique is the use of multiple artificial intelligence models to analyze the spectral profiles. “These signatures are complex and by eye there are not necessarily clear features that separate ME/CFS patients from other groups,” Morten told Advanced Science News.

“The AI looks at this data and attempts to find features which can separate the groups,” he continued. “Different AI methods find different features in the data. Individually, each method is not that successful at assigning an unknown sample to the correct group. However, when we combine the different methods, we produce a model which can assign the subjects to the different groups very accurately.”

Without a reliable test, “diagnosis of the condition is difficult, with most patients relying on self-report, questionnaires, and subjective measures to receive a diagnosis,” the Oxford press release noted.

But developing such a test has been challenging, Advanced Science News noted.

How Oxford’s Raman Technique Works

Raman spectroscopy uses a laser to determine the “vibrational modes of molecules,” according to the Oxford press release.

“When a laser beam is directed at a cell, some of the scattered photons undergo frequency shifts due to energy exchanges with the cell’s molecular components,” the press release stated. “Raman micro-spectroscopy detects these shifted photons, providing a non-invasive method for single cell analysis. The resulting single cell Raman spectra serve as a unique fingerprint, revealing the intrinsic and biochemical properties and indicating the physiological and metabolic state of the cell.”

The researchers employed the technique on blood samples from 98 subjects, including 61 ME/CFS patients, 16 healthy controls, and 21 controls with multiple sclerosis (MS), Advanced Science reported.

The Oxford scientists focused their attention on peripheral blood mononuclear cells (PBMCs), as previous studies found that these cells showed “reduced energetic function” in ME/CFS patients. “With this evidence, the team proposed that single-cell analysis of PBMCs might reveal differences in the structure and morphology in ME/CFS patients compared to healthy controls and other disease groups such as multiple sclerosis,” the press release states.

Clinical Laboratory Blood Processing and the Oxford Raman Technique

Oxford’s Raman spectroscopic technique “only requires a small blood sample which could be developed as a point-of-care test perhaps from one drop of blood,” the researchers wrote. However, Advanced Science News pointed out that required laser microscopy equipment costs more than $250,000.

In their Advanced Science paper, the researchers note that the test could be made more widely available by transferring blood samples collected by local clinical laboratories to diagnostic centers that have the needed hardware.

“Alternatively, a compact system containing portable Raman instruments could be developed, which would be much cheaper than a standard Raman microscope, and [which] incorporated with microfluidic systems to stream cells through a Raman laser for detection, eliminating the need for lengthy blood sample processing,” the researchers wrote.

They noted that the technique could be adapted to test for other chronic conditions as well, such as MS, fibromyalgia, Lyme disease, and long COVID.

“Our paper is very much a starting point for future research,” Morten told Advanced Science News. “Larger cohorts need to be studied, and if Raman proves useful, we need to think carefully about how a test might be developed.”

Bergquist agreed, stating it’s “not necessarily something you would see in a doctor’s office. It requires a lot of advanced data analysis to use—I still see it as a research methodology. But in the long run, it could be developed into a tool that could be used in a more simplistic way.”

Though a useable diagnostic test may be far off, clinical laboratories should consider how they can aid in ME/CFS research.

—Stephen Beale

Related Information:

First Steps Towards Developing a New Diagnostic Test to Accurately Identify Hallmarks of Chronic Fatigue Syndrome in Blood Cells

First Ever Diagnostic Test for Chronic Fatigue Syndrome Sparks Hope

Developing a Blood Cell-Based Diagnostic Test for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Using Peripheral Blood Mononuclear Cells

Blood Test for Chronic Fatigue Syndrome Found to Be 91% Accurate

Scientists Develop Blood Test for Chronic Fatigue Syndrome

Biomarkers for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A Systematic Review

Biomarker for Chronic Fatigue Syndrome Identified

In Early Weeks of Flu Season, COVID-19 Patients Show Milder Symptoms as SARS-CoV-2 Continues to Evolve

Doctors report difficulty differentiating COVID-19 from other viral infections, impacting clinical laboratory test orders

Because the SARS-CoV-2 coronavirus is in the same family of viruses that cause the common cold and influenza, virologists expected this virus—which caused the global COVID-19 pandemic—would evolve and mutate into a milder form of infection. Early evidence from this influenza season seems consistent with these expectations in ways that will influence how clinical laboratories offer tests for different respiratory viruses.

While new variants of the SARS-CoV-2 virus continue to appear, indications are that early in this flu season individuals infected with the more recent variants are experiencing milder symptoms when compared to the last few years. Doctors report they find it increasingly difficult to distinguish COVID-19 infections from allergies or the common cold because patients’ symptoms are less severe, according to NBC News.

This, of course, makes it challenging for doctors to know the most appropriate clinical laboratory tests to order to help them make accurate diagnoses.

Erick Eiting, MD

“It isn’t the same typical symptoms that we were seeing before. It’s a lot of congestion, sometimes sneezing, usually a mild sore throat,” Erick Eiting, MD, Vice Chair of Operations for Emergency Medicine at Mount Sinai Hospital in New York City, told NBC News. “Just about everyone who I’ve seen has had really mild symptoms. The only way that we knew that it was COVID was because we happened to be testing them.” Knowing which tests for respiratory viruses that clinical laboratories need to perform may soon be the challenge for doctors. (Photo copyright: Mt. Sinai.)

Milder COVID-19 Symptoms Follow a Pattern

Previous hallmarks of a COVID-19 infection included:

  • Loss of taste,
  • loss of smell,
  • dry cough,
  • fever,
  • sore throat,
  • diarrhea,
  • body aches,
  • headaches.

However, physicians now observe milder symptoms of the infection that follow a distinct pattern and which are mostly concentrated in the upper respiratory tract

Grace McComsey, MD, Vice President of Research and Associate Chief Scientific Officer at University Hospitals Health System (UH) in Cleveland, Ohio, told NBC News that some patients have described their throat pain as “a burning sensation like they never had, even with Strep in the past.”

“Then, as soon as the congestion happens, it seems like the throat gets better,” she added.

In addition to the congestion, some patients are experiencing:

  • headache,
  • fever,
  • chills,
  • fatigue,
  • muscle aches,
  • post-nasal drip. 

McComsey noted that fatigue and muscle aches usually only last a couple of days, but that the congestion can sometimes last a few weeks. She also estimated that only around 10-20% of her newest COVID patients are losing their sense of smell or taste, whereas early in the pandemic that number was closer to 60-70% of her patients. 

Doctors also noted that fewer patients are requiring hospitalization and that many recover without the use of antivirals or other treatments.

“Especially since July, when this recent mini-surge started, younger people that have upper respiratory symptoms—cough, runny nose, sore throat, fever and chills—99% of the time they go home with supportive care,” said Michael Daignault, MD, an emergency physician at Providence Saint Joseph Medical Center in Burbank, California.

Milder SARS-CoV-2 Variants Should Still be Taken Seriously

Doctors have varying opinions regarding why the current COVID-19 variants are milder. Some believe the recent variants simply aren’t as good at infecting the lungs as previous variants.

“Overall, the severity of COVID-19 is much lower than it was a year ago and two years ago,” Dan Barouch, MD, PhD, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told NBC News. “That’s not because the variants are less robust. It’s because the immune responses are higher.”

McComsey added that she doesn’t think mild cases should be ignored as she is still seeing new cases of long COVID with rapid heart rate and exercise intolerance being among the most common lingering symptoms. Re-infections also add to the risks associated with long COVID.

“What we’re seeing in long COVID clinics is not just the older strains that continue to be symptomatic and not getting better—we’re adding to that number with the new strain as well,” McComsey said. “That’s why I’m not taking this new wave any less seriously.”

Clinical Laboratory COVID-19 Testing May Decrease

According to Andrew Read, PhD, Interim Senior Vice President for Research and Evan Pugh University Professor of Biology and Entomology at Pennsylvania State University, there is nothing unexpected or startling about the coronavirus acquiring new mutations.

“When a mutation confers an interesting new trick that’s got an advantage, it’s going to be popping up in many different places,” Read told the New York Times. “Everything we see is just consistent with how you imagine virus evolution proceeding in a situation where a new virus has jumped into a novel host population.”

Data from the Centers for Disease Control and Prevention’s COVID-19 Data Tracker—which reports weekly hospitalizations, deaths, emergency department (ED) visits, and COVID-19 test positivity results—shows infection trends fluctuating, but overall, they are decreasing.

  • For the week of October 21, 2023, there were 16,186 hospitalizations due to COVID-19 compared to the highest week recorded (January 15, 2022) with 150,674 hospitalizations nationwide.
  • The highest number of deaths reported in a single week were 25,974 for the week of January 8, 2021, while 637 patients perished from COVID-19 during the week of October 21, 2023.
  • In January of 2021, COVID accounted for 13.8% of all ED visits and in October 2023, COVID-19 was responsible for 1.3% of ED visits. 

“What I think we’re seeing is the virus continuing to evolve, and then leading to waves of infection, hopefully mostly mild in severity,” Barouch told The New York Times.

As severity of COVID-19 infections continues to fall, so, presumably, will demand for COVID-19 testing which has been a source of revenue for clinical laboratories for several years.

—JP Schlingman

Related Information:

Sore Throat, Then Congestion: Common COVID Symptoms Follow a Pattern Now, Doctors Say

COVID Continues to Rise, but Experts Remain Optimistic

What Is the Order of COVID Symptoms This Fall?

COVID Symptoms Now Follow a Distinct Pattern, Doctors Report

How are COVID-19 Symptoms Changing?

What Are the Mild Symptoms of COVID-19, and When Should You See a Doctor?

Doctors Admit They Can’t Tell COVID Apart from Allergies or the Common Cold Anymore—Highlighting How Mild Virus has Become

The Evolution of SARS-CoV-2

UCSF Researchers Identify Genetic Mutation That Promotes an Asymptomatic Response in Humans to COVID-19 Infection

Healthcare Experts See Links Between COVID-19 and RSV as Tripledemic Pressures Ease on Hospitals and Clinical Laboratories

Some medical experts suggest an ‘immunity gap’ related to COVID-19 mitigation measures, while others point to alternative theories

Surge in fall/winter SARS-CoV-2, influenza (flu), and respiratory syncytial virus (RSV) hospitalizations and ensuing clinical laboratory test referrals—dubbed by some public health experts as a “tripledemic”—appear to have eased in the US, according to stats from the US Centers for Disease Control and Prevention (CDC), Becker’s Hospital Review reported. However, scientists are still left with questions about why the RSV outbreak was so pronounced.

Some healthcare experts point to an “immunity gap” tied to the COVID-19 pandemic, while others suggest alternative theories such as temporary immunodeficiency brought on by COVID-19. In most cases, RSV causes “mild, cold-like symptoms,” but the CDC states it also can cause serious illness, especially for infants, young children, and older adults, leading to emergency room visits, hospitalizations, and an increased demand for clinical laboratory testing.

Pulmonology Advisor reported that the disease typically peaks between December and February, but hospitalizations this season hit their peak in November with numbers far higher than in previous years. In addition to infants and older adults, children between five and 17 years of age were “being hospitalized far in excess of their numbers in previous seasons,” the publication reported.

Asuncion Meijas MD, PhD

“Age by itself is a risk factor for more severe disease, meaning that the younger babies are usually the ones that are sick-sick,” pediatrician Asuncion Mejias, MD, PhD (above), a principal investigator with the Center for Vaccines and Immunity at Nationwide Children’s Hospital in Columbus, Ohio, told MarketWatch. Now, she added, “we are also seeing older kids, probably because they were not exposed to RSV the previous season.” Clinical laboratories in hospitals caught the brunt of those RSV inpatient admissions. (Photo copyright: Nationwide Children’s Hospital.)

Did COVID-19 Cause Immunity Gap and Surge in Respiratory Diseases?

CDC data shows that hospitalization rates linked to RSV have steadily declined since hitting their peak of 5.2 per 100,000 people in mid-November. In contrast, hospitalizations linked to the flu peaked in late November and early December at 8.7 per 100,000. Hospitalizations linked to COVID 19—which still exceed those of the other respiratory diseases—reached a plateau of 9.7 per 100,000 in early December, then saw an uptick later that month before declining in the early part of January, 2023, according to the CDC’s Respiratory Virus Hospitalization Surveillance Network (RESP-NET) dashboard.

Surveillance by the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) revealed a similar pattern: An early peak in weekly numbers for emergency room visits for RSV, followed by a spike for influenza and steadier numbers for COVID-19.

So, why was the RSV outbreak so severe?

Respiratory diseases tend to hit hardest in winter months when people are more likely to gather indoors. Beyond that, some experts have cited social distancing and masking requirements imposed in 2020 and 2021 to limit the spread of COVID 19. These measures, along with school closures, had the side effect of reducing exposure to influenza and RSV.

“It’s what’s being referred to as this ‘immunity gap’ that people have experienced from not having been exposed to our typical respiratory viruses for the last couple of years, combined with reintroduction to indoor gatherings, indoor venues, indoor school, and day care without any of the mitigation measures that we had in place for the last couple of years,” infectious disease expert Kristin Moffitt, MD, of Boston Children’s Hospital told NPR.

Term ‘Immunity Debt’ Sparks Controversy

Other experts have pushed back against the notion that pandemic-related public health measures are largely to blame for the RSV upsurge. Many have objected to the term “immunity debt,” a term Forbes reported on in November.

“Immunity debt is a made-up term that did not exist until last year,” pediatrician Dave Stukus, MD, wrote on Twitter. Stukus is a Professor of Clinical Pediatrics in the Division of Allergy and Immunology at Nationwide Children’s Hospital in Columbus, Ohio.

An article published by Texas Public Radio (TPR) suggests further grounds for skepticism, stating that “the immunity debt theory doesn’t seem to hold up to scrutiny.”

Pediatrician and infectious disease expert Theresa Barton, MD, of UT Health San Antonio noted that there was also a big RSV surge in summer of 2021.

“That was sort of the great unmasking, and everybody got viral illnesses,” she told TPR. “Now we’re past that. We’ve already been through that. We should have some immunity from that and we’re having it again.”

She added that “the hospital is filled with babies who are less than a year of age who have RSV infection. Those children weren’t locked down in 2020.”

The story also noted that not all Americans complied with social distancing or masking guidelines.

“We’re not seeing [less viral illness in] states in the United States that were less strict compared to states that were stricter during mask mandates and things like that. All the states are being impacted,” Barton told TPR.

Perfect Storm of Demand for Clinical Laboratory Testing

Barton suggested that COVID-19 might have compromised people’s immune systems in ways that made them more susceptible to other respiratory diseases. For example, a study published in Nature Immunology, titled, “Immunological Dysfunction Persists for Eight Months following Initial Mild-to-Moderate SARS-CoV-2 Infection,” found that some patients who survived COVID-19 infection developed post-acute long COVID (LC, aka, COVID syndrome) which lasted longer than 12 weeks. And that “patients with LC had highly activated innate immune cells, lacked naive T and naive B cells, and showed elevated expression of type I IFN (IFN-β) and type III IFN (IFN-λ1) that remained persistently high at eight months after infection.”  

Experts speaking to The Boston Globe said that multiple factors are likely to blame for the severity and early arrival of the RSV outbreak. Pediatric hospitalist and infectious disease specialist Chadi El Saleeby, MD, of Massachusetts General Hospital, said the severity of some cases might be tied to simultaneous infection with multiple viruses.

Clinical laboratories experienced a perfect storm of infectious disease testing demands during this tripledemic. Hopefully, with the arrival of spring and summer, that demand for lab tests will wane and allow for a return to a normal rate of traditional laboratory testing.

Stephen Beale

Related Information:

This Year’s RSV Surge: Bigger, Earlier, and Affecting Older Patients than Previous Seasonal Outbreaks

Experts Explain the ‘Perfect Storm’ of Rampant RSV and Flu

Flu, COVID-19 and RSV are All Trending Down for the First Time in Months

COVID, Flu, RSV Declining in Hospitals As ‘Tripledemic’ Threat Fades

COVID-19 May Be to Blame for the Surge in RSV Illness Among Children. Here’s Why.

Is Immunity Debt or Immunity Theft to Blame for Children’s Respiratory Virus Spike?

Don’t Blame ‘Immunity Debt’ If You Get Sick This Winter

Claims of an Immunity Debt in Children Owe Us Evidence

Some are Blaming ‘Immunity Debt’ for the ‘Tripledemic’—But Experts Disagree

Rapid Tests for COVID, RSV and the Flu are Available in Europe. Why Not in the US?

;