Tuesday, May 2, 2023

Health Misinformation

With the abundance of health information available today, it can be hard to tell what is true or not. We all need access to trusted sources of information to stay safe and healthy.

Why health misinformation matters


We can all benefit from taking steps to improve the quality of the health information we consume. Limiting misinformation helps us make more educated decisions for ourselves, our loved ones, and our communities.

Health misinformation is a serious threat to public health. It can cause confusion, sow mistrust, harm people’s health, and undermine public health efforts.”
Dr. Vivek H. Murthy

Vivek Mirthy M.D.Surgeon General of the United StatesThe Rest of IT


Monday, May 1, 2023

Physician Unionizing How, Why, Who? SMHS residents and fellows vote to unionize – The GW Hatchet

Medical residents and fellows at the School of Medicine and Health Sciences voted overwhelmingly to unionize Thursday.

SMHS residents and fellows voted 253-16 Wednesday and Thursday join the Committee of Interns and Residents — a subsidiary unit of the Service Employees International Union. Maryssa Miller, a physician who helped organize the unionization effort, said the union will form a bargaining committee in the coming weeks representing residents’ departments like internal medicine, emergency medicine, and obstetrics and gynecology.



Every year some group of physicians organizes to form a union. Most often they are not successful. The reasons are many.



George Washington University School of Medicine and Health Sciences is no worse than any other academic center.

1. Trainees have a limited time span 1-3 years in a position where they are subject to abuse.
2. A moral and ethical imperative to care for a patient, no matter the circumstance in hospital.

Always a point of contention is the long hours and difficulties for physician trainees.

COVID-19 exacerbated the intense work and long hours for all caregivers, including physicians.

Physicians' Unions have rarely gained strength in the United States.  Perhaps the worst working conditions exist in academic settings.

Trainees are in a captive and at times abusive environment.  This has been a never-ending story. Forty years ago when I was a trainee it was even worse.  At times I would work 36-hour shifts.  Today in 2023 Academic residency programs are required to abide by rules regarding training hours, limiting the work week to no more than 80 hours.

Medical residents and fellows at the School of Medicine and Health Sciences voted overwhelmingly to unionize Thursday.

SMHS residents and fellows voted 253-16 Wednesday and Thursday to join the Committee of Interns and Residents — a subsidiary unit of the Service Employees International Union. Maryssa Miller, a physician who helped organize the unionization effort, said the union will form a bargaining committee in the coming weeks representing residents’ departments like internal medicine, emergency medicine, and obstetrics and gynecology.
A recent report from the American Council for Graduate Medical Education reveals that despite the rules many institutions are being cited for infractions. 

Some specialties were cited more often, Internal Medicine, Family Practice Transitional year (Internship). It is common practice for trainees in the initial year of training to be expected to carry a disproportionate workload.  The reasons are a subordinate position as related to superiors, and the necessity to acquiesce to unreasonable demands to ensure being advanced to the next level of training.

What is the ACGME 16-hour rule?

In July 2011, the Accreditation Council for Graduate Medical Education (ACGME) reduced the consecutive number of hours that post-graduate year-1 residents can work in a single shift, from 30 to 16. This rule was intended to improve patient safety by reducing residents' fatigue.

It has been over ten years since this guideline was recommended by the ACGME.  Ongoing examination reveals there has been considerable resistance to the ACGME guidelines. 

Why is this? 

The demands of clinical care are ongoing, 24/7/365/. It is a bit like 7-11.   The relative shortage of physicians creates an undeniable demand for those working in the system.  There is no reasonable solution for this confounding fact.  The result would be a lack of physicians for a considerable portion of patients in the hospital.  Can you imagine a patient needing emergency surgery at night and there would be no surgeon available?

Pros of Unionization

Unions provide an integrated and time-proven methodology of negotiations between employees and employers by an experienced third party

Cons

A Union introduces factors and dues whether you decided or not that prospective union members may not have factored into their voting.




SMHS residents and fellows vote to unionize – The GW Hatchet

Sunday, April 30, 2023

Where is the Pain ?

 

Why do we reduce humans who suffer from chronic pain to simple molecules and receptors? Pain psychologist Rachel Zoffness, P.h.D. returns to talk about fibromyalgia, stomach pain, anxiety, the role of trauma, and much more.

Dr. Rachel Zoffness is a Health and Pain Psychologist, international speaker, author, and thought-leader in pain medicine. She is an Assistant Clinical Professor at the UCSF School of Medicine, a Stanford lecturer, and a Mayday Fellow. Her podcast episodes on The New York Times Ezra Klein Show, Ologies (Dolorology), and The Jordan Harbinger Show are viral sensations with more than 6 million views and downloads.

Dr Zdogg, as he is known is Zubin Damania MD a graduate of UC San Francisco. His background is in intensive care and primary care.  ZdoggMD is well known on the YouTube circuit. 


Dr. Z's book, links to our prior interview, audio podcast, and full transcript:

The Pain Management Workbook: Powerful CBT and Mindfulness Skills to Take Control of Pain and Reclaim Your Life

Rachel Zoffness, P.h.D. examines the segments of the pain mechanism in this video.

Key Topics:

0:00 Intro
1:14 The bio-psycho-social nature of pain: phantom limb pain, the limbic system & emotion-pain connection, social contributors
9:00 The stigma of “psychological” pain and holistic approaches to managing it
16:15 The concept of “pain volume” and how emotional states affect it
18:56 Releasing negative emotion: the idea of “tea-kettling”
26:21 Fibromyalgia & trauma, pain amplification and “central sensitization”
33:14 The importance of desensitization practices for chronic pain
36:14 The benefits and risks of narcotics, the danger of removing them too fast
40:41 Sympathetic nervous system, the interaction of trauma and adverse childhood experiences (ACEs)
47:44 Placebo & the mind-body connection
53:34 Anxiety/Depression and Overmedicalization by Big Pharma
1:00:00 Non-pharmacologic treatments for pain, anxiety, and depression
1:04:06 The mind-gut connection: Irritable Bowel Syndrome, performance anxiety, and more
1:11:14 Emotional repression, fear of speaking and exposure therapy, PTSD
1:18:28 Imposter Syndrome and Dunning-Kruger effect, gender roles (vocal fry/uptalk)
1:25:00 The Problem of emotional repression, and Solutions
1:28:37 How biofeedback works

Why do people experience pain in a limb that is missing? (Phantom Limb Pain)

Pain causes angst, anxiety, and physiological effects.  What is the connection between the psycho-biological-emotional aspects of pain?


Wednesday, April 26, 2023

CMS cracks down on prior authorization requirements in MEDICARE ADVANTAGE plans


Tension has developed between CMS and their Medicare Advantage Plans.



Whose prior authorization is it anyway? MA plans are contracted to provide insurance benefits via a private contract. Strictly speaking, MA plans are not the same as fee-for-service Medicare. The goal was to reduce Medicare costs by contracting with groups and/or private insurers (ie, Humana. Aetna and smaller insurance entities (local). These MA plans are paid a contract amount for covering the same benefits as FFS Medicare.  In some cases, this is an FFS arrangement with the MA plan.

In order to contain costs prior authorizations are used to filter out unnecessary tests, or procedures.
In real life, this serves to deny coverage, and at the least increases costs for the providers. (more personnel to process prior authorizations.  In some cases, additional insurance billers are required for at least 1 FTE, or more in some cases for group practices. The cost has been absorbed by the provider.

Medicare Advantage (MA) plans will find it harder to require prior authorizations for their coverage under a new final rule from the Centers for Medicare and Medicaid Services (CMS).


CMS says the new rule, announced on April 5, is intended to address MA member complaints that the plan’s prior authorization requirements restrict their access to care. In response, the rule will:
limit the use of coordinated care MA plans’ prior authorization policies to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary,
prohibit coordinated care MA plans from requiring prior authorizations for an active course of treatment for at least 90 days when a patient switches MA plans, require all MA plans to establish utilization management committees to ensure consistency with Traditional Medicare’s national and local coverage decisions and guidelines, and require that prior authorization approvals remain valid “for as long as medically reasonable and necessary to avoid disruptions in care in accordance with applicable coverage criteria, the patient’s medical history, and the treating provider’s recommendation.”
“Together, these changes will help ensure enrollees have consistent access to medically- necessary care while also maintaining medical management tools that emphasize the important role MA plans play in coordinating medically-necessary care,” CMS said.

The rule comes in the wake of a 2022 report from the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services that found that some MA plans have been denying prior authorization requests even though the requests met Medicare coverage rules.

The OIG report also found that plans were denying payments to providers for some services that met both Medicare coverage and the MA plan’s own billing rules.

Physicians’ groups hailed the rule. “Family physicians know first hand how this will help ensure timely access to care while alleviating physicians’ administrative burdens and patients’ care delays,” American Academy of Family Physicians President Tochi Iroku-Malize, MD, FAAFP, said in a tweet.

 




CMS rule cracks down on prior authorization requirements in MA plans

Tuesday, April 25, 2023

Abortion A Tale of Two Lawsuits - by Jessica Valenti

Politics has no place in healthcare.  How the world turned.
 
Congress, when it formed Medicare inserted a message that Medicare could not practice medicine and would not interfere with professional judgment.  That did not last very long.  Soon new regulations imposed restrictions on treatments.  

When Medicare in 1965 went into effect professional medical organizations warned that open and free access to medical care would bankrupt the country in short order.  

It is a conundrum to deliver health care to all who need it since demand is infinite and supply is limited. Health care has its own algorithm outside of the free market enterprise.

NHE Fact Sheet.  (National Health Expenditure Data)

As decades have passed the percentage of the GDP has risen to 18%, although at a slower rate due to balanced budget restrictions.

Historical NHE, 2021:

NHE grew 2.7% to $4.3 trillion in 2021, or $12,914 per person, and accounted for 18.3% of Gross Domestic Product (GDP).

Medicare spending grew 8.4% to $900.8 billion in 2021, or 21 percent of total NHE.

Medicaid spending grew 9.2% to $734.0 billion in 2021, or 17 percent of total NHE.

Private health insurance spending grew 5.8% to $1,211.4 billion in 2021, or 28 percent of total NHE.
Out-of-pocket spending grew 10.4% to $433.2 billion in 2021 or 10 percent of total NHE.

Other Third Party Payers and Programs and Public Health Activity spending declined 20.7% in 2021 to $596.6 billion, or 14 percent of total NHE.

Hospital expenditures grew 4.4% to $1,323.9 billion in 2021, slower than the 6.2% growth in 2020.

Physician and clinical services expenditures grew 5.6% to $864.6 billion in 2021, slower growth than the 6.6% in 2020.

Prescription drug spending increased 7.8% to $378.0 billion in 2021, faster than the 3.7% growth in 2020.

The largest shares of total health spending were sponsored by the federal government (34 percent) and the households (27 percent). The private business share of health spending accounted for 17 percent of total health care spending, state and local governments accounted for 15 percent, and other private revenues accounted for 7 percent.

Projected NHE, 2021-2030:

On average over 2021-30, National Health Expenditures (NHE) and Gross Domestic Product (GDP) are both projected to grow 5.1 percent per year; as a result, the projected NHE share of GDP in 2030 (19.6 percent) is similar to 2020 (19.7 percent).

Near-term NHE patterns are significantly influenced by the COVID-19 pandemic.  NHE growth in 2021 is projected to have slowed to 4.2 percent (down from 9.7 percent growth in 2020) as federal COVID-19 supplemental funding declined substantially. 

Following the declines observed in 2020, healthcare utilization is expected to rebound starting in 2021 and normalize through 2024.  By 2024, the government's (federal and state & local) share of health spending is expected to fall to 46 percent as COVID-19 supplemental funding is expected to wane, down from an all-time high of 51 percent in 2020.

The percentage of the population with health insurance is expected to peak in 2022 at 91.1% (mainly due to Medicaid enrollment) before falling back towards pre-pandemic levels as the public health emergency is assumed to end.  The 2030 rate is projected to be 90.5%.

For 2025-2030, factors that typically drive changes in health spending and enrollment, such as economic, demographic, and health-specific factors, are again expected to primarily influence trends in the health sector.




The Judicial Branch has now stepped in to overrule Congress and the Federal Drug Administration attempting to overrule scientific decisions.  Not only that they are conflicting rulings between state jurisdictions.  Legal maneuvering delays treatment plans.
 
Two federal courts —one in Washington and one in Texas—issued conflicting rulings on mifepristone, one of the two drugs used for medication abortions. Matthew Kacsmaryk, the Trump-appointed federal judge in Texas, ruled to invalidate the FDA approval of mifepristone (with a stay of 7 days)—a decision we anticipated after the hearing earlier this spring. But a Washington federal judge, who also has the power to bind the FDA, ruled that the FDA shouldn’t restrict mifepristone and that the role of an Article III judge is not to second guess the expertise of the FDA.




This is important: Both have equal bearing over abortion access going forward. And medically-safe sources of medication abortion pills, including mifepristone, are still available, despite the ruling out of Texas. Fear is just as strong of a tool in the anti-abortion movement as any legal ruling.


To get a clearer picture of what the two conflicting federal opinions mean and what the FDA and the Biden administration can do to protect mifepristone, Abortion, Every Day went to law professors Greer Donley and Rachel Rebouche—who have been leading the national conversation on abortion medication and the FDA approval process since Roe fell.



A Tale of Two Lawsuits - by Jessica Valenti

Monday, April 24, 2023

Line up children, the COVID sniffing dog is here to judge you

A recent paper in JAMA Pediatrics shows how badly adults dehumanized children.

Commentary from the author:

                                   Commentary :  Ten hours of dog sniffing
 
A recent paper in JAMA Pediatrics shows how badly adults dehumanized children. Before I explain, as background, I work as a health care provider in California. During the pandemic, I never had to asymptomatically test even during hospital work. No dog ever smelled me. Keep that in mind as I tell you about this. Because these CA kids have more restrictions than doctors working in the hospital with the sickest patients!

It strikes me as a bit dehumanizing to treat children like this. Especially since ~100% would later go on to develop COVID. The vast majority would get COVID without getting a vaccine. Seems that lining them up in the schoolyard, and having a dog sniff them— something I have only been subject to in airports, where I assume they are sniffing for bomb residue or drugs— is a bit extreme.

I worry how a child might feel if they go to school feeling fine, and the dog sits down beside them. Their classmates— even though they are told to face away— will still know. The dog will stop moving. And let’s be honest, kids will look around. Did they pull the kid from school then? Did any kids start crying? Seems messed up to me. Why did they have to do this with children?

Why do I note this: isn’t it something that not a single person flagged this idea and said: if we are going to do this, let’s do it for doctors or nurses, or at least adults. It is kinda fucked up to treat children like this, and future generations may look at us like we are out of our minds. When they look back at the IFR in kids, they may think we are actually insane.

Regardless of a pandemic emergency, this sort of behavior is unconscionable.  These children are in the protective custody of the school.  There is no mention of parental consent for involuntary testing.  Were the parents even notified beforehand?

The article also did not mention what was done if a child tested as positive. 

What I don't know is whether individual parents complained or protested about this event.  I assume if the testing was done in the schoolyard (probably in the morning) the child wouldn't be permitted to enter the school.

If this was done during the masking mandate why would they still test if kids were masked?

This procedure raises many more questions than answers.

The article was published by authors in California so I assume the testing was done there.

This was obviously done for deriving data for a public health study rather than protecting innocent children.

I am also certain the authorities used the Public Health Emergency Order by the State of California, the Governor, and all others who use immunity as a protection against legal action.

What do you think? Reasonable or messed up?

I predict it will only get worse.

Just remember,  "We're doing this for your protection"












Line up children, the COVID sniffing dog is here to judge you

AskAnExpert: Anesthesia 101 SCIENCE FRIDAY NPR

AskAnExpert: Anesthesia 101 (SciFri Zoom Call-in)



Your surgeon recommends you have surgery. He gives you an informed consent form and asks you to sign it.  

Are you signing your life away? He/she explains the risks and benefits of the procedure and should also tell you what can happen if you don't have the surgery.

What other risks do you face ? If general or local anesthesia is necessary you should be aware of those risks as well.  They can be substantial and usually, the anesthetist should explain them in an informed consent separate from the consent form given to you by the surgeon's office. But caution is advised because some hospitals or ASCs do not do this.  If there is an adverse event or even death if this has not b been explained the perpetrators are open to clear-cut malpractice/negligence, separate from the surgeon's liability.

Contrary to what most people think, going to sleep is not the same as anesthesia.

This video clearly explains those risks. 

Tuesday, April 11, 2023

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap | HHS.gov

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap | HHS.gov

HJR 7 - Relating to a national emergency declared by the President on March 13, 2020. Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That, pursuant to section 202 of the National Emergencies Act (50 U.S.C. 1622), the national emergency declared by the finding of the President on March 13, 2020, in Proclamation 9994 (85 Fed. Reg. 15337) is hereby terminated.   https://www.whitehouse.gov/briefing-room/legislation/2023/04/10/bill-signed-h-j-res-7/

What does this mean?

There are other laws passed by Congress that leaves in place certain actions.

Biden rescinding Trump-Biden Proclamation 9994 under the 1976 National Emergencies Act does not terminate Azar Becerra’s Public Health Emergency authorities under the 1983 PHE amendment to the 1944 PHSA.

Under the terms of. 1944PHSA, U.S. Congressional law still permits emergency quarantines for ensuing epidemics, or results of biological warfare or terrorism.

President Joe Biden on April 10 signed a measure that immediately ended the COVID-19 national emergency more than three years after it was enacted, the White House announced.

HJ Res 7 passed through the Senate on March 29 by a 68-23 margin, with 21 Democrats joining 47 Republicans to support the measure. 

Four Republicans and five Democrats did not cast a vote—and 23 Democrats voted against the short resolution—which was introduced by Rep. Paul Gosar (R-Ariz.) last month and passed by the House 229-197 on Feb. 1.

Concerned citizens should be aware that the terms of declaring a national emergency due to infectious disease outbreaks remain vague, leaving it open to interpretation by politicians, and local, tribal, and state government officials.


There are certain rules regarding the roles of Federal, State, and local government which introduce possible competing and adversarial roles for quarantine and enforcement.

If a quarantinable disease is suspected or identified, CDC may issue a federal isolation or quarantine order.

Public health authorities at the federal, state, local, and tribal levels may sometimes seek help from police or other law enforcement officers to enforce a public health order.

U.S. Customs and Border Protection and U.S. Coast Guard officers are authorized to help enforce federal quarantine orders.

Breaking a federal quarantine order is punishable by fines and imprisonment.

Federal law allows the conditional release of persons from quarantine if they comply with medical monitoring and surveillance.

In the rare event that a federal order is issued by CDC, those individuals will be provided with an order for quarantine or isolation. An example of a Quarantine Order for Novel Coronavirus (print-only) [PDF – 5 pages] is provided. This document outlines the rationale of the federal order as well as information on where the individual will be located, quarantine requirements including the length of the order, CDC’s legal authority, and information outlining what the individual can expect while under federal order.


The United States was ill-prepared for COVID-19.  Conflicting advice from individuals, governors, and others led to confusion and a lack of trust on the part of the American people.

In addition to the above the First Amendment allowed mis- information to be propagated by social media. This has and will continue in the future without strict guidelines to monitor misinformation via the internet. This will require massive monitoring of internet traffic, using Artificial Intelligence. The First Amendment could be used to strike down internet monitoring.  Who will set the standards for what is correct or not?  Will there be penalties for internet abuse?

There are many issues to be decided before the next epidemic.

Wednesday, April 5, 2023

Dreaded Medical Paperwork Required by Health Insurers to Be Trimmed - WSJ

UnitedHealthcare, Cigna and Aetna move to revamp prior-authorization programs.


The paperwork required by health insurers to get many medical procedures or tests—one of the biggest gripes of doctors and patients—is getting rolled back.

UnitedHealth Group Inc.’s UnitedHealthcare, the largest health insurer in the U.S., said Wednesday it would cut its use of the prior authorization process. Starting in the third quarter, it will remove many procedures and medical devices from its list of services requiring signoff.

I go into a great deal about his issue in my Substack article Dreaded Medical Paperwork Required by Health Insurers to Be Trimmed



For more than two decades patients have heard their physician say I will have to obtain “prior authorization” from your insurance company for this test, drug, or treatment. The paperwork required by health insurers to get many medical procedures or tests—one of the biggest gripes of doctors and patients—is getting rolled back.

This is a major advance in eliminating physician ‘burnout’. Besides the use of electronic health records, many physicians have abandoned their dream of being doctors. Many have said this has become a moral dystopia for providers. For patients, it has meant delays in necessary treatments, causing anxiety, worsening health, and rarely death. It will eliminate stacks of paperwork, and endless waiting on hold to speak to an insurance representative.

Angus Worthing, a rheumatologist in Washington, D.C., whose practice has to employ roughly one prior-authorization-focused staffer for every two doctors, said. Patients typically wait two to four weeks to get medications under the process, he said, and while they wait, he sometimes needs to put them on other drugs that cause side effects. Several decades ago it was presumed that doctors ordered too many tests, and at times treatments that had no evidence for improvement of health. Prior authorizations were thought to decrease these occurrences. Initially, this had the immediate effect to reduce utilization.

Continue reading....... 










Dreaded Medical Paperwork Required by Health Insurers to Be Trimmed - WSJ: Prior authorization has generated so much resentment in recent years that some health insurers have been making tweaks.

Monday, April 3, 2023

Coverage for Preventive Services Struck Down

Holy healthcare, Batman!

Toni Brayer, MD who writes in Every Thing Health

The Texan judiciary strikes again.  



You have probably forgotten that Obamacare (the Affordable Care Act) ensured that Health Insurance Companies cover preventive services.  This includes immunizations, screening tests for cancer (mammograms, colon cancer, prostate cancer), blood pressure, diabetes, and cholesterol tests, physical exams and well-baby, well-child visits, HIV, and mental health services.  Americans have benefited from this mandated coverage since 2010.


A Federal judge in Texas, who once said the ACA was unconstitutional, has struck down the requirement that preventive care be covered and that decision could affect more than 150 million people who would lose these "free" services. I say "free" because they are now covered under the exorbitant premiums that Insurance companies charge. 

Insurers say that they will not claw back on this coverage that people have come to expect.  But I see changes in formularies, co-pays, deductibles, and requirements for pre-authorization that seem to change month by month.  I have absolutely no doubt that these preventive services will be whittled away one by one if this ruling is allowed to remain.  

The ruling stemmed from a case brought by six individuals and two Christian-owned businesses who argued that they should not be mandated to offer coverage of HIV PrEP because they did not want to encourage "homosexual behavior."

Why make this change for these small businesses ? Do they want to "damn" those who have contracted HIV or prevent it? Has the Vatican taken a stand on this?  

 "Instead of attacking the coverage that patients have, we should be looking for ways to bolster the ACA and increase access to care." The US repeatedly ranks last in health outcomes compared to other industrialized nations and this will further widen the gap. 

Today (Friday, March 31), President Biden appealed the decision and it will be heard in the US Fifth Circuit Court of Appeals. "All preventive services are kind of up for grabs as we go through the appeals process," said Laurie Sobel, associate director for women's health policy at Kaiser Family Foundation.


 It may ultimately go to the US Supreme Court. 

Let's see of the rule of law overturns common sense and the Affordable Care Act.

Malignancy may start small but always metastasizes


Wednesday, March 8, 2023

Abbott's lab-based blood test for concussion scores FDA nod


Two years after Abbott landed FDA clearance for a hand-held blood test that could detect signs of mild traumatic brain injuries (TBIs) in the span of about 15 minutes, the concussion-spotting test is heading to the big leagues.

The FDA has now cleared a version of the diagnostic that’s designed to run on Abbott’s Alinity i laboratory instruments. Because the Alinity systems are installed in hospitals and labs across the U.S., the regulatory clearance vastly scales up the availability of the test for the millions of Americans who experience concussions every year, Abbott noted in its Tuesday announcement. This vastly increases accessibility for clinicians from their office.  The test is already available outside the U.S., having reeled in CE mark approval in Europe at the end of 2021.

The lab test works by analyzing a blood sample drawn from the arm. It looks for two biomarkers in the blood, both of which have been closely linked to TBIs when found in elevated concentrations. In studies, it was able to churn out results with 96.7% sensitivity and 99.4% negative predictive value, per Abbott.

The test returns results within about 18 minutes and has been authorized to assess patients aged 18 and older within 12 hours of a suspected concussion. It’s meant to be used as a triaging step before a CT scan, following a physician’s assessment of a patient’s visual, verbal and motor responses—which is often the only test they undergo before being sent off for a confirmatory CT scan.

According to Abbott, using the test as a first step in diagnosing concussion can help reduce the number of unnecessary CT scans performed on patients without actual brain injuries by as much as 40%—and will therefore cut down on the amount of time they need to spend in a hospital’s emergency department—while also flagging the patients who do need further imaging to confirm a concussion.

The newly FDA-cleared diagnostic offers a high-throughput alternative to Abbott’s i-STAT TBI Plasma test, which was given the green light to spot signs of traumatic brain injuries at the start of 2021.

That version of the concussion-detecting blood test runs on the i-STAT Alinity platform, a smartphone-sized, hand-held device that’s able to separate out plasma from a blood sample and conduct its biomarker analysis within 15 minutes.

A study published last year looked at the pair of biomarkers measured in both versions of the TBI test. After examining test results and longer-term outcome data for nearly 1,700 patients, the researchers concluded that higher concentrations of those biomarkers were linked to a higher probability of severe disability and death within six months of the initial brain injury.




SyncThink clocks FDA nod for concussion test based on AI-powered eye tracking

This device mimics the usual test of following a finger test given by an emergency room physician. Using AI it measures more accurately abnormal eye tracking movement and creates a graphic representation of the eye movement.

The Eye-Sync platform from SyncThink uses AI to analyze the results of a series of fast-paced eye-tracking assessments, in tandem with standard neurocognitive tests, patient records and reported symptoms, to determine the type and severity of cognitive dysfunction caused by a head injury.

The technology previously received 510(k) clearance from the FDA in 2016 for use in detecting impairments in patients’ gaze and visual tracking abilities. The new clearance extends the platform’s indications, allowing healthcare providers in the U.S. to use it to help diagnose both concussion and mild traumatic brain injury.

The Eye-Sync platform from SyncThink uses AI to analyze the results of a series of fast-paced eye-tracking assessments, in tandem with standard neurocognitive tests, patient records and reported symptoms, to determine the type and severity of cognitive dysfunction caused by a head injury.

The technology previously received 510(k) clearance from the FDA in 2016 for use in detecting impairments in patients’ gaze and visual tracking abilities. The new clearance extends the platform’s indications, allowing healthcare providers in the U.S. to use it to help diagnose both concussion and mild traumatic brain injury.

SyncThink isn’t the only medtech developer attempting to clear the thorny pathway to concussion diagnosis.


BrainScope, for one, added an FDA-cleared, concussion-detecting algorithm of its own to its point-of-care brain-scanning headset in March. The Concussion Index analyzes multiple EEG readings from the headset to monitor the progression of traumatic injuries, hidden bleeds and concussions.

Abbott, too, has thrown its hat in the ring. In January, the FDA doled out yet another clearance for concussion detection, this time for Abbott’s i-STAT Alinity platform, a hand-held rapid blood-testing system that measures the amount of certain proteins in the bloodstream after a head injury to determine whether further testing is required.




Abbott's lab-based blood test for concussion scores FDA nod