Image Credit: BiVACOR
In a revolutionary medical achievement, an Australian man with end-stage heart failure became the first person in the world to walk out of a hospital after undergoing a total artificial heart implant. The pioneering surgery, performed at Sydney's St. Vincent's Hospital, is a significant breakthrough in cardiology, providing hope for thousands of patients globally on the waiting list for heart transplants.
The patient, a 40-year-old man who wished to be unidentified, spent more than 100 days with the artificial heart before undergoing a donor heart transplant in early March. This historic success supports the promise of the BiVACOR Total Artificial Heart (TAH) as an alternative for long-term replacement for people with advanced heart failure.
Created by Dr. Daniel Timms, the BiVACOR TAH is a groundbreaking medical device designed to replace a failing human heart entirely. In contrast to conventional heart pumps that augment the heart's work, this device fully assumes the function of both ventricles and provides a constant and regulated flow of blood.
One of the most important technological advancements of the BiVACOR heart is its application of magnetic levitation. The machine has a single mobile component—a rotor that is kept suspended by magnets, doing away with mechanical bearings or valves that might break down with time. This not only increases durability but also replicates the natural rhythm of the human heart, providing perfect circulation to the body and lungs.
Cardiovascular diseases are the primary killer of humans worldwide and account for about 18 million deaths annually, states the World Health Organization. Heart failure, usually a complication of diseases like coronary artery disease, heart attack, and diabetes, makes the heart so weak it cannot pump blood effectively anymore.
For end-stage biventricular heart failure patients, donor transplants are their sole chance of survival. Alas, donor hearts are always in short supply compared to the demand. Within the United States alone, nearly 3,500 heart transplants were completed in 2024, with 4,400 new additions to the waiting list. That gap leaves thousands of patients with no viable chance of treatment and underscores the desperate need for such alternatives as artificial hearts.
The BiVACOR TAH is still in the initial clinical trials, but its success to date seems to hold hope for future patients with serious heart disease. The recent Australian patient's case is the longest recorded survival time of a patient with the device, demonstrating its potential for sustaining a patient until they can receive a viable donor heart.
Victor Chang Cardiac Research Institute Professor Chris Hayward, who guided the recovery of the Australian patient, termed the advancement "a whole new ball game for heart transplants." According to him, within the next ten years, artificial hearts might be a practical option for patients who cannot be provided with a donor heart in time.
Though the Australian case is a milestone, the BiVACOR device has also been under trial elsewhere in the world. The U.S. Food and Drug Administration's Early Feasibility Study has already witnessed five patients getting the artificial heart implanted successfully. The first of these trials was conducted in July 2023, when a 58-year-old man at the Texas Medical Center got the implant. While he lived for just eight days before the transplant with a donor heart, the trial showed the device was capable of keeping critically ill patients alive.
Clinical trials will grow to 15 patients, with further tests on the device's safety and efficacy. Meanwhile, Monash University's Artificial Heart Frontiers Program, an AU$50 million ($31 million) project, is in full swing developing and commercializing three devices to treat heart failure, including the BiVACOR TAH.
Successful use of the BiVACOR artificial heart has the potential to change the management of heart failure around the globe. For those not a candidate for heart transplants or with prolonged waiting lists, this technology represents a new hope. In contrast to mechanical pumps that merely supplement failing hearts, an entirely operational artificial heart might change survival rates and quality of life for thousands of patients.
Although more studies are required prior to widespread usage, the Australian breakthrough is an important milestone in the direction of a future when artificial hearts will be a normal treatment. The more technology is developed and more clinical trials that are conducted, the closer one comes to achieving the dream of replacing a defective human heart with a long-lasting, life-extending device.
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Three British Airways cabin members were taken to the hospital after they ate marijuana-laced sweets handed to them by a passenger during a flight from London Heathrow to Los Angeles.
The staffers were unaware that the sweets contained up to 300mg of THC, the main psychoactive compound in weed a produces the psychoactive effect.
The affected members are said to have had 'out-of-body experiences' after unknowingly consuming the weed-laced gummies. The airline has now launched an investigation to find the passenger who gave the crew member the marijuana edibles.
"It is a godsend in this case the sweets in question were not shared out among the crew until they had arrived in the US," one source told The Sun.
"They were consumed in the crew bus after touchdown, and tired staff gratefully gobbled them up. Almost immediately BA staff realized something was wrong.
"By the time the group had reached the crew hotel, three staff members who had numerous sweets began suffering 'out-of-body' experiences. They felt totally out of control and became panicked and scared."
As a result, the entire crew had to be grounded in LA and a new team was out in place to operate the return service. The affected members were flown back on a separate service days later as passengers.
THC is essentially the compound that causes the euphoric “high” associated with cannabis. It’s commonly consumed through smoking cannabis, edibles, tinctures, and capsules. THC also offers medical benefits but is more likely to cause psychoactive side effects.
Known for helping with nausea, appetite stimulation, chronic pain, and insomnia, this FDA-approved edible is used in synthetic forms (like dronabinol) for treating chemotherapy-induced nausea and appetite loss in conditions like AIDS.
THC can cause temporary effects like dry mouth, red eyes and increased heart rate. Long-term use, especially in adolescents, may be linked to psychiatric issues such as anxiety or low motivation.
While CBD is not intoxicating but has mild psychoactive properties, such as promoting relaxation, THC, however, directly binds to brain receptors, causing euphoria or a “high.
Furthermore, THC disrupts normal brain function, affecting memory, learning, and attention, especially in developing adolescent brains. It can cause acute panic, anxiety, and, in some cases, induce psychosis.
Along with this, it impairs coordination, slows reaction time, and alters judgment, directly contributing to motor-vehicle accidents.
Frequent use of marijuana has been previously linked to a higher risk of developing schizophrenia or other psychoses in people who are predisposed to these conditions.
According to the American Health Association, smoking cannabis also causes respiratory issues such as lung irritation and coughing as well as increases heart rate and blood pressure, which can raise the risk of heart attacks or strokes.
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Erythritol sweetener, commonly found in most of the food we consume, whether it is a protein bar or energy drink could be linked to stroke risk. While it is considered as a safer alternative to sugar as a natural sweetener, a study from the University of Colorado suggests it could damage cells in the blood-brain barrier.
The blood-brain barrier is brain's security system that keeps the harmful substance off the limits, while letting in nutrients. Research also suggests that it would lead to serious consequences for heart health and stroke risk.
In the latest study, researchers exposed cells that form the blood–brain barrier to erythritol levels typically seen after consuming a soft drink sweetened with the compound. What followed was a cascade of cellular damage that could leave the brain more vulnerable to blood clots, one of the leading causes of stroke.
The researchers found that erythritol triggered intense oxidative stress, overwhelming cells with unstable molecules known as free radicals. At the same time, it weakened the body’s natural antioxidant defences. This double hit impaired normal cell function and, in some cases, led to cell death.
Damage to blood–brain barrier cells is particularly concerning because this barrier plays a crucial role in protecting the brain from harmful substances circulating in the bloodstream. When its integrity is compromised, the risk of neurological injury rises sharply.
Even more troubling was erythritol’s effect on how blood vessels regulate blood flow. Healthy blood vessels constantly adjust their width—expanding when organs need more oxygen and nutrients, and narrowing when demand is lower.
This process depends on a delicate balance between two molecules: nitric oxide, which relaxes blood vessels, and endothelin-1, which causes them to constrict. The study found that erythritol disrupted this balance by reducing nitric oxide production while increasing endothelin-1 levels.
The result is blood vessels that stay constricted longer than they should, potentially restricting blood flow to the brain. This kind of dysfunction is a known warning sign for ischaemic stroke, the most common form of stroke caused by blocked blood vessels.
The most alarming finding in the study was how body's natural protect against blood clot is disturbed. Under normal circumstances, cells release a substance called tissue plasminogen activator, which is described as a natural 'clot buster', which helps dissolve clots before they become dangerous. However, erythritol could interfere with this protective mechanism and allow clots to persist and cause damage.
Several have shown that people with higher blood levels of erythritol face significantly increased risks of cardiovascular events. In one major study, individuals with the highest erythritol levels were nearly twice as likely to suffer a heart attack or stroke.
However, researchers caution that the experiments were conducted on isolated cells rather than full blood vessels. More advanced models that better replicate human physiology will be needed to confirm the findings.
Erythritol occupies a unique space in the sweetener world. Classified as a sugar alcohol rather than an artificial sweetener, it escaped recent World Health Organization guidance discouraging artificial sweeteners for weight control. Its sugar-like taste has also made it a favorite in “keto-friendly” and sugar-free foods.
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FDA refuses to review Moderna's flu vaccine: The U.S. Food and Drug Administration (FDA) has declined to begin reviewing Moderna’s application for its experimental flu vaccine. The company made the announcement on Tuesday. The decision marks another signal of stricter vaccine oversight under the Trump administration and has already rattled investor confidence, with Moderna’s stock falling nearly 7% in after-hours trading.
Read: CDC Vaccine Schedule: Coverage Falls From 17 to 11 Diseases For Children
Moderna said the FDA’s refusal came as a surprise and contradicted feedback the company had received earlier, before it submitted the application and launched phase three trials for the vaccine, known as mRNA-1010. The company has now requested a meeting with the agency to better understand what it described as an unclear “path forward.”
According to Moderna, the FDA did not flag any safety or efficacy concerns with the vaccine itself. Instead, the agency objected to the design of the clinical trial—despite having previously signed off on it. Moderna added that the setback would not affect its financial guidance for 2026.
The experimental flu shot had shown encouraging results in phase three trials last year, successfully meeting all primary trial endpoints. At the time, Moderna positioned the stand-alone flu vaccine as a critical step toward developing a combined influenza and COVID-19 vaccine, a key long-term goal for the company.
The decision comes amid sweeping changes to U.S. immunisation policy over the past year under Health and Human Services Secretary Robert F. Kennedy Jr., who has long expressed skepticism toward vaccines. Moderna on Tuesday pointed to the FDA’s top vaccine regulator, Vinay Prasad, who returned to the agency in August after being removed earlier.
Prasad currently heads the FDA’s Center for Biologics Evaluation and Research (CBER) and has publicly argued for tighter regulatory standards for vaccines. He has also drawn controversy for comments linking child deaths to COVID-19 vaccines.
In a letter dated February 3 and signed by Prasad, the FDA stated that its refusal to review Moderna’s application was solely due to concerns about the trial’s design. Specifically, the agency objected to Moderna’s choice of comparator, arguing that comparing the experimental shot to a standard, approved flu vaccine did not represent the “best available standard of care.”
As a result, the FDA concluded that the study did not qualify as an “adequate and well-controlled” trial under its regulatory definition.
Moderna has strongly disputed this interpretation, arguing that FDA rules do not require companies to use the most advanced or highest-dose vaccine as a comparator in clinical trials.
In a statement, Moderna CEO Stéphane Bancel said the decision undermines innovation and fails to advance shared public health goals. He emphasized that the trial design had been discussed and agreed upon with CBER before the study began.
Moderna now expects the earliest possible approval for its flu shot to come in late 2026 or 2027, pending regulatory reviews across the U.S., Europe, Canada, and Australia.
The FDA declined to comment, stating it does not discuss regulatory communications with individual companies, reported CNBC.
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