In a landmark decision, the FDA greenlit two new drugs for the treatment of sickle cell disease in patients 12 and older, one of which —Vertex’s drug Casgevy — is the first approved use of genome editing technology CRISPR in the US. Bluebird Bio’s Lyfgenia also is a cell-based gene therapy, however, it uses a different gene modification technique to deliver tweaked stem cells to the patient.
Both approvals cultivate new pathways for the treatment of sickle cell disease, which is an inherited blood disorder that is characterized by red blood cells that can’t properly carry oxygen, which leads to painful vaso-occlusive crises (VOCs) and organ damage. The disease is particularly common among African Americans and, to a lesser extent, among Hispanic Americans. Bone marrow transplants are currently the only cure for sickle cell disease, but they require well-matched donors and often involve complications.
While both drug approvals use gene editing techniques, Casgevy’s CRISPR/Cas9 genome editing works by cutting out or splicing in DNA in select areas. Patients first have blood drawn so that their own stem cells can be isolated and edited with CRISPR. They then undergo a form of chemotherapy to remove some bone marrow cells, so the edited stem cells can be transplanted back in a single infusion.
Both drug approvals are based on studies that evaluated the effectiveness and safety of the novel therapies in clinical patients. With Casgevy, study participants reported that they did not experience “severe VOCs” for at least 12 consecutive months during the 24-month follow-up. Similarly, patients on Lyfgenia did not experience a “pain crisis” for six to 18 months after the therapy.
The FDA's decision comes shortly after UK regulators, as well as the National Health Regulatory Authority in Bahrain both approved Vertex’s Casgevy. The approval for a CRISPR-based treatment creates opportunity for further innovation in the gene editing space — for treatments ranging from cancers to heart diseases to Alzheimer’s. “Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited,” Nicole Verdun, director of the Office of Therapeutic Products at the FDA’s Center for Biologics Evaluation and Research said. Casgevy is still currently under review by the European Medicines Agency.
This article originally appeared on Engadget at https://www.engadget.com/crispr-based-gene-editing-therapy-approved-by-the-fda-for-the-first-time-200726474.html?src=rss
If you’re conscious about how we’ve been treating Mother Earth the past few years, decades, centuries, measuring carbon emissions is something that you’ve probably looked into. There are a lot of tips out there on how you can keep track of your own carbon footprint and how you can slowly lessen it. It may sometimes require a huge lifestyle change and we also need a visible tool to help us do this and see how we can help our environment recover.
Designer: YeEun Kim
The Toad House is a device that looks like a cross between an air purifier and a smart speaker but is actually something you can use to monitor how much carbon emission you’re using when you’re at home and make the necessary adjustments. It is inspired by a Korean children’s song that talks about building a new house from an old one which can be a metaphor in how we can repurpose wasted energy.
The product description can be a bit vague on how the device can actually measure your carbon emissions but it says the interface at the top of the house is where you can check how much you’re already using. This is probably connected to the app on your smartphone where you set targets and also see the values of the various appliances and gadgets in your house. It also says that the wasted power from your devices can be stored and then used for wireless charging later on.
This is still a concept for now but if it eventually becomes a product, it would be interesting to see if a gadget like this can really affect how you use energy. Eventually, there can also be studies if it indeed lessens carbon emissions when you have a visual reminder of how much you’re using and leaving in your environment. Probably what’s needed now though is more education on how people can measure their carbon footprints, at least in their personal use.
They say the best way to be consistent with something is to remove obstacles. Bought a guitar but aren’t playing it because it’s in a case? Take it out and keep it right beside your bedside so you find it easier to pick up every now and then. Got yourself a gym membership but couldn’t be bothered to go to the gym? Just get the gym to you! The guys at MAJOR FITNESS have designed what can only be described as the most comprehensive home gym ever. Designed to be attached to a wall in your house (or preferably your garage), the MAJOR FITNESS LIGHTNING F35 is a foldable gym that packs more than 80 exercises designed to target every major muscle group. It’s comprehensive, featuring a cable crossover system, a power rack, a multi-grip pull-up bar, and a landmine – everything you’d find at your nearby gym… but more importantly, it’s compact and folds right into your wall, occupying a few inches of space when not in use.
Easily one of the most compelling aspects of the MAJOR FITNESS F35 is its space-saving design. As home gyms have risen in popularity, especially in urban environments where living spaces are often compact, the need for multi-functional and space-efficient gym equipment has become more pronounced. The MAJOR FITNESS F35 is designed with this in mind, with a folding form that’s a perfect fit for apartment dwellers or those with limited space. It can seamlessly transform a small area into a comprehensive home gym, challenging the notion that effective strength training requires a large, dedicated space. The folding feature, aside from being much more intuitively designed than other wall racks (and offering 7 angles), even allows exercising in various positions, increasing versatility and variety. This puts the ball (and gym) in your court, giving you the freedom to train whenever you want right in the comfort of your home. Just try looking for an excuse now!
While many space-saving fitness solutions often cut corners in functionality, the MAJOR FITNESS F35 offers no such compromise. This folding power rack, when paired with weight plates, offers over 30 different exercises, going up to 80 different exercises when combined with additional accessories. It successfully integrates four distinct training systems: a cable crossover system, a power rack, a multi-grip pull-up bar, and a landmine. This amalgamation is not just about adding numbers to the list of possible exercises; it’s about ensuring that users can engage comprehensively with different muscle groups and workout styles.
Firstly, the cable crossover system in the F35 is a standout feature. It allows for a variety of exercises that target multiple muscle groups. Users can engage in exercises like cable flys, tricep pushdowns, and bicep curls. This system is particularly beneficial for those looking to engage in isolation exercises that focus on specific muscle groups, offering a level of workout specificity that’s often missing in home gym setups. The cable system can be both height as well as angle-adjusted (with 15 height adjustments) and has a max weight capacity of 132 lbs, offering a safe experience even for intense workouts.
Next, the power rack component of the F35 is central to its functionality. It enables classic strength training exercises such as squats, bench presses, and deadlifts. The power rack is designed to support heavy weights, catering to both beginners and advanced lifters. This feature is crucial for users focusing on compound movements that work multiple muscle groups simultaneously, providing the foundation for strength and muscle-building workouts. The J-hooks and safety arms have up to 13 different height adjustments to choose from, and the J-hook itself can withstand a whopping 660 lbs of weight for those monster deadlifts.
The multi-grip pull-up bar is another versatile feature. It accommodates a variety of grip positions – wide, narrow, and neutral – allowing users to target different parts of their upper body, especially the back, biceps, and shoulders. Exercises such as pull-ups and chin-ups are essential for developing upper body strength and are a staple in many workout routines.
Lastly, the inclusion of a landmine adds a dynamic component to the F35. This feature allows for rotational exercises that are often overlooked in standard gym setups. Users can perform landmine presses, rows, and rotational movements, which are excellent for core strengthening and functional fitness.
The MAJOR FITNESS F35 comes with a design that’s easy to assemble with no power tools or extra equipment. Written instructions, DIY setup videos, and even phone support and live-chat help allow you to assemble your MAJOR FITNESS F35 without any hiccups. Its IKEA-like construction allows it to ship flat-packed, where you can then unpack and install it in a jiffy, securing it to a wall for extra stability and anchoring. Once installed, your home gym is ready for you and even a partner or a buddy to use simultaneously. Double pulleys (one on each side) allow you to have a shared workout with your friend or partner when you’re not spotting each other. All this in the privacy of your home, without those annoying gym memberships and crowded, sweaty gyms.
Your F35 comes in 3 color options – grey, black, and red. When folded, it measures 83.8 inches tall, 68.5 inches wide, and 20.9 inches deep, opening up to 103.9 inches wide and 56.3 inches deep when fully opened. Each MAJOR FITNESS F35 comes with a 3-year warranty on the product. You can grab yours for as low as $849 (which also includes the customs fee), with the MAJOR FITNESS F35 delivering this month (November 2023) with 48-hour expedited shipping for US customers… that’s just in time for your New Year fitness resolution!
Some of the hesitation in seeing a doctor regularly for checkups comes from embarrassment and fear, often because of people who are physically present during the consultation. The recent pandemic has made virtual consultations popular, but you still have to visit a clinic or hospital to actually perform tests like blood work or biometric scans. With today’s technologies, however, that shouldn’t even be necessary, at least for the most basic tests and diagnostics. Putting that theory into practice, this forward-looking cubical room combines advanced tools and everyone’s favorite special sauce, AI, to offer a “self-serve” clinic that can be set up almost anywhere so that people can have easier and less stressful access to healthcare.
We’re all advised to get regular checkups, especially when we start to feel something’s amiss. Unfortunately, access to healthcare services isn’t always easy or convenient. Clinics might be far away or doctors might have very long waiting times. Wouldn’t it be nice if you could just walk into a room, use a few gadgets and gizmos, receive a quick diagnosis of your health, and maybe even get a legit prescription, all without even having to even physically meet with the physician? That’s the kind of quick and stress-free experience that the Forward CarePod is promising as the world’s first “AI Doctor’s Office.”
CarePod puts you in the driver’s seat of your health, almost literally considering the comfy chair inside the single-person room. You walk inside, answer a few tests to determine the kind of clinical test that needs to be done, and you use the provided tools to perform those tests, like drawing blood, swabbing your throat, taking your blood pressure, and the like. These are frontline clinical diagnostics that most nurses and doctors perform but can now also be done by yourself with the right tools, which means there will be no doctors or nurses inside CarePods. At least not human ones.
Of course, it isn’t enough to just get your diagnostic results. You’ll need a professional to interpret those results for you, which is also the job of physicians. With the CarePod system, however, that diagnosis is made by a proprietary AI that has learned from clinical expertise and the latest medical research. In addition to providing a diagnosis, that AI also formulates care plans called “Health Apps” that will guide the patient with programs and advice to address various diseases and disorders, including diabetes, hypertension, and even depression. CarePod doesn’t eliminate human doctors from the equation completely, as they are still needed for writing prescriptions or more in-depth consultations.
Impressive as all these technologies may sound, the most important aspect of CarePod is probably the fact that it can be installed almost anywhere. It is already being deployed in malls, gyms, and offices, places where clinical services are often unavailable, but it’s not hard to imagine these rooms being installed in every street corner in the future. This would give people access to healthcare that would otherwise be out of reach, which increases their chances of living healthier and longer lives.
MIT researchers developed an ingestible capsule that can monitor vital signs including heart rate and breathing patterns from within a patient’s GI tract. The scientists also say that the novel device has the potential to also be used to detect signs of respiratory depression during an opioid overdose. Giovanni Traverso, an associate professor of mechanical engineering at MIT who has been working on developing a range of ingestible sensors, told Engadget that the device will be especially useful for sleep studies.
Conventionally, sleep studies require patients to be hooked up to a number of sensors and devices. In labs and in at-home studies, sensors can be attached to a patient’s scalp, temples, chest and lungs with wires. A patient may also wear a nasal cannula, chest belt and pulse oximeter which can connect to a portable monitor. “As you can imagine, trying to sleep with all of this machinery can be challenging,” Traverso told Engadget.
MIT
This trial, which used a capsule made by Celero Systems —A start-up led by MIT and Harvard researchers— marks the first time ingestible sensor technology was tested in humans. Aside from the start-up and MIT, the research was spearheaded by experts at West Virginia University and other hospital affiliates.
The capsule contains two small batteries and a wireless antenna that transmits data. The ingestible sensor, which is the size of a vitamin capsule, traveled through the gastrointestinal tract, and collected signals from the device while it was in the stomach. The participants stayed at a sleep lab overnight while the device recorded respiration, heart rate, temperature and gastric motility. The sensor was also able to detect sleep apnea in one of the patients during the trial. The findings suggest that the ingestible was able to measure health metrics on par with medical-grade diagnostic equipment at the sleep center. Traditionally, patients that need to get diagnosed with specific sleep disorders are required to stay overnight at a sleep lab, where they get hooked onto an array of sensors and devices. Ingestible sensor technology eliminates the need for that.
Importantly, MIT says there were no adverse effects reported due to capsule ingestion. The capsule typically passes through a patient within a day or so, though that short internal shelf life may also limit how effective it could be as a monitoring device. Traverso told Engadget that he aims to have Celetro, which he co-founded, eventually contain a mechanism that will allow the capsule to sit in a patient’s stomach for a week.
Dr. Ali Rezai, the executive chair of the West Virginia University Rockefeller Neuroscience Institute, said that there is a huge potential for creating a new pathway through this device that will help providers identify when a patient is overdosing according to their vitals. In the future, researchers even anticipate that devices could incorporate drugs internally: overdose reversal agents, such as nalmefene, could be slowly administered if a sensor records that a person’s breathing rate slowed or stopped. More data from the studies will be made available in the coming months.
This article originally appeared on Engadget at https://www.engadget.com/mit-tests-new-ingestible-sensor-that-record-your-breathing-through-your-intestines-224823353.html?src=rss
In a landmark decision, the UK’s Medicines and Healthcare products Agency (MHRA) approved the use of a gene-editing therapy called Casgevy for patients with sickle cell disease and beta thalassemia — both of which are hereditary disorders related to genetic mutations of the red blood cells. The treatment, manufactured by Vertex, is the first-ever approved therapy that utilizes CRISPR-based gene editing technology to treat eligible patients.
The UK approval of the novel therapy is informed by two previous global clinical trials that indicated the treatment's efficacy. 97 percent of patients using Casgevy were relieved of severe pain associated with the blood disorders for at least 12 months after treatment during the trials. The results suggest that the gene editing treatment could replace the current standard for care. Stem cell therapy and bone marrow transplants are currently the only pathways to cure sickle cell disease and beta thalassemia, however, they involve a lot of risks.
Both sickle cell disease and beta thalassemia are blood disorders characterized by defective red blood cells that can’t carry oxygen, and require patients to get monthly blood transfusions that can be costly and time-consuming. Casgevy works by specifically targeting the genes in the bone marrow stem cells that produce faulty blood cells. For the treatment to work, a patient’s stem cells need to be extracted from their bone marrow, edited in a lab and then re-infused into the patient.
Despite its promising outlook, CRISPR-based therapies may not be easily available to the general public. Gene editing is an expensive endeavor. The Innovative Genomics Institute (IGI) estimates that the average CRISPR-based therapy will cost between $500,000 and $2 million per patient. The IGI has built out an ‘Affordability Task Force’ to tackle the issue of expanding access to these novel therapies.
Casgevy is still being reviewed by regulatory agencies for safety standards in other countries, including the United States and Saudi Arabia. A marketing application, the first step towards approval for the therapy, was recently validated by the European Medicines Agency.
This article originally appeared on Engadget at https://www.engadget.com/uk-authorizes-first-gene-therapy-for-treating-sickle-cell-disease-184130989.html?src=rss
In a trial run by Verve Therapeutics, a Cambridge–based biotech company, researchers discovered that a single infusion of a gene-editing treatment called VERVE-101 was able to reduce cholesterol levels in patients. This treatment was tested in individuals with hereditary conditions that made them susceptible to developing clogged arteries and heart attacks. Scientists were able to use CRISPR editing techniques to tweak liver gene cells. The researchers “turned off” a cholesterol-raising gene called PCSK9, which is found in the liver, in order to lower LDL-C — sometimes called "bad" cholesterol — which causes plaque to build up in arteries in the first place.
PCSK9 was lowered by as much as 84 percent in the cohorts that received higher infusion rates of the treatment. At those higher treatment doses, Verve scientists said that the reduction of those LDL-C-related proteins lasted 2.5 years in previous studies on primates.
Verve Therapeutics
From a clinical standpoint, this gene editing therapy has the potential to disrupt the current standard treatment for high cholesterol. The current go-to's include prescription statins and PCSK9 inhibitors, but they require strict adherence and can have bad side effects like muscle pain and memory loss.
CRISPR, while seemingly miraculous, is a long way from replacing daily medications though. According to Nature, two of the 10 participants in the study suffered from a “cardiovascular event” that coincided with the infusion. Verve says one was not related to the treatment at all and the second was “potentially related to treatment due to proximity to dosing.” The use of a gene-editing technology will always carry some risk because the edits could occur elsewhere in the genome.
Before a single infusion therapy for high cholesterol can reach consumers, the FDA mandates that the treatment will need to be studied for up to 15 years. Verve recently received FDA clearance for an Investigational New Drug Application for VERVE-101, meaning that the company can begin to conduct trials in the US. The current trials in New Zealand and the United Kingdom will look for willing clinical trial participants to expand the study.
This article originally appeared on Engadget at https://www.engadget.com/researchers-developed-a-gene-editing-technology-that-reduces-bad-cholesterol-170040293.html?src=rss
Amazon Prime subscribers now have access to a deeply discounted One Medical membership for primary care services. The company announced today that Prime members can sign up for just $99 a year, or $9 per month. A One Medical membership typically costs $199 annually. In addition to the individual plan, Prime members who sign up for One Medical can add up to five other people for $6 each.
Amazon announced its acquisition of One Medical in 2022 and finalized the $3.9 billion deal in February, when it began offering a temporary discount for One Medical memberships at $144 per year. It's now slashed that even further. One Medical has doctor's offices in major cities across the US, all of which will be available to Prime members who sign up. It offers all the basic health services, from annual physicals and maintenance for chronic conditions to same-day sick visits. One Medical also offers round-the-clock virtual care, or telehealth visits, and drop-in lab services. The membership doesn’t cover the cost of visits though; patients will still have to bill through their insurance or pay out of pocket.
Amazon has been pushing heavily into healthcare in recent years, with prescription services and even its own video- and text-based virtual clinic now among the perks of a Prime subscription. The company made its Amazon Clinic available to all states in the US over the summer, and began offering generic prescriptions for $5 a month with its RxPass at the beginning of the year. Amazon has also started offering drone deliveries for prescriptions in College Station, Texas.
This article originally appeared on Engadget at https://www.engadget.com/amazon-prime-now-comes-with-discounted-access-to-one-medical-health-services-161500277.html?src=rss
Most people probably think that training for competitive sports is just a matter of repeating a series of exercises with increasing intensity. That, however, is an extremely simplistic and quite dangerous strategy because our bodies are just machines. Knowing when to push harder and when to stop isn’t just a matter of feeling it and athletes have to rely on medical science and equipment to properly set their pace. That can be quite costly and inconvenient, especially for budding athletes or people with active lifestyles. Fortunately, you don’t need to break your wallet or become a scientist yourself just to get the information you need at the right time, thanks to this revolutionary wearable that lets you measure your muscle’s oxygen level so that you can train more efficiently and avoid injuries at the same time.
While heart rate monitors and blood oxygen (SpO2) monitors are important health indicators, they aren’t the only factors to consider when exercising, whether it’s for an upcoming competition or simply getting into shape. Oxygen saturation in muscles or SmO2 is just as critical because it’s what draws the line between just pushing the limits and fatigue. You can be breathing normally or taking in lots of oxygen, but your muscles might not actually be getting them properly. Unfortunately, this is something that can’t be accurately measured by smartwatches or trackers, and traditional methods are either too invasive or too bulky to really help athletes. That’s where CLOMP comes in, a muscle oxygen measurement device that you wear around your thigh to deliver real-time data without getting in your way.
CLOMP works by utilizing medical-grade functional near-infrared spectroscopy or fNIRS, the same technology used to monitor brain activity, oxygenation, and blood flow. It works almost in the same way as SpO2 or blood oxygen sensors that shine light through the skin and measure the reflected light to determine how much oxygen is being carried by the hemoglobin and myoglobin molecules in muscles and tissues. It’s an effective way to do non-invasive Lactate Threshold (LT) tests that tell when fatigue is about to set in.
With this information at hand, you or your coach can determine the most optimal training strategy while also reducing the risk of injury. It can even measure how much fat you’re burning by correlating muscle oxygen saturation (SmO2) with O2 intake and CO2 outtake, allowing you to tailor your training intensity based on your diet and calorie goals.
Despite its advanced functionality, using CLOMP couldn’t be easier. You simply strap the exercise band or patch on your thigh and you’re literally good to go. The wearable is so lightweight and ergonomic that it won’t drag you down and add to your body’s stress. CLOMP gathers data as you train and feeds it to the CLOMP app on your connected smartphone, where this data is interpreted and presented in a way that’s easy to digest and take action on.
Like many smart health platforms today, CLOMP will be able to use this information to not only guide you but also to suggest personalized workout plans, designed with USA Triathlon certified coach Gerardo Barrios, that fit your specific body’s needs and goals.
As with many things in life, the secret to training and exercise success isn’t just a matter of working harder. You also need to be smarter and more efficient, pushing your body to the limits while reducing the risk of injuries. That requires keeping track of the different biometrics of your body, which has traditionally been costly and cumbersome to do. With the CLOMP muscle oxygen measuring device, you get a medical-grade device to get the personalized information you need in a comfortable and ergonomic wearable that helps you work your way to gold the smarter and safer way.
Most people probably think that training for competitive sports is just a matter of repeating a series of exercises with increasing intensity. That, however, is an extremely simplistic and quite dangerous strategy because our bodies are just machines. Knowing when to push harder and when to stop isn’t just a matter of feeling it and athletes have to rely on medical science and equipment to properly set their pace. That can be quite costly and inconvenient, especially for budding athletes or people with active lifestyles. Fortunately, you don’t need to break your wallet or become a scientist yourself just to get the information you need at the right time, thanks to this revolutionary wearable that lets you measure your muscle’s oxygen level so that you can train more efficiently and avoid injuries at the same time.
While heart rate monitors and blood oxygen (SpO2) monitors are important health indicators, they aren’t the only factors to consider when exercising, whether it’s for an upcoming competition or simply getting into shape. Oxygen saturation in muscles or SmO2 is just as critical because it’s what draws the line between just pushing the limits and fatigue. You can be breathing normally or taking in lots of oxygen, but your muscles might not actually be getting them properly. Unfortunately, this is something that can’t be accurately measured by smartwatches or trackers, and traditional methods are either too invasive or too bulky to really help athletes. That’s where CLOMP comes in, a muscle oxygen measurement device that you wear around your thigh to deliver real-time data without getting in your way.
CLOMP works by utilizing medical-grade functional near-infrared spectroscopy or fNIRS, the same technology used to monitor brain activity, oxygenation, and blood flow. It works almost in the same way as SpO2 or blood oxygen sensors that shine light through the skin and measure the reflected light to determine how much oxygen is being carried by the hemoglobin and myoglobin molecules in muscles and tissues. It’s an effective way to do non-invasive Lactate Threshold (LT) tests that tell when fatigue is about to set in.
With this information at hand, you or your coach can determine the most optimal training strategy while also reducing the risk of injury. It can even measure how much fat you’re burning by correlating muscle oxygen saturation (SmO2) with O2 intake and CO2 outtake, allowing you to tailor your training intensity based on your diet and calorie goals.
Despite its advanced functionality, using CLOMP couldn’t be easier. You simply strap the exercise band or patch on your thigh and you’re literally good to go. The wearable is so lightweight and ergonomic that it won’t drag you down and add to your body’s stress. CLOMP gathers data as you train and feeds it to the CLOMP app on your connected smartphone, where this data is interpreted and presented in a way that’s easy to digest and take action on.
Like many smart health platforms today, CLOMP will be able to use this information to not only guide you but also to suggest personalized workout plans, designed with USA Triathlon certified coach Gerardo Barrios, that fit your specific body’s needs and goals.
As with many things in life, the secret to training and exercise success isn’t just a matter of working harder. You also need to be smarter and more efficient, pushing your body to the limits while reducing the risk of injuries. That requires keeping track of the different biometrics of your body, which has traditionally been costly and cumbersome to do. With the CLOMP muscle oxygen measuring device, you get a medical-grade device to get the personalized information you need in a comfortable and ergonomic wearable that helps you work your way to gold the smarter and safer way.
