What happened in health care technology this week, and why it’s important.
Veterans find relief from nightmares with NightWare and Apple Watch
After serving in the Army for more than 20 years with deployments to Iraq and Afghanistan, Robert Guithues developed nightmares due to PTSD. A feature article published on Apple.com Newsroom highlights the story. NightWare is a digital therapeutic system that works in conjunction with Apple Watch and iPhone to disrupt nightmares related to post-traumatic stress disorder. Available by prescription only, it’s also the first and only digital therapeutic explicitly developed to treat nightmares that is cleared by the FDA. NightWare uses information from the Apple Watch heart rate sensor, accelerometer, and gyroscope to detect a nightmare and then disrupt it through haptic feedback, generating gentle pulses on the wrist that gradually increase until the user is roused from the nightmare, but not from sleep.
“I would encourage any veteran out there who is wrestling with nightmares to give NightWare a try because there really is hope. Your life can be different, and there is something out there that I have seen work.”
Sue Baker, Semper Fi & America’s Fund caseworker
Why it’s important – Currently, NightWare is prescribed to 400 patients in the US, 98 percent of whom are active-duty military or veterans. A new study in the peer-reviewed Journal of Clinical Sleep Medicine shows that participants who used NightWare at least 50 percent of the time had significantly better self-reported sleep quality compared to participants not using NightWare. The developers believe NightWare could help so many other service members, mainly because it’s not a drug and it won’t affect their deployment status.
Infographics of the week – This is the annual update of The Top 100 Global Digital Health Companies for 2022 from Dr. Bertalan Mesko and his team at The Medical Futurist Institute. To help navigate this rapidly changing field, they keep updating their Top 100 list every year, introducing new companies they think are worthy of attention, and bid farewell to others – not necessarily because they don’t do well. Companies are grouped according to the technological trend they belong to the most. I look forward to seeing their choices every year.
The second infographic this week comes from Gist Healthcare. In it, they examine the capabilities of three of the largest pharmacy chains—CVS Health, Walgreens, and Walmart—to deliver full-service primary care across in-person and virtual settings. Excellent visual representation of the current situation.
Mobile assessment app PainChek forays into hospitals via InterSystems partnership
MobiHealthNews’ Adam Ang reports on this new partnership. PainChek, the ASX-listed developer of a mobile pain assessment app that has been widely used in the aged care sector, is now entering the global hospital market via its latest partnership with InterSystems. The platform will convert PainChek’s custom-built message formats to HL7 and FHIR standards, allowing it to scale its capacity to serve its new markets like the hospital sector, as well as home care.
Why it’s important – The PainChek app uses AI and facial recognition to detect and evaluate pain levels accurately. It has been used in over 1,300 aged care facilities in Australia, New Zealand, the United Kingdom, and Singapore. The app has been shown to facilitate improvements in pain management, with one study revealing that its adoption in aged care has led to a 20% reduction in the use of benzodiazepines and antipsychotic medications.
Podcast episode of the week – This week’s selection is from Mike Bisseli’s Passionate Pioneers podcast series and focuses on digital empathy and bedside manner in telehealth. Dr. Matt Sakumoto, virtual-first primary care physician and clinical informatics champion, joins Mike to discuss his personal experiences at multiple health systems and telehealth startups, which have led him to develop a national-leading approach to digital empathy and web-side manner for telehealth consults that are enabling care teams to better connect with patients.
Lab-grown blood given to people in world-first clinical trial
The research project combines teams in Bristol, Cambridge, London, and NHS Blood and Transplant. It focuses on the red blood cells that carry oxygen from the lungs to the rest of the body. James Gallagher reports on the research in his article on BBC online. They start with a regular donation of a pint of blood. Magnetic beads are used for fishing out flexible stem cells that are capable of becoming a red blood cell. These stem cells are encouraged to grow in large numbers in the labs. And are then guided to become red blood cells. The process takes about three weeks, and an initial pool of around half a million stem cells results in 50 billion red blood cells. These are filtered down to get approximately 15 billion red blood cells that are at the right stage of development for transplant.
“The potential for this work to benefit hard to transfuse patients is very significant.”
Dr Farrukh Shah, Medical Director of transfusion at NHS Blood and Transplant
Why it’s important – It is hoped the lab-grown blood will be more potent than normal. Red blood cells typically last for around 120 days before they need to be replaced. A typical blood donation contains a mix of young and old red blood cells, whereas the lab-grown blood is all freshly made, so it should last the full 120 days. The researchers suspect this could allow smaller and less frequent donations in the future.
“Smart” Red Blood Cells Could Deliver Antibiotics to Specific Bacteria
In another research article on blood, physicists at McMaster University have identified a natural delivery system that can safely carry potent antibiotics throughout the body to selectively attack and kill bacteria by using red blood cells as a vehicle. They modified and then tested red blood cells as a carrier for one of the world’s only remaining resistance-proof antibiotics: Polymyxin B (PmB), widely considered a treatment of last resort due to its toxicity and harmful side effects, which include kidney damage. It is used to fight particularly dangerous and often drug-resistant bacteria such as E. coli, which is responsible for many severe conditions such as pneumonia, gastroenteritis, and bloodstream infections. Researchers have developed a way to open red blood cells and remove the inner components, leaving only a membrane—known as a liposome—which can be loaded with drug molecules and injected back into the body.
Why it’s important – The platform, described in a new paper in the journal ACS Infectious Diseases, could help to address the ongoing antibiotic resistance crisis. The applications of this research go far beyond just antibiotic resistance. Scientists are working on additional applications of the technology, including its potential as a platform to deliver drugs across the blood-brain barrier and directly to the brain, helping patients with Alzheimer’s or depression, for example, to receive treatment much more quickly and directly.
Amazon’s leaked ‘Clinic’ would connect patients to telemedicine
Nicole Wetsman of The Verge posted this article reporting that Amazon might have a new healthcare offering coming soon, according to a leaked video. A video published to the company’s YouTube page Tuesday — and then quickly taken down — described “Amazon Clinic,” an online care program that would offer treatment for “common conditions” like allergies and acne. As described in the video, people could fill out a questionnaire about their symptoms and pay a fee. A clinician would review their answers and provide diagnoses and prescriptions as needed. “Telehealth services are offered by third-party healthcare provider groups,” according to the text in the video. The video directs people to amazon.com/clinic, a webpage that is not currently live at publication.
Why it’s important – The described program would be yet another healthcare pivot for Amazon. Just a few months ago, the company announced it would shutter Amazon Care, its original telehealth service. That program started as a service for Amazon employees and then was expanded as an offering for any company that wanted to offer it to its employees. The move came after Amazon announced it was acquiring primary care provider One Medical. It’s unclear if the third-party healthcare provider groups described in the Amazon Clinic video would include One Medical.
5 takeaways from the FDA’s list of AI-enabled medical devices
As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates. Elise Reuter brings us the story in her article in The Healthcare Dive. In 2022 alone, the FDA authorized 91 AI- or machine-learning-enabled medical devices, according to data released on Oct. 5. This broad category of devices can include anything from a basic algorithm to more complex machine-learning tools. Here are her five takeaways:
- The number of AI-enabled medical devices has surged in the last five years
- There are more AI tools for radiology than for any other specialty
- Most authorized devices have 510(k) clearance. However, many AI/ML devices aren’t required to be reviewed by the FDA
- GE Healthcare and Siemens have the most authorized AI/ML medical devices
- AI/ML devices will get increasingly complex with algorithms that can “learn” and regulators are looking to adapt
Why it’s important – The FDA has taken some steps to modernize how it regulates these types of devices. It has been working on a digital health pre-certification program to allow the agency to pre-clear trusted manufacturers to update their software products. However, this hasn’t been without hurdles. In a recent report, the FDA acknowledged that it would need Congressional approval to proceed with the program. (And the chances of getting Congressional approval after the midterm elections are?) Ensuring patients benefit from these devices will depend not only on regulators but also on developers involving clinicians in the earliest design steps to ensure the software is effective when integrated into their practice.
Dr. Bertalan Mesko and his team at The Medical Futurist Institute have created this infographic showing the currently cleared AI algorithms from the FDA. They have a database associated with their research which can be found here.
Wearable Health Devices Have Low Uptake Among Individuals With Heart Disease
Only 18% of US adults with cardiovascular disease (CVD) and 26% of adults at risk for CVD use wearable health devices. Individuals who need to use wearable health devices such as smart watches may actually be using them the least, according to preliminary research presented at the American Heart Association’s Scientific Sessions 2022. In comparison, 29% of the total US adult population used wearable devices.
Why it’s important – Only 12% of adults older than 65 with CVD used wearable health devices, despite half of all people with CVD being in this age group. Meanwhile, 17% of adults with CVD aged between 50 and 64 said they use wearable devices, and 33% of adults with CVD aged between 18 and 49 reported using them. Additionally, while 22% of people at risk of heart disease are aged 65 and older, only 14% of people in this age group are actually using these devices. According to the authors, this indicates an association between older age and less use of wearable devices among people with and at risk of CVD. They also found higher education level and income were linked to wearable device use.
CRISPR For Cancer Takes a Big Step Forward
Time Magazine’s Alice Park reports on a study published in Nature. Scientists recruited 16 people who had already received standard treatment for their cancer (which included colon, head and neck, lung, skin, and more) but whose cancers had returned. They wanted to use the gene-editing therapy in a new way and infuse patients with an army of immune cells that had been genetically modified to fight their individual cancers specifically.
“The CRISPR editing approach worked really well, and the guides we used cut the genome in just one place, where we removed the gene and inserted the other gene.”
Dr. Antoni Ribas, University of California Los Angeles
Scientists genetically sequenced each patient’s blood cells and tumors to determine which unique sequences of their cancers to target. They used this information to isolate the immune cells from patients’ blood whose T cell receptors matched the cancer mutations. They boosted this population of cancer-recognizing cells by making more copies of them. In this population of patient cells in the lab, they used molecular guides to instruct CRISPR to remove genetic sequences for a specific T cell receptor, which recognizes foreign proteins and replaces them with a gene that could bind to and attack cancer cells. Before introducing these CRISPR-edited cells back to patients, the researchers treated the patients with chemotherapy to deplete most of their existing immune cells; the new gene-edited cells were then able to populate and expand so that they eventually found and attacked the cancer cells they were designed to identify.
Why it’s important – While previous CRISPR-based strategies for cancer have involved removing genes in cancer cells that help them grow or that prevent the immune system from recognizing and attacking malignant cells, this approach introduces specific cancer-fighting immune cells that ultimately will help the patient avoid recurrences as well. The study wasn’t designed to test the effectiveness of the CRISPR therapy, so the results aren’t wholly indicative of the power of the therapy. But in this first trial, the treatment helped five of the 16 patients to stabilize their disease, so they did not progress, while 11 did not show benefit.
Implanted Magnets for Prosthetic Control
Medgadget’s Conn Hastings reports that engineers at MIT have developed a system that could let users of robotic prostheses more sensitively control their bionic limbs. The technology involves implanting pairs of small magnetic beads into muscles. When the muscles contract, the beads move closer together, allowing prosthetic devices to more precisely calculate a user’s intentions and mirror these. This latest development seeks to improve how robotic prostheses can sense their user’s intentions and move accordingly. At present, such devices typically sense the electrical activity of the muscles using a process called known as surface electromyography. However, this approach does not account for muscle activity in terms of velocity of movement and muscle length during contraction.
To address this limitation, the MIT researchers hit on a new approach called magnetomicrometry. This involves simple pairs of implanted magnetic beads that move together as a muscle contracts and further away from each other as it relaxes. The idea is to empower robotic prostheses to detect the magnetic signal from the muscle and infer the user’s intentions.
Why its important – While this may sound great in practice, and the researchers have shown that it works under controlled conditions in the lab, it is important to test technologies in a real-world context. the system was very useful in assessing muscle length, and could provide a measurement in less than a millisecond. Moreover, it compared favorably with more traditional equipment in terms of accuracy. The researchers also investigated the effects of the beads on the body, and found that they do not cause irritation in the muscle, suggesting that they are suitable for long-term implantation.