What happened in health care technology this week, and why it’s important.
Rune Labs’ Apple Watch-based Parkinson’s disease tracker gets FDA clearance
Nicole Wetsman in The Verge reports that software that helps people with Parkinson’s disease track symptoms through their Apple Watch received clearance from the Food and Drug Administration, the company behind the tool announced today. It automatically tracks things like tremors, and it lets patients report symptoms and medication usage. Neurology company Rune Labs built the software called StrivePD. It lets clinicians track their patients’ progress and any changes in symptoms from the neurological disorder, which causes involuntary movements and difficulty with coordination.
Why it’s important – The passive data collection means patients’ don’t have to try and remember those fluctuations. It’s also a rich source of data on how Parkinson’s patients respond to various medications. The FDA sign-off means clinicians have ways to bill patients when reviewing data from the watch and lets the findings be used as clinical trial data on various Parkinson’s disease treatments.
Infographic of the week – a nice graphic compilation of digital health medication adherence companies by The Digital Apothecary.com
Ekso Bionics exoskeleton cleared for use with MS patients
In other FDA clearance news, Sean Whooley reports that EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use in patients with MS, significantly expanding the device’s use to a broader group of patients. The latest generation of the Ekso Bionics platform, the EksoNR, received clearance for stroke and spinal cord rehabilitation in 2016, then acquired brain injury (ABI) in 2020.
Why it’s important – EksoNR has the potential to assist significantly more patients and improve patient mobility.
Keeping Up to Date on SaMD Regulations
In the Mayo Clinic Platform blog, John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, outline how this kind of standalone software is having a significant impact on the delivery of medical care worldwide and when coupled with machine learning, has the potential to transform patient care in ways that were unimaginable a few years ago. They highlight the FDA’s new set of guidelines, Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD) Action Plan, the purpose of which is to accommodate the many iterations expected from these new digital tools as they respond to new data and adapt algorithms accordingly. And they provide an overview of the basics in understanding how Software as a Medical Device regulations will be used in health care.
Why it’s important – This is must-reading for health care executives and their teams to understand the new regulations and how the FDA will begin to expect real-world performance monitoring for artificial intelligence and machine learning-based software as a medical device.
3D PRINTED IMPLANTS ENABLE FACIAL DEFORMITY SURGERY SUCCESS
Haley Everett reports this milestone in an article in 3D Printing Industry online. Doctors in Dubai have successfully completed a series of surgeries on a young male patient to reform his facial deformities using 3D printed titanium implants. The surgery completely reconstructed the patient’s facial bones, which had been severely damaged from several benign tumors.
Why it’s important – The technology is being deployed to create biocompatible, patient-specific implants capable of facilitating bone cell growth and repairing structural deformities. Opting for the implants meant the patient did not have to undergo multiple soft and hard microvascular grafts from his abdomen and legs to reconstruct his facial bones, which would have seriously affected his quality of life.
Nanoparticle sensor can distinguish between viral and bacterial pneumonia
Anne Trafton at MIT reports that researchers have now designed a sensor that can distinguish between viral and bacterial pneumonia infections, which they hope will help doctors choose the appropriate treatment. They are currently developing versions for human use that could be administered using either a nebulizer or an inhaler similar to an asthma inhaler. They are also working on detecting the results using a breathalyzer instead of a urine test, which could give results even more quickly.
Why it’s important – Many different types of bacteria and viruses can cause pneumonia, but there is no easy way to determine which microbe is causing a particular patient’s illness. This uncertainty makes it harder for doctors to choose effective treatments because the antibiotics commonly used to treat bacterial pneumonia won’t help patients with viral pneumonia. In addition, limiting the use of antibiotics is an important step toward curbing antibiotic resistance. In designing their sensor, the research team focused on measuring the host’s response to infection rather than trying to detect the pathogen itself. Viral and bacterial infections provoke distinctive types of immune responses, including activating enzymes called proteases, which break down proteins. The MIT team found that the pattern of activity of those enzymes can serve as a signature of bacterial or viral infection.
CONSORTIUM UNVEILS GUIDELINES FOR USING DIGITAL TWIN TECHNOLOGY
Health Leaders Eric Wicklund reports that an organization called The Digital Twin Consortium has created a framework for the use of digital twin technology, which is just now being adopted in healthcare to help providers improve care management. Reality Capture: A Digital Twin Foundation lays out the groundwork for using the technology, which essentially uses sensors and AI to create a digital twin of an object, room, building, or landscape for use in planning and design. In healthcare, the strategy focuses on developing a digital twin of a patient, which can then be used to test the effectiveness of treatments before they’re tried on the patient.
Why it’s important – With its new document, the Digital Twin Consortium aims to lay the foundation for guidelines and standards of digital twin technology. The published white paper can provide information organizations can use to make the right investment decisions.
Scientists Develop “Nanomachines” That Can Penetrate and Kill Cancer Cells
A research team headed by Dr. Youngdo Jeong from the Center for Advanced Biomolecular Recognition at the Korea Institute of Science and Technology (KIST) has reported the development of a novel biochemical nanomachine that penetrates the cell membrane and kills the cell via the molecular movements of folding and unfolding in specific cellular environments, such as cancer cells.
Why it’s important – In the last couple of months, promising results have been published about nanomachines in a medical setting. How does it keep healthy cells intact? In normal cells with a relatively high pH, the movements of the nanomachines were restricted, and they could not penetrate the cell.
Carilion Clinic, TytoCare team up to expand rural telehealth
Katie Adams in MedCity News reports that Carilion Clinic, a health system based in Roanoke, Virginia, that has a sizable rural patient population announced a partnership with TytoCare, a New York City-based telehealth company. The partnership aims to strengthen the health system’s ability to diagnose and treat patients remotely with virtual physical exams using TytoCare smart devices, such as its telehealth exam kits and pop-up remote health clinic.
Why it’s important – With access to health care in rural areas declining, using telemedicine approaches to manage chronic care is even more critical today than in the past. Carilion uses TytoCare’s telehealth devices to monitor pediatric asthma patients remotely and care for rural patients with chronic conditions. The health system also will deploy the TytoClinic solution, which can turn any location into a remote telehealth clinic, in rural schools to increase students’ and teachers’ access to primary and specialty care.
How researchers are using old phones to screen for Alzheimer’s
The DigiHealth Lab at UC San Diego, directed by Professor Edward Wang, looks at ubiquitous technology like smartphones to figure out how they can be used to monitor our health. The idea is that, by building digital health tools that work on more common devices, they can increase access to more people — particularly people who might not be able to afford the latest smartwatch or fitness tech. Matt Morales featured this video in his article on The Verge.
Why it’s important – Great review of how the latest and greatest technology isn’t always required to monitor a person’s health. It also brings personal health monitoring to a broader population segment who might not be able to afford the latest smartphone.
Alimetry gets FDA clearance for wearable gut disorder test
Finally, this week, from Adam Ang in MobiHealthNews, we get this article on technology startup Alimetry, which has received clearance from the US Food and Drug Administration for its wearable device for diagnosing gastric disorders. Gastric Alimetry is a non-invasive test for common stomach disorders, including nausea and vomiting, gastroparesis, and functional dyspepsia. The Gastric Alimetry test is only performed in a clinical setting. Recordings are taken before and after a meal while patients simultaneously log their symptoms into a companion mobile app. The wearable device captures digestive patterns from the skin surface and then delivers clinical reports via the cloud, which ultimately informs the diagnosis of gastric diseases and supports personalized therapy.
Why it’s important – Existing gut tests are “frequently unreliable and inconclusive” with patients undergoing months or years of testing, which is often costly, invasive, and involves radiation. And the market for these is growing. Other wearable patches have been developed and marketed in the United States to track and identify gastrointestinal issues. In 2018, researchers from the University of California San Diego created a wearable device that can track electrical activity in the stomach over 24 hours. G-Tech Medical, also from California, has developed a wearable, disposable sensor patch for measuring electrical activity in the gastrointestinal tract.