What happened in health care technology this week, and why it’s important.
This week’s post should probably be subtitled “the sensor edition,” with six articles featured about the continued development of sensor technologies to monitor numerous conditions in real-time and at the point of the patient. I’ve written extensively on remote patient monitoring in health care. But the market continues to evolve, and new types of sensors, combined with AI and Machine Learning, have expanded the clinical applications and accuracy of sensor technology and lowered the overall costs of deploying it. Read on to learn more.
Rockley Photonics books commercial rollout of biosensing wristband with mystery customer
Andrea Park in Fierce Biotech begins the coverage this week with her article on Rockley Photonics. The L.A.-area company and longtime Apple partner boasts a system confined entirely to a slim wristband, offering the standard continuous measurements of heart rate, respiratory rate, and blood oxygen levels, as well as body temperature, blood pressure, hydration, and—in its “Pro” iteration—blood alcohol content, blood lactate and glucose levels. The “Baseline” version of Rockley’s Bioptx wristband could be on consumers’ wrists as soon as the end of this year, the company said Tuesday, now that it has received the first commercial purchase order for the devices. The company says its customers can tailor the Bioptx band to their specifications by adding or subtracting specific biomarker tracking tools and optimizing battery life and overall performance.
Why it’s important – The FDA hasn’t yet authorized Rockley’s Bioptx technology. Still, the company plans to work with its partners and customers to lock down regulatory clearances in the U.S. and beyond. The next iteration of the Apple Watch—its eighth-generation model, expected to make its debut in September—would finally be the one to include a body temperature sensor, allowing the wearable to alert users to a potential fever. However, even if that new feature is coming courtesy of Rockley’s technology, Apple doesn’t seem likely to launch all of the Bioptx sensors at once since Power On’s Mark Gurman previously reported that the Apple Watch likely won’t include a blood pressure monitor until at least 2024, with glucose monitoring falling even further down the line. So, although it will be some time before all of these sensors will come to market, the developments show that real-time measurements at the point of the patient continue to grow.
Infographic of the week – Dr. Bertalan Mesko and his team at The Medical Futurist Institute released this infographic contrasting the key features of E-Patients and E-Physicians. I think the six “E”s concept is a great way to frame the conversation.
Bioengineered cornea can restore sight to the blind and visually impaired
Scientists from Linkoping University posted this article on NewsWise. Researchers and entrepreneurs have developed an implant made of collagen protein from pig’s skin, which resembles the human cornea. In a pilot study, the implant restored vision to 20 people with diseased corneas, most of whom were blind before receiving the implant. The study jointly led by researchers at Linköping University (LiU) and LinkoCare Life Sciences AB has been published in Nature Biotechnology.
Why it’s important – The promising results bring hope to those with corneal blindness and low vision by providing a bioengineered implant as an alternative to the transplantation of donated human corneas, which are scarce in countries where the need for them is greatest. An estimated 12.7 million people worldwide are blind because their corneas, the outermost transparent layer of the eye, is damaged or diseased. Their only way of regaining vision is to receive a transplanted cornea from a human donor. But just one in 70 patients gets a cornea transplant. Furthermore, most of those who need cornea transplants live in low and middle-income countries in which access to treatments is minimal.
The world’s first needle-free diabetes test
Freethink’s Kristen Houser reports that Australian researchers have developed a needle-free diabetes test that measures glucose levels from saliva — not blood. It could be ready for consumers as soon as 2023. Researchers at the University of Newcastle have developed a pain-free alternative to the finger-prick diabetes test. It’s a thin sensor about the size of a stick of gum. When a person licks the sensor, a coating on it interacts with their saliva. That reaction creates an electrical current that can be measured to reveal their body’s glucose levels on a smartphone app. They plan to begin construction on a dedicated manufacturing facility before the end of 2022, intending to produce devices by 2023.
Why it’s important – An estimated 30% of people with diabetes experience anxiety over the finger-prick process. That anxiety has been connected to testing avoidance — and if people aren’t testing their blood glucose levels when they should be, they might not be properly managing their disease. If this device makes it to the market, it would be a game-changer in the management of diabetes care around the world.
This Smart Necklace Soaks Up Your Sweat to Track Health
Engineers at The Ohio State University and the University of Wisconsin-Madison have developed battery-free sweat sensors that can measure several chemicals and give accurate readouts at various concentrations. Their sensors can be worn like a necklace or even implanted into the skin, where they would work throughout a user’s lifetime. Their research was reported by Maddie Bender in The Daily Beast online. Sweat biosensors are not a new idea for noninvasive monitoring, but most designs are bulky and require batteries that limit their lifespan. In the new study published on July 6 in Science Advances, the researchers combined typical biosensor design with electrical engineering principles to develop their sensors, which work the same way radios tuning into channels do. They then tested how well their flexible biosensors could measure dissolved potassium, calcium, sodium, and hydrogen ions at concentrations typically found in human sweat. Dropped into solutions of sodium, potassium, and hydrogen ions, a calibrated system of sensors measured the concentrations of each with between 97.5 and 98.9 percent accuracy.
Why it’s important – Unlike wearables that can only measure electrical currents at the skin’s surface (think FitBits and Apple Watches), a sweat-based biosensor could track the concentrations of electrolytes and sugar in the bloodstream and alert the wearer when their levels drop too low.
Patient with cancer receives first 3D-printed titanium jaw
A patient with head and neck cancer received the first 3D-printed titanium lower jaw in a successful operation, according to an August 4 press release from the Netherlands Cancer Institute (NCI). The jaw was reconstructed based on the patient’s imaging. Aunt Minnie’s Alex Dagostino reported that following four years of research led by head and neck surgeons from the NCI and Dutch 3D printing developer Mobius 3D Technologies, the new type of 3D-printed mandible was created from MRI and CT scans.
Why it’s important – Tumors in and surrounding the lower jaw are commonly treated by removing part of the mandible. If possible, the mandible is reconstructed using bone from elsewhere in the patient’s body. These reconstructive operations are complex, requiring vascular anastomosis and potentially causing morbidity at the donor site. Mandible reconstruction using metal plates poses other concerns as well. According to the NCI, in about 40% of cases, the plates extrude through the mucosa or skin, and the screws come loose, which has considerable consequences for the patient. The new jaw is designed to be the same shape and weight as the original bone and is stronger than the metal plates typically used in jaw replacement surgeries. It also features an improved fastening technique, making the implant much stronger, as the forces are better distributed, according to the NCI.
Bodyport receives FDA 510(k) for connected scale
Emily Olsen from MobiHealthNews brings us this story about Bodyport’s Cardiac Scale, which monitors patients with fluid management conditions like heart failure and kidney disease. The Cardiac Scale, intended for people 21 and over who weigh less than 397 pounds, can be used to track body weight, pulse rate, the center of pressure, and peripheral impedance, which can signal changes in fluid retention. Bodyport is pitching the scale as a way for care teams to monitor fluid status changes noninvasively and intervene before higher level care is needed. More than ten hospitals and health systems in the U.S. have used the tool in Bodyport’s research, according to the company, and it plans to release the scale more broadly later this year.
Why it’s important – The Bodyport Cardiac Scale could be a significant step forward in the standard of care for the remote management of patients with cardiorenal conditions. By providing a longitudinal view of fluid status, care teams can more effectively manage their patients through simple, optimized lifestyle and medication adjustments.
Mawi launches a patch to track heart health faster and in real-time
Tech Crunch’s Haji Jan Kamps reports that the company just released its product, a two-lead cardiac monitor that can be read in real-time. There are consumer-grade products that can do EKG readings, including the Withings ScanWatch (and its fancier-looking sibling, the ScanWatch Horizon). There are other patches on the market, such as the Zio patch, but Mawi claims to have done something unique and suggests that its Heart Patch is the first ever single-use, two-lead cardiac monitor to reach the market. The company describes it as “a stick-and-go, wireless solution” and further suggests that the disposable nature of the device is a benefit; it means that cardiologists can run tests on as many patients as they need to without having to wait for reusable Holter monitors to come back from other patients and get sanitized and maintained between uses. The devices need to be prescribed by a doctor, and pricing heavily depends on whatever medical insurance and what medical care system you are operating on, but the company says that the devices typically cost “under $250 per study.”
Why it’s important – Existing solutions are prone to dislodging, peeling, and causing allergic reactions, thus restricting monitoring time. Mawi Heart Patch, the company claims, can be applied in under a minute, and you can live like normal as you wear it. Patients can shower, sleep, work out,” and the company highlights that it’s possible to wear the patch and live all aspects of life as usual.
Sleep Monitoring at Home: Interview with Ziv Peremen, CEO of X-trodes
Finally, this week here’s an interview that Conn Hastings from Medgadget conducted with Ziv Peremen, the CEO of X-trodes, on their development of Smart Skin, wireless monitoring, and analytics technology suitable for at-home sleep monitoring. Smart Skin can detect a wide array of sleep disorders, including sleep apnea, narcolepsy, bruxism, restless leg syndrome, and insomnia. The wearable electrodes can also obtain an array of data, including EEG, EOG, EMG, and ECG/EKG tracings. The patient receives the system at home and follows a brief explanatory video through the dedicated smartphone app to set up the system. The setup process takes just a few minutes, and the user does not need to wear the system or “break it in” just before use. It can be worn any time during the evening without disrupting one’s usual nighttime activities. The patient conducts a short calibration process and then simply goes to sleep, in their room and their bed, with all the common sleep conditions they are used to. In the morning, the patient needs only to press a synchronization button on the app, and the data collected overnight is uploaded directly to the cloud, which the physician can then access for sleep scoring and clinical evaluation.
Why it’s important – The current practice of measuring sleep based on a single timeframe within the confines of a clinic is a limiting factor for genuinely understanding our sleep. This usually provides only a partial insight into our sleep profile, the sleep disturbances, and their causes. By making sleep monitoring accessible at home, in our natural sleeping environment, and over multiple consecutive nights, we can optimize the potential of understanding our health. We can leverage a test intended to diagnose sleep disorders to learn more about sleep-related disorders. We can then monitor the progression of the sleep and sleep-related disorders and, through continuous monitoring, guide treatments and select the best treatments and doses. We hope that, soon, we will be able to harness vast amounts of sleep data to facilitate preventive strategies, learning about new disorders early enough to improve treatment and postpone the onset of complications.