NEW ORLEANS – Profusa, which creates bioengineered sensors, has developed an in-body sensor capable of continuous, long-term monitoring of body chemistry and streaming the data to a mobile phone and the cloud for personal and medical use. “Based on our ongoing studies, tissue-integrated sensor technology has the potential to enable wearables to live up to the promise of personalized medicine, revolutionizing the management of health in wellness and disease,” said Natalie Wisniewski, chief technology officer and co-founder of Profusa, in a statement. The Profusa researchers are developing a family of tiny biosensors composed of a tissue-like hydrogel that are placed under the skin with a single injection. They work fully integrated within the body’s tissue—without any metal device or electronics—overcoming the body’s attempts to reject it. To date, the injected biosensors have functioned for as long as four years. The Lumee Oxygen Platform, the first medical application of the biosensor technology, was approved for sale last year in Europe, and is helping wound-healing specialists track oxygen in the lower extremities of patients undergoing treatment for chronic limb ischemia. In addition to measuring oxygen, the Profusa team is developing biosensors for continuous monitoring of glucose, lactate, carbon dioxide and other molecules.
SAN DIEGO – The U.S. Food and Drug Administration has granted approval for DexCom’s G6 continuous glucose monitoring system for people with diabetes. The system was granted a De Novo request for use as both a standalone CGM and for integration into automated insulin dosing systems. Along with this authorization, the FDA is establishing special controls that outline requirements for assuring CGM accuracy, reliability and clinical relevance, as well as describe the type of studies and data required to demonstrate acceptable CGM performance. “The FDA’s special controls set a rigorous new standard in our industry and clearly define the process by which other CGM systems may be approved,” said Kevin Sayer, CEO ofcDexcom, in a statement. “We believe the new Dexcom G6 is a significant step forward for our industry.” The Dexcom G6 has new features, including: no fingersticks; easy sensor applicator; low profile; acetaminophen blocking; 10-day sensor; and predictive hypoglycemia alert. Dexom plans to launch the system later this year.
HOUSTON – The National Science Foundation has awarded $10 million to a Rice University-led team that hopes to create wearable and point-of-care microscopes that use on-chip illumination and sensing to non-invasively aid in the diagnosis and monitoring of nearly 100 health conditions that today require a biopsy or blood test. “The project will produce a platform technology for in vivo, 3-D tissue imaging, with the aim of being able to point a camera to a part of the body and see live biology below the skin without making an incision or drawing blood,” said Ashutosh Sabharwal, the principal investigator on the grant, in a statement. The five-year grant is one of three awarded from the National Science Foundation’s Expeditions in Computing program. Sabharwal’s team will use a combination of mathematical algorithms, camera design and imaging sensors to reverse engineer the path of scattered light. “Imagine a wearable device no larger than a watch that uses sensors to continuously measure white blood cell count and wirelessly communicate with the oncologist’s office,” Sabharwal said. “The patient could go about their daily life and only have to go to the hospital if there was a problem.”
REDWOOD CITY, Calif. – Biotricity has made its Bioflux mobile cardiac telemetry solution commercially available. The device’s technology is designed to support the diagnosis of cardiac arrhythmias, enhance patient outcomes and help reduce health care costs. “Bioflux was built for cardiac patients who require active monitoring because, until now, short-term monitoring or admission into the hospital for long-term observation was the standard,” said Waqaas Al-Siddiq, founder and CEO of Biotricity, in a statement. “Our technology addresses the multibillion-dollar cardiac-monitoring market in an innovative way.” The Bioflux system consists of the Bioflux device, software and a 24/7 monitoring center that merges with physicians’ existing platforms and workflows. The device monitors a patient’s electrocardiogram in near real-time, constantly analyzing and collecting data on the device and periodically uploading to the cloud via embedded cellular technology. Both symptomatic and asymptomatic patient symptoms are reviewed and triaged for each patient throughout the monitoring period.
STORRS, Conn. – Engineers at the University of Connecticut have developed a biodegradable pressure sensor that could help doctors monitor chronic lung disease, swelling of the brain and other medical conditions before dissolving harmlessly in a patient’s body. The research was reported in a recent issue of Proceedings of the National Academy of Sciences. The small flexible sensor has been approved by the U.S. Food and Drug Administration for use in surgical sutures, bone grafts and medical implants and was designed to replace existing implantable pressure sensors that have potentially toxic components and must be removed after use. The researchers said other potential applications include monitoring patients with heart disease, bladder cancer and glaucoma. “We knew that if we could develop a sensor that didn’t require surgery to take it out, that would be really significant,” said Thanh Duc Nguyen, the paper’s senior author. The new sensor is capable of capturing a wide range of physiological pressures, such as those found in the brain, behind the eye and in the abdomen, and can be used in its current form to help patients avoid invasive sensor-removal surgery.
BOSTON – Vital USA has teamed up with Partners Connected Health Care on a clinical trial to validate Vital’s 5-in-1 integrated vital sign monitoring platform. Paired with a smartphone, the Vital Moto Mod platform works with the Vital app to measure, monitor and track heart rate, respiratory rate, oxygen saturation, non-contact core body temperature and blood pressure, all within three minutes. “We have learned that frictionless technologies for biometric data collection from patients is key in fostering their engagement with digital products,” said Dr. Kamal Jethwani, senior director at Partners Connected Health Innovation, in a statement. “This product streamlines the vitals measurement process, replacing five discreet devices with one, and we are going to validate that this product is changing digital vitals collection from patients.” Using light and pressure sensors, Vital’s proprietary finger cuff measures systolic and diastolic blood pressure from the finger. The system captures user data wirelessly and uploads the data via Bluetooth to the cloud securely. “This is really the next frontier for personal wellness,” said Dr. Mark Blatt, chief medical officer at Vital USA, in a statement. “By providing the consumer with a simple way to measure and monitor the five critical vital health signs, they are empowered to take control, and keep an eye on their own overall health and wellness.”
SAN DIEGO, Calif. – toSense has received a second clearance from the U.S. Food and Drug Administration for the CoVa wearable patient-monitoring system for patients with congestive heart failure, chronic illness and those who have been recently discharged from the hospital. “CoVa is transformational in delivering high-acuity monitoring outside of the hospital,” said Matt Banet, president and chief scientific officer of toSense, in a statement. “The system gives clinicians remote access to important, actionable data.” Worn like a conventional necklace for just minutes each day, CoVa 2 measures bioimpedance and ECG waveforms, and calculates vital signs and hemodynamic parameters.
ITHACA, NY – Scientists at Cornell University have developed a method for gathering vital signs with “tag” devices that use radar-like technology.
“If this is an emergency room, everybody that comes in can wear these tags or can simply put tags in their front pockets, and everybody’s vital signs can be monitored at the same time,” said Edwin Kan, who developed the tag system, in a statement. “I’ll know exactly which person each of the vital signs belongs to.”
The system of radio-frequency signals and microchip tags can gather blood pressure, heart rate and breath rate by emitting radio waves that bounce off the body and internal organs and are then detected by an electronic reader that gathers the data from a location elsewhere in the room.
Kan said the system works like radar but integrates near-field coherent sensing, which is better at directing electromagnetic signals into body tissue, allowing the tags to measure internal body movement such as a heart as it beats or blood as it pulses under skin. Because each tag has a unique identification code it transmits with its signal, up to 200 people can be monitored simultaneously using just one central reader.
The signal is as accurate as an electrocardiogram or a blood-pressure cuff and could also be used to measure bowel movement, eye movement and other internal mechanical motions produced by the body, Kan said.
Kan’s research team is also working with Cornell’s Department of Fiber Science and Apparel Design, who have demonstrated a way to embroider the tags directly onto clothing using fibers coated with nanoparticles.
STANFORD, Calif. – A network of sensors, screens and smart devices being developed at labs around the world will extend the reach of caregivers and enable more people to manage their health at home, according to a researcher from Stanford University.
“We see this ecosystem as enabling a doctor to have continuous monitoring of a patient,” said Bryant Chu, a member of the design group in Stanford’s mechanical engineering department, where research is being done on the components that make up the bodyNET system, a four-layer ecosystem of components that includes devices and sensors that are implantable, dermal, incorporated into clothing and worn externally.
The bodyNET system’s core technology is made of electronics that can stretch and feel more like the human touch and can enable health professionals to see how a patient is feeling in real-time. The “elastronics” technology allows patients to interact with digitally networked devices and makes raw data from wearable devices more useful, Chu said.
While the idea of the bodyNET system may seem far-reaching, Chu thinks it’s something that could be a reality within the next 20 years. Before that happens, though, testing of the separate components will need to happen in controlled settings and industry concerns about privacy and security will need to be allayed, he said.
“We see a system like bodyNET as humanizing the technology rather than technology replacing us,” Chu said. “The idea of humans and technology coming together can be scary, but with a slight reframe of perspective, there’s an excitement about what could exist.”
HOUMA, La. – Objective Medical Systems has launched a cloud platform that allows real-time monitoring of patients with chronic cardiac conditions. “This advanced technology gives physicians a way to manage fragile patients with chronic diseases like heart failure stay healthy and reduce hospital admissions,” said Joseph Brunet, vice president of clinical affairs at OMS, in a statement. The OMS-3 platform aggregates patient data across digital remote monitoring devices, labs, electronic health records and cardiovascular diagnostic reporting modalities. It also features a cardiology-practice-specific user interface design, which presents data relevant to the diseases being managed, and incorporates video and text. “Physicians get notified if patients are trending toward an unfavorable outcome based on clinical variables which are remotely acquired in addition to a real-time remote interview with the patient,” said Dr. Vinod Nair, president and chief software architect of OMS. “This platform becomes a force multiplier in delivering higher quality patient outcomes.”