PHILADELPHIA – A wireless device was as accurate as traditional echocardiography and CMR imaging in detecting heart dysfunction in childhood cancer survivors, according to a study published recently in Clinical Cancer Research. The Vivio device, developed by Avicena, is a prototype handheld instrument that collects pulse waves and phonocardiogram data from the carotid artery. The data is then streamed wirelessly to a compatible device such as a smart phone or e-tablet. The mobile health platform eliminates the need for result interpretation and allows for real-time monitoring of heart health, the researchers wrote in the study. “This study is the first step in thinking about new paradigms of long-term monitoring and care delivery for cancer survivors who are at risk for severe and life-threatening health conditions,” said researcher Saro Armenian, director of the Childhood Cancer Survivorship Clinic, City of Hope, Duarte, Calif., in a statement. Anthracycline chemotherapy can cause heart failure in young cancer patients, so they are commonly
INDIANAPOLIS – Roche Diagnostics has launched the CoaguChek Vantus system, a self-testing device for coagulation monitoring with Bluetooth technology. Using the system, patients can use their tablet or smartphone with a compatible app to send their results automatically to their provider via wireless connectivity. “As health care systems face continued pressure to deliver improved access to care at a lower cost, increased connectivity between health care providers and patients becomes even more important,” said Dr. Alan Wright, chief medical officer at Roche Diagnostics, in a statement. “This innovative technology sets the standard in coagulation monitoring by providing high quality, convenient testing, while optimizing the patient result reporting workflow. The CoaguChek Vantus system also features medication and testing reminders, the ability to flag results in relation to the target range and the option to insert comments to the result. The hand-held device enables patients to conveniently monitor international normalized ratio (INR) results with an intuitive user-interface, while enabling flexible remote connectivity to their health care providers through Bluetooth technology. Trend report functionality also provides both patients and their health care providers with an overview on the stability of their anticoagulation levels.
ALLENDALE, Mich. – A group of engineering students from Grand Valley State University partnered with Beaumont Health to create a medical device that has the potential to improve the quality of life for people with neuromuscular diseases. The cough assist device was created to help clear the airway of individuals with diseases such as muscular dystrophy and cystic fibrosis. The device is patent pending and was recently licensed to be commercially manufactured in China, making it the first commercial licensing agreement for Grand Valley’s engineering program. “We designed the device to be used for people of all ages who have pulmonary problems,” said Jake Stephens, one of four students who designed and built the device, in a statement. The device is portable, lightweight and made out of plastic and vinyl. It includes a tube attached to a face mask and two valves to control air pressure and volume. It requires no electricity to operate. The Beaumont Commercialization Center negotiated a license with TechBank Medical, a Shanghai-based medical commercialization organization. “For developed markets like the U.S., this technology will provide a truly portable device that is small, lightweight and does not require electrical power,” said Brad Yang, CEO and founder of TechBank Medical, in a statement. “For developing markets, like China and India, the design allows for those previously unable to afford a cough assist device to finally get relief from their disease, as the technology has a simple and low cost design.”
MEXICO CITY – Mexico is updating its medical device classification process, allowing the deregulation of more than 2,000 products considered low risk. The country’s Federal Commission for Protection against Sanitary Risks (COFEPRIS) said that by deregulating the lower-risk devices, it will be able to focus on enabling earlier access for innovative devices. The announcement marks the third deregulatory listing for medical devices, following the deregulation of 1,669 in the first stage and 573 in the second stage, according to BMI Research. The revised device classification is a move toward harmonization with international standards. Mexico is the leading exporter of medical devices in Latin America, and it ranks eighth internationally, according to COFEPRIS.
HERNDON, Va. – Iron Bow Technologies, an information technology solutions provider to health care, government and commercial markets, has been selected as a 2017 Innovation Award honoree for its clinical care device by the Washington Business Journal. The CLINiC is a consultation device that enables remote care via live video conferencing. “This recognition is validation that our efforts are making a difference in the delivery of care,” said Scott Sanner, general manager of Iron Bow Healthcare Solutions, in a statement. “It’s an exciting time to be involved in the advancement of transformational health care delivery and making a difference in the lives of individuals.” In addition to the CLINiC device, Iron Bow last year introduced the MEDiC mobile exam device and ViTAL, an intuitive, portable telehealth device designed to facilitate vital readings from a non-medical user to a licensed care provider.
‘We really need to be exactly what people want’
AUSTIN, Texas – It’s been a long road to market for UnaliWear, maker of the Kanega voice-controlled watch, but the light at the end of the tunnel is getting brighter as the company looks to launch the device in 2017.
“We hope to be in production in the fourth quarter this year,” said JeanAnne Booth, CEO and founder of UnaliWear.
A $100,000 Kickstarter campaign launched in 2015 originally called for the device to be available last year, but Booth wanted to be sure the Kanega was something users needed, so adjustments to the timeline were made along the way.
“We really need to be exactly what people want,” she said.
The Kanega watch is a voice-controlled device that features fall detection, medication reminders, emergency assistance, voice-activated directions and Guide Me Home assistance if the user gets lost. The waterproof device works independently of a home-based system or smartphone and has no buttons to push.
The watch uses artificial intelligence to learn the wearer’s lifestyle, and that information is updated each night.
The company has spent the past five months deep into a user experience test on the latest version of the device. Users included about 100 people across the country ages 23 to 97 with Multiple Sclerosis, Lou Gherig’s disease, Parkinson’s disease, epilepsy, Down’s Syndrome, blindness, disabled veterans and seniors.
Booth said the user experience test was invaluable to the company, as it brought to light some issues only a user would experience like battery charging and instruction language.
“The user experience test was fantastic—we knew it was the right thing to do,” she said.
Booth said UnaliWear will look to add biometrics to the Kanega device in the future.
“We want to wait on the biometrics until we have enough money to get through the U.S. Food and Drug Administration process independently, without having to rely on investors,” she said.
The company is continuing with a smaller user experience test on the final production version over the coming weeks.
‘Organizations need to start carefully examining what they’re doing’
MOUNTAIN VIEW, Calif. – Medical device makers and health care providers are unprepared for possible cyberattacks, according to a study released recently by security company Synopsys.
“This report doesn’t paint a good picture at all for the industry,” said Mike Ahmadi, director of critical systems security, software integrity group, at Synopsys.
Despite the likelihood of an attack, only 17% of device makers and 15% of health care providers are taking significant steps to prevent attacks, the report found.
More specifically, the report found that 67% of device makers believe an attack on one or more of their devices is likely and 56% of health care providers believe such an attack is likely. Further, only 22% of health care providers say they have an incident response plan in place in the event of an attack and 41% of device makers say they have such a plan in place.
Ahmadi said there is a lot of regulation from the U.S. Food and Drug Administration to bring a medical device to market, but security is not a big part of the process.
“Once the device is at market, it’s even less so,” he said. “And devices become less secure over time.”
In fact, the report found that more than half of health care providers do not test medical devices for security issues or are unsure if testing occurs at all. More than 40% of device makers do not test the devices they have released to find new or previously unidentified vulnerabilities.
Ahmadi said the problem is the lack of bite from the FDA. He believes the most effective way to get companies and health care providers on board with medical device security is through incentives, not punishments or fines.
“We need to move from FDA guidance to solid, enforced requirements,” he said. “It’s absolutely critical.”
Ahmadi said the FDA has taken notice of the Synopsys report and has invited his team to come in and talk about how to address the problems the report found.
“It’s clear the game has changed pretty quickly,” said Ahmadi. “Organizations need to start carefully examining what they’re doing in terms of medical device security.”
LONDON – The United Kingdom’s National Institute for Health and Care Excellence is launching a fee-based online tool to help health device makers get their products to market faster. The Medtech Early Technical Assessment (META) tool will help companies identify what evidence they already have and what gaps need to be filled to satisfy payers. The new tool will help developers of medical devices and diagnostics generate evidence to show their products are clinically relevant and cost effective. The tool will enable companies to better articulate the benefits of their products, and will help companies prepare for a dialog with health technology assessment organizations and payers, said Leeza Osipenko, head of NICE Scientific Advice, the institute’s fee-based consultancy service, in a statement. She said META is aimed primarily at small- and medium-sized companies.
EDEN PRAIRIE, Minn. – Reminder Rosie, a device designed to remind people with memory loss to take their medication and complete daily tasks, achieved 80% compliance for 86% of patients in a recent pilot study conduced by the Toronto Central Community Access Centre. The three-month study of 11 patients found the device to be especially helpful for those with mild dementia and cognitive impairment, and projected cost savings for home care professionals between $3,000 to $6,000 annually. Manufactured by LifeAssist Technologies, Reminder Rosie allows caregivers to record up to 25 personalized messages in any language.
ARLINGTON, Va. – Personal health analytics company Zansors has secured a patent from the U.S. Patent and Trademark Office for a wireless electrocardiogram (ECG) acquisition and monitoring device. The patent will allow heart-monitoring devices to be integrated into clothing, or secured directly onto the skin. “Focusing on a patient-friendly experience with wearables has led directly to this patent,” said Nicole Stout, vice president of medical affairs at Zansors, in a statement. The company announced in March that it received its first utility patent for a wearable patch comprising multiple separable adhesive layers for to combining electronics and health monitoring.