Dexcom G6 receives FDA approval
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.
Merck, Medisafe partner on medication adherence solution
DARMSTADT, Germany – Merck KGaA is collaborating with Medisafe on a customized version of Medisafe’s mobile medication adherence platform for cardiometabolic patients. Plans for the platform include reminders, motivation and support systems, targeted content, coupons and interventions in the user’s local language. “This is an extremely important step toward realizing our vision of supporting patients with comprehensive, integrated, value-added services that look beyond medicines to improve treatment outcomes,” said Simon Sturge, COO at Merck KGaA, in a statement. “We are confident that offering such a solution to our patients has the potential to significantly improve medication adherence by giving patients and caregivers the tools to organize, understand and manage their medications.” The new digital solution will complement Merck KGaA´s current offering of primary care medicines for cardiometabolic conditions, which includes treatments for Type 2 diabetes, thyroid disorders and cardiovascular diseases.
Intent Solutions names Kidd CTO
ATLANTA – Intent Solutions has named John Kidd as its new chief technology officer. Intent Solutions is the creator TAD, for “Take As Directed,” a smart, mobile medication dispenser that assists patients in obtaining better health outcomes by helping the right patient take the right dose at the right time. “Intent Solutions has a massive sea of opportunity,” said Kidd in a statement. “Providing technology solutions where we can extract and see commonalities, we will be able to find new product opportunities within this large market space not only moving forward with TAD, but possibly other products that fit our customer’s needs.” Kidd is a technology executive with experience that includes researching, developing and implementing technology solutions at multiple Fortune 100 companies.
VitalConnect launches continuous monitoring platform
SAN JOSE, Calif. – VitalConnect, a provider of wearable biosensor technology for wireless monitoring in hospitals and remote patient populations, has launched its Vista Solution platform. The technology enables wireless, real-time, continuous patient monitoring and delivers patient data for caregiver analysis. The new platform integrates the company’s existing VitalPatch wearable biosensor, which continuously measures eight biometrics in real-time. “The VitalPatch brings a light, wireless and comfortable solution to patient monitoring,” said Dr. Nersi Nazari, CEO and founder of VitalConnect, in a statement. “Now with our Vista Solution, caregivers will have continuous insight into their patients and can intervene when additional care is needed between spot checks.” In home care environments, remote and continuous monitoring have shown significant cost savings, fewer readmissions and improved rest for the patient, he said. The Vista Solution platform was piloted in collaboration with Mercy Virtual. It will be launched in Mercy Hospital St. Louis, and then deployed to additional hospitals and outpatient settings across Mercy facilities in four states in 2018.
Researchers develop tooth-mounted sensor to collect glucose data
MEDFORD/SOMERVILLE, Mass. – Researchers at Tufts University School of Engineering have developed miniaturized sensors that can be mounted on a tooth and communicate wirelessly with mobile health devices to transmit data on glucose, salt and alcohol intake. In research to be published soon in the journal Advanced Materials, the researchers said that future versions of the sensors could enable the detection and recording of a wide range of nutrients, chemicals and physiological states. “We have extended common radiofrequency ID technology to a sensor package that can dynamically read and transmit information on its environment, whether it is affixed to a tooth, to skin or any other surface,” wrote Fiorenzo Omenetto, an author of the research. The sensor has a 2mm x 2mm footprint that can flexibly conform and bond to the irregular surface of a tooth and is made up of a central “bioresponsive” layer that absorbs the nutrient or other chemicals to be detected, and outer layers consisting of two square-shaped gold rings. Together, the three layers act like a tiny antenna, collecting and transmitting waves in the radiofrequency spectrum.
Adherium’s sensor cleared for OTC
SAN MATEO, Calif. – The U.S. Food and Drug Administration has cleared Adherium’s Smartinhale sensor for over-the-counter sales. The sensor was cleared for use in AstraZeneca’s Symbicort aerosol inhaler to monitor and promote asthma and COPD medication adherence as part of a self-management plan. It automatically records the date and time the inhaler is used and sends the information to an app on the user’s smartphone or tablet. “Over-the-counter sales of our Smartinhaler sensor for the Symbicort aerosol inhaler continues the advancement of our vision for stronger partnerships between patients and physicians by making adherence to personal management plans easier,” said Arik Anderson, CEO of Adherium, in a statement. “We are now well positioned to launch in the U.S., following successes in Europe and Australia.” OTC clearance means that Adherium’s Smartinhaler can now be sold directly to consumers, including through pharmacies and online, without the need for the patient to first obtain a prescription.
DarioHealth glucose monitoring system now compatible with new iPhones
NEW YORK and CAESAREA, Israel – The U.S. Food and Drug Administration has cleared the Lightning-enabled version of DarioHealth’s blood glucose monitoring system for use with the Dario app on iPhone 7, 8 and X smart mobile devices. “The launch of Apple’s smartphones with only a Lightning connector posed a unique challenge to the entire mobile ecosystem,” said Erez Raphael, chairman and CEO of DarioHealth, in a statement. “This news opens a significant U.S. market opportunity for DarioHealth, as it enables us to provide our diabetes management platform and expand the sales of the Dario Blood Glucose Monitoring System. This continues DarioHealth’s U.S. market progress and truly opens the door for wide-scale expansion in this pivotal market.”
mHealth program increases screening, study finds
WINSTON-SALEM, N.C. – Use of a mobile app doubled the proportion of patients who were screened for colorectal cancer, according to a study conducted by researchers at Wake Forest School of Medicine and published recently in the Annals of Internal Medicine. The Mobile Patient Technology for Health–CRC app informs patients of the need for screening and gives them the ability to self-order tests. Study participants who interacted with mPATH-CRC viewed an 8.6-minute decision aid about screening and reviewed the two most commonly used tests, fecal testing for blood and colonoscopy. The app then let patients select their own screening test. Screening was completed by 30% of the mPATH-CRC participants, compared to 15% of those receiving usual care. More mPATH-CRC participants could state a screening preference, planned to be screened within six months, discussed screening with their provider and had a screening test ordered. Half of mPATH-CRC participants self-ordered a test through the app. “Two components of mPATH-CRC directly encourage screening orders: the decision aid, which increases patients’ intention to receive screening, and the ability to self-order tests, which decreases barriers to order entry,” said Dr. David Miller Jr., author of the study.
BioIQ raises $26.5M
ATLANTA – Health care technology company BioIQ has raised $26.5 million to continue its growth in the U.S. “BioIQ is committed to helping all people understand their health risks and connect to personalized interventions,” said Justin Bellante, CEO of BioIQ, in a statement. “Our intelligent technology fundamentally changes how individuals navigate the national health care system, resulting in greater convenience, improved access, higher quality outcomes and reduced costs.” The company’s technology platform provides tools for orchestrating health testing programs and biometric screening events across multiple vendors, as well as multi-channel communication tools for engaging and motivating participants at every step of the way. The company works with health plans, employers and health service providers, as well as a network of retail pharmacies, laboratories and accountable care organizations to facilitate consumer navigation and the secure exchange of health care data in an effort to close the gaps and improve preventative health testing.
Accolade raises $50M to grow workforce, technology
SEATTLE – Health care technology company Accolade has raised $50 million in funding to grow its workforce and expand its Personalized Advocacy solution. Accolade provides personalized health and benefits data to employers to help their employees find the right health care at the right time and reduce health care waste. “We are seeing tremendous momentum across all market segments,” said Rajeev Singh, CEO of Accolade, in a statement. “Self-insured employers are increasingly taking charge of their health and benefits supply chain and are looking to work with those that can help deliver personalized solutions for their employees and their families.” Over the past two years the company has more than tripled the size of its technology and product development team, and is investing in building a connected and flexible technology platform to complement its service and clinical offering. Recent technology platform developments include Accolade’s Maya intelligence engine with machine learning capabilities, an integrated health and benefits member portal, the Accolade Mobile app and the Accolade IQ customer analytics and reporting tool.
VA launches Video Connect
WASHINGTON – The U.S. Department of Veterans Affairs launched its new VA Video Connect application last week, connecting veterans with their health care team from anywhere, using encryption to ensure a secure and private session. The app makes VA health care more convenient and reduces travel times for veterans, especially those in very rural areas with limited access to VA health care facilities. It also allows health care access from any mobile or web-based device.
National Stroke Association, Ekso Bionics partner for stroke rehabilitation education
CENTENNIAL, Colo., and RICHMOND, Calif. – The National Stroke Association and Ekso Bionics have kicked off an educational partnership to increase awareness of and access to advanced stroke rehabilitation exoskeleton technology that enables earlier mobility and restored independence for survivors of stroke. The National Stroke Association is a nonprofit organization that provides stroke education and programs to stroke survivors, caregivers and the health care community. Ekso Bionics develops exoskeleton technology for medical and industry use, including the EksoG, an exoskeleton device approved by the U.S. Food and Drug Administration for stroke rehabilitation. “This campaign will supplement the reach of our current educational programs and resources for survivors and send out a message that better outcomes in stroke rehabilitation is possible through the use of an exoskeleton technology,” said Robyn Moore, CEO of the National Stroke Association, in a statement. “We endeavor to make exoskeleton technologies a part of the dialogue between survivors and their circle of care in regards to their goal to regain mobility and restored independence.”