FDA authorizes digital Ebola test for emergency use, data on Omada's diabetes prevention program, and more digital health news briefs

Also: L’Oréal unveils UV sensor clip, companion app; Urinary incontinence wearable receives De Novo clearance.
By Dave Muoio
04:19 pm

De Novo clearance for urinary incontinence wearable. The FDA has granted De Novo clearance to Atlantic Therapeutics’ Innovo therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence. The wearable is intended for adult women as a front-line or second-line therapy, and in a multi-center randomized controlled trial recorded an 87 percent rate of dry or mild incontinence after 12 weeks of use.

“For the first time, physicians in the US can offer their patients a safe, clinically effective, non-invasive home-based treatment,” Steve Atkinson, CEO of Atlantic Therapeutics, said in a statement. “Innovo therapy is a compelling treatment option for all those women who today simply suffer in silence from stress urinary incontinence.”

Omada’s DPP assists underserved users. A clinical study gauging the effectiveness of Omada’s Digital Diabetes Prevention Program among 230 underserved individuals found that use of the tool led to a greater than 4 percent weight reduction among participants. Conducted by University of Southern California researchers and presented at the American Public Health Association’s Annual Meeting, the data also revealed at least 5 percent weight lost among 40 percent of participants, and a 55 percent program completion rate. Participants were enrolled at three sites, with each receiving access to the program alongside enrollment assistance, coaching and an adapted curriculum.

“Since Omada’s early days, we’ve worked to develop a program that can adapt to the needs of any participant,” Omada CEO Sean Duffy said in a statement. “That means being able to help individuals manage multiple disease states, and it means being able to deliver our program effectively to those in the most challenging circumstances. The study results presented today demonstrate we’ve done exactly that.”

FDA greenlights digital Ebola test for emergency use. Last week the FDA issued an emergency use authorization (EUA) for the DPP Ebola Antigen System, a rapid antigen fingerstick test that includes a battery-operated reader for easier reading. The system allows for tests to be conducted when providers do not have access to PCR testing, but is still indicated for use in appropriately equipped settings such as treatment centers or public health clinics.

“This EUA is part of the agency’s ongoing efforts to help mitigate potential, future threats by making medical products that have the potential to prevent, diagnosis or treat available as quickly as possible,” FDA Comissioner Dr. Scott Gottlieb said in a statement. “We’re committed to helping the people of the DRC effectively confront and end the current Ebola outbreak. By authorizing the first fingerstick test with a portable reader, we hope to better arm health care providers in the field to more quickly detect the virus in patients and improve patient outcomes.”

A light-powered UV sensor. L’Oréal has launched a UV sensor that clips onto the wearer’s clothing to track their exposure to UV radiation, Wired reports. Offered under its La Roche-Posay brand, the sensor pairs with a companion app that displays exposure and offers actionable tips to limit skin damage.

The sensor itself is roughly the size of a button, relies on sunlight for power and includes a near-field communication antenna to transfer data.

DrChrono’s new bundle. Mobile EHR company DrChrono today announced a new bundle for physical therapy and musculoskeletal providers. The bundle includes a smartphone, tablet and telemedicine consultation support, and along with EHRs is intended to help these providers manage their practice, medical billing and revenue cycle. In addition, customers will have access to Physitrack’s patient engagement platform, which can be accessed through the DrChrono provider app.

“We are very excited to offer an integrated physical therapy and outcome tracking program bundle in our EHR platform,” Daniel Kivatinos, cofounder and COO of DrChrono, said in a statement. “Out of office care treatments and patient outcome tracking are becoming more and more important, and DrChrono users can easily add this bundle program which includes a telemedicine solution to their line of care. This is a big win not only for physical therapists but other providers that use exercise treatments for care.”

University releases free brain game app. The University of Texas at Dallas’ Center for BrainHealth has released a free app that offers games designed to maintain and strengthen players’ cognitive abilities. The Brain Performance Challenge app’s challenges take approximately three minutes to complete, and the results are saved so that players can track themselves over time and compare their cognitive performance to those of others in their age group.

"The Challenge is intended to introduce key brain performance concepts in a fun way and informally measure your strategy, reasoning and innovation skills," Lara Ashmore, director of emerging technologies and online programs at the Center for BrainHealth, said in a statement. "Like everything we do at the Brain Performance Institute, the app is based on cognitive science and what we know about how the brain trains itself. We are very pleased that initial feedback from users has been overwhelmingly positive.”

AR app for endoscope cleaning. Index AR Solutions and Riverside Health System are working together on an augmented reality app to guide medical technicians as they clean endoscopes for reuse, the two announced yesterday. The app will use the technology to display step by step instructions and imagery directly over the actual device, and will also include safety warnings, short videos and written instructions within the app.

“While Riverside Health System has not experienced issues related to the cleaning and reprocessing of reusable endoscope devices, this is an issue that has caught the attention of the medical community, the public and the press,” Dr. James Lesnick, a neurosurgeon and current SVP for Business and Venture Development at Riverside Health System, said in a statement. “As medical practitioners, it is our responsibility to always look for ways to improve patient care and here, with Index AR Solutions, we believe we have found a way to bring the power of AR technology to bear in hospitals across the U.S. to benefit patients and technicians alike.”


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