Sixth time's the charm? Roche’s Accu-Chek Connect Diabetes Management App has notched its sixth device recall from the FDA, this time due to meter-to-app data transfer issues for users with Android OS 8.0 and above. According to the agency’s posting, Roche notified partners, users and call centers of the issue and released and update addressing the problem before the end of that month.
Prior to this, the last recall notification for the app came back in early 2018, and was the result of a bug that could lead users to self-administer inappropriate doses of insulin. In fact, this newest notification is that first that is not directly related to the app’s Bolus Advisor feature.
Alphabet scoops up former FDA commish. Obama-era FDA Commissioner Dr. Robert Califf will be stepping into Alphabet as its full-time head of strategy and policy for Verily Life Sciences and Google Health, according to a blog post announcement from Duke University, where he has been serving as director of its health data science center. Califf has held an advisory role for Verily since 2017, but will make the full transition to his new position at the beginning of November. He will also remain an adjunct professor for the school’s University of Medicine.
ResApp's early sleep apnea data. Brisbane, Australia-based respiratory health company ResApp has announced top-line results from its prospective study on obstructive sleep apnea (OSA).
From a sample of 238 patients with analyzable data, the study found the app’s algorithms to identify OSA cases on par with a simultaneous full, unattended polysomnography. Sensitivity and specificity rates for mild, moderate and severe OSA incidences were 85% and 73%, 83% and 80%, and 83% and 90%, respectively.
“By delivering a highly scalable, low cost smartphone app for OSA screening we have a huge opportunity to reduce the health and economic impact of undiagnosed OSA," ResApp CEO and Managing Director Tony Keating said in a statement. “We will now move forward into the regulatory submission and commercialization phases of this exciting project.”
Consumer telemedicine plants its roots. Hims, a direct-to-consumer telemedicine and mail-order medication company, announced plans to open a pharmacy operation in the Columbus, Ohio area. The new infrastructure will now allow the company to handle its order fulfillments in-house and, according to Hims, better ensure medication dispensation safety. This facility will also serve as a customer support center, and is set to establish more jobs in the region.
“At Hims, we want to make it easier for everyone to get the care they need,” Andrew Dudum, CEO and founder of Hims, said in a statement. “The Columbus Region provides direct access to our customers throughout the US – including those in rural areas who may live an hour or more from an open pharmacy – as well as an impressive pool of talent. We’re excited to invest in the area as we work to expand access to affordable, quality healthcare for everybody.”
Connected neurostimulation system cleared. The FDA has approved Abbott’s Proclaim XR, an app-connected neurostimulation system for chronic pain. The product delivers lower energy electrical pulses of spinal cord stimulation, an approach that, according to the company, allows the system a lifetime of 10 years before running out of power.
"For the 50 million people living with chronic pain in the United States this is a new and exciting treatment that is supported with evidence validated by the BOLD study, an established protocol for titrated intermittent dosing to give patients individualized pain relief while using therapy for 6 hours or less per day,” Dr. Timothy Deer, president and CEO of The Spine and Nerve Center of the Virginias in West Virginia, said in a statement provided by Abbott. "Proclaim XR is a major advancement in spinal cord stimulation, and is an evidence-based therapy that is mobile app-based and features upgradeable software. This means patients won't need surgery to benefit from future advances in this technology.”
Looking to pharma. VivaLNK, the company best known for its remote patient monitoring ECG patch, has announced that its products are now open to the pharmaceutical market. The company said its remote patient monitoring wearables can now be used for clinical trials. The company’s patches can capture ECG trace, heart rate, respiratory rate, temperature, three-axis motion, heart rate variabilty-derived stress and recovery, and sleep quality.
“The next evolution of clinical trials is to obtain quality data over a continuous period of time in order to truly assess the implications on a patient’s physiology,” Jiang Li, CEO of VivaLNK, said in a statement. “Without continuomics, we only get snapshots of data in time, which can significantly limit the knowledge and success of research and development.”