FDA

By Laura Lovett January 22, 2018
Nokia has announced that it will disable the pulse wave velocity measurement feature on its Withings’ Body Cardio scale as of January 24. The company said it is now learning the technology may require a different level of regulatory approval. However, no specific regulation is cited and the company said the FDA did not recommend or request the removal.  “There was not a specific regulatory issue...
By Dave Muoio January 15, 2018
Last September, Tidepool — a diabetes data management platform — was among the nine companies chosen to participate in the FDA’s experimental pre-certification program pilot. Along with Apple, Samsung, Verily, Johnson & Johnson, and others, Tidepool would work with the agency to prove its overall development processes are responsible and safe, negating the need for product-by-product...
By Dave Muoio December 21, 2017
Beyond fielding an ever-increasing number of digital health clearances, the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape. The beginning of the year saw a new administration take the reins, and with it the nomination and appointment of a new commissioner, Dr. Scott Gottlieb. By the year’s end, the new guard already had announced...
By MobiHealthNews December 21, 2017
In 2017, MobiHealthNews covered 51 devices that received clearance from the FDA. Along with a handful of diagnostic devices, disease management platforms, and novel monitors, this year boasted a few surprises from the agency, such as the approval of a direct-to-consumer genetic tests for disease risk and a purely digital intervention. The year also hosted its fair share of regulatory news and...
By Dave Muoio December 8, 2017
Heads of the FDA’s Center for Devices and Radiological Health (CDRH) recently penned a blog post describing their previous and ongoing efforts with closed-loop artificial pancreas manufacturers to ensure proper testing and validation of the devices.  In it, Courtney Lias, director of the Division of Chemistry and Toxicology Devices at CDRH, and Stayce Beck, chief of the Diabetes Diagnostics...
By Jonah Comstock December 7, 2017
FDA Commissioner Scott Gottlieb dropped three new FDA guidance documents today, two draft guidances and a final guidance. One draft guidance is the long-awaited guidance on clinical (as well as patient) decision support, while the other deals with changes to medical software policy based on Congressional mandates in the 21st Century Cures Act. The final guidance is on Software as a Medical Device...
By Jonah Comstock December 7, 2017
Disposable vitals sensor maker VitalConnect has received a new FDA clearance, lengthening the life of its VitalPatch device from four days to five. VitalPatch is an FDA-cleared, disposable peel-and-stick health sensor, which continuously monitors eight different vitals (ECG, heart rate, heart rate variability, respiratory rate, skin temperature, posture, and steps, as well as automatic fall...
By Dave Muoio November 20, 2017
The FDA has approved hearing implant maker Cochlear Limited’s submission for a new remote feature that would allow specialists to perform follow-up programming on a patient’s cochlear implant remotely, a la a telemedicine platform. The feature for the company’s Nucleus Cochlear Implant System is indicated for those who have had at least six months of experience with their implant sound processor...
By Jonah Comstock November 17, 2017
Correction: An earlier version of this article was unclear about differences between Abilify MyCite and the Proteus Digital Medicine Platform.  Earlier this week, Proteus Digital Health and Otsuka Pharmaceuticals announced that Abilify MyCite, a new, sensor-enabled version of Otsuka’s drug for schizophrenia, had received FDA approval for mental health conditions including schizophrenia and...
By Jonah Comstock November 16, 2017
Medical device software company Voluntis has received an updated FDA clearance (as well as an updated CE mark) for its Insulia app, a "digital companion" app for people with Type 2 diabetes. Insulia offers realtime basal insulin dose coaching, and the new clearance makes the app usable with two additional brands of insulin: Basaglar and Tresiba. The app had already worked for users of Lantus,...