FDA

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 One draft guidance is the long-awaited guidance on clinical (as well as patient) decision support, while the other deals with changes to medical software policy based on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,...
By Laura Lovett November 16, 2017
A new product that allows surgeons to pre-plan endovascular treatment of cerebral aneurysms was recently cleared by the FDA. EndoVantages’ SurgicalPreview is a cloud-based computer modeling platform that lets surgeons upload individual patient’s CT scans and then creates a 3D model of the brain with anatomical measurements.  A cerebral aneurysm, which is a weak spot in the blood vessel of the...
By Mike Miliard November 14, 2017
The first drug in the US with a digital ingestion tracking system has been approved by the FDA. The pill, Abilify MyCite, is prescribed for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression in adults. An ingestible sensor embedded in the pill is able to record that the medication was taken – sending...
By Jonah Comstock November 8, 2017
Now that the Abbott Freestyle Libre has received FDA clearance, Abbott and Dexcom will be forced into tight competition in the US market. On Dexcom’s third quarter call, CEO Kevin Sayer spent some time assuaging investor fears about that friction. “Late in the third quarter, the FDA approved Abbott's FreeStyle Libre flash glucose monitoring system,” Sayer said on the call. “We always believed the...
By Jonah Comstock November 7, 2017
FDA Commissioner Scott Gottlieb announced today that the agency intends to make a major change to its regulatory process around direct-to-consumer genetic health risk (GHR) tests. Specifically, the agency is creating a framework that will allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their processes, an approach reminiscent of the...