FDA

By Dave Muoio February 19, 2019
Last week the FDA granted its first marketing authorization to an interoperable insulin pump that is compatible with automated insulin dosing systems, continuous glucose monitors, blood glucose meters and other diabetes therapy devices built by different manufacturers. The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of...
A generic startup

Photo by Caiaimage/Chris Ryan

By Bradley Merrill Thompson February 8, 2019
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.  In January, FDA released version 1.0 of its Working Model for the agency’s Precertification Program for Software as a Medical Device (SaMD) (i....
By Dave Muoio February 6, 2019
The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product categories. The proposed premarket guidance, which may still be adjusted based on public feedback, broadly advises industry to submit a single regulatory application within the pathway that most closely...
By Laura Lovett January 28, 2019
This morning medical device company Masimo announced FDA clearance for the measurement of respiration rate from a photoplethysmogram (RRp), so that it may now be used on the MightSat Rx finger pulse oximeter. The latest clearance also means the technology can be used at home by patients.   The new technology will be able to calculate a user’s respiration rate, which is the count of breaths per...
By Laura Lovett January 23, 2019
Looking to modernize the 510(k) process, yesterday the FDA announced its final guidance establishing the framework for the new Safety and Performance Based Pathway.  The biggest change to the 510(k) program is that instead of testing a new device in comparison to what is already on the market, new technology seeking clearance can be measured against a set of “objective, transparent and well...
By Laura Lovett January 18, 2019
This morning Alphabet’s life science subsidiary Verily announced that its Verily Study Watch and its on-demand ECG feature landed a 510(k) clearance from the FDA. The watch is a prescription-only device, and was designed to record, store, transfer and display single-channel ECG rhythms. The company said the device’s ability to take on-demand, single-lead ECG can be used for individual patient...
By Jonah Comstock January 11, 2019
The Embrace2, a seizure monitoring wearable from Boston and Milan-based Embrace, has received an updated FDA clearance that allows it to be used by children ages six and up — the first such device to receive clearance for pediatric use. "The fact that this is the first clearance of its kind in epilepsy highlights how difficult it is to get robust results with pediatric patients in a clinical...
By Dave Muoio January 10, 2019
The FDA has granted 510(k) clearance to an over-the-counter handheld electronic device for treating hay fever sinus pains, according to an announcement from its manufacturer. Tivic Health Systems’ ClearUP Sinus Pain Relief device is non-invasive and does not rely on a pharmacological component. Instead, the single-button device is run along the skin of the user's cheek, nose and brow, where it...
By Dave Muoio January 2, 2019
As America rises to greet the new year, its leaders remain in a funding dispute over border security that has so far resulted in 13 days of a partial government shutdown. While the deadlock is certainly having a prolonged impact on more than 420,000 government employees who are working without pay, and the 380,000-plus who have been furloughed, each passing day threatens greater challenges for...
By Dave Muoio December 31, 2018
Jerusalem-based Teva Pharmaceuticals’ sensor-packed, app-connected digital inhaler has recently received marketing approval from the US FDA, according to a release from the company. The device will first become available next year through a “small number” of healthcare system pilot partnerships, with a full national launch currently planned for 2020. Teva’s ProAir Digihaler is indicated for the...