FDA

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- 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...
By Dave Muoio December 21, 2018
The last few months of 2018 have been fairly active for digital health regulation, with the US FDA roughly a dozen noteworthy devices and consumer health products. But the bigger news out of the agency this quarter comes in the form of its market guidance. For instance, the very beginning of October saw the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response...
By Dave Muoio December 20, 2018
This morning, Omron Healthcare announced that the HeartGuide wristwatch — a wearable oscillometric wrist blood pressure monitor unveiled earlier this year at CES 2018 — has received FDA clearance and will be available at retail on January 9, 2019. The device is currently available for preorder for $499. The key feature of the product is a flexible synthetic band that is designed to inflate and...
By Laura Lovett December 18, 2018
Yesterday Teladoc’s VP, COO and CFO Mark Hirschhorn resigned amidst allegations that he engaged in an inappropriate sexual relationship with a subordinate and took part in insider trading. Last week the telemedicine company was hit with a class action lawsuit filed on behalf of the company’s share holders, which accused the company of misleading or false statements.  “While this was a difficult...
By Dave Muoio December 18, 2018
The FDA has approved an app-based smart programming device used to discreetly and easily control implants treating for overactive bladder (OAB), chronic fecal incontinence (FI) and non-obstructive urinary retention, medical device maker Medtronic announced yesterday. Called the InterStim smart programmer and designed for use with Medtronic’s InterStim system, the product consists of a Samsung...
By Dave Muoio December 4, 2018
De Novo rule proposal published for review. The FDA has published a new proposal for revisions to the De Novo regulatory pathway for devices without a predicate. The rule, which is currently available for public comment, aims to provide additional structure, clarity and transparency to the process, and outlines how the agency processes and gauges submitted devices. “Our goal is to make the De...

Editor's Pick

steroid-pharm.com/oxandrolon.html

steroid-pharm.com

https://pillsbank.net