FDA

An illustrated graphic of how the Nerivio Migra®​ device works. Source: Theranica

By Dean Koh March 19, 2019
Founded in 2016, Theranica, a biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, yesterday announced the closing of its round B of financing, of $35M, led by aMoon, Israel's largest healthcare VC. All existing investors of the company – Lightspeed Venture Partners, LionBird, Corundum Open Innovation and Takoa – participated in...
By Jonah Comstock March 13, 2019
  Correction: A brief originally included in this roundup, about Quip's funding, has been removed. The round in question was not new; it was previously reported here. ... With new investor, Klara heading to market. New York-based Klara, a healthcare messaging system, has secured a new investment from Stage 2 Capital. The amount of the investment was not disclosed. Klara brought Stage 2 in to help...
Some false or misleading guidances on FDA's website.
By Bradley Merrill Thompson March 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. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of Babyforyou.net.ua or HIMSS. As a pro bono project, together...
By Jonah Comstock March 7, 2019
Zoll Medical Corporation, which received FDA clearance a few years ago for both home and hospital versions of its wearable defibrillator LifeVest, is now dealing with a range of lawsuits and FDA actions over problems with the device. At least two people have died because their vests failed to activate due to an electrical problem, the FDA reports, while local media in Pittsburgh reports that...

Photo by Zach Gibson/Getty Images

By Jonah Comstock March 5, 2019
FDA Commissioner Dr. Scott Gottlieb has handed in his resignation as head of the agency, according to a report in the Washington Post, which has been confirmed by HHS Secretary Alex Azar in a statement posted to his Twitter page as well as by Gottlieb himself later in the day. He will resign in one month. "I’m immensely grateful for the opportunity to help lead this wonderful agency, for the...
By Jonah Comstock February 28, 2019
Toronto-based CardioComm, a longtime player in the handheld personal ECG space will finally make data available on consumers' smartphones with a new 510(k) clearance for its GEMS Mobile smartphone app, which works on both iOS and Android devices. The company also received clearance for a new ECG device called HeartCheck CardiBeat.  Notably, these are over the counter clearances, allowing the app...

Photo by Carsten Koall/Getty Images

By Dave Muoio February 26, 2019
FDA draft guidance on BCI devices. The FDA signaled its interest in the development of implanted brain-computer interface (BCI) devices on Friday with the release of a new draft guidance focused on the emerging technology. The new document suggests that non-clinical testing of the devices could precede clinical testing as a means to identify and prevent potential risks prior to use by patients. “...
By Laura Lovett February 25, 2019
This morning Spirosure, a health tech company focused on respiratory conditions, announced that its latest product the Fenom Pro Asthma Monitor has landed FDA clearance. The provider-facing technology enables clinicians to measure the fraction of exhaled nitric oxide (FeNO), an indicator of airway inflammation, in their patient’s breath. The technology uses proprietary algorithms to detect the...
By Dave Muoio February 25, 2019
Earlier this month, Hygieia’s d-Nav Insulin Guidance Service — an app that titrates insulin doses for individual Type 2 diabetes patients, regardless of their regimen type — received 510(k) clearance from the FDA. The cloud-based service leverages proprietary algorithms, users’ individual blood glucose data and a small team of in-house health professionals to generate and deliver insulin dosage...
By Philipp Grätzel von Grätz February 25, 2019
The FDA is taking a new approach to the regulation of digital medicine solutions. “Digital tools are rapidly evolving, and to keep pace with its promising innovation, the FDA must modernise its approach to regulation,” FDA Commissioner Scott Gottlieb said in a statement at the beginning of the year. The regulatory framework for the Software Precertification (Pre-Cert) Pilot Program has now been...
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