FDA

By Dave Muoio April 15, 2019
Another recent update to the FDA’s 510(k) premarket notification database suggests that AliveCor is inching closer and closer to its next volley of smartphone-connected ECG products. According to the agency, the digital health company received clearance related to its KardiaMobile platform, as well as something called the KardiaStation, on Friday. The application for the device or devices was...
By Jonah Comstock April 3, 2019
FDA Commissioner Dr. Scott Gottlieb may be stepping down, but he isn’t slowing down on his way out the door. Yesterday the agency dropped a 20-page exploratory whitepaper on how it could address artificial intelligence and machine learning algorithms. “As algorithms evolve, the FDA must also modernize our approach to regulating these products,” Gottlieb wrote in a statement. “We must ensure that...
By Dave Muoio April 2, 2019
The Loop System, a continuous remote monitor developed by Palo Alto-based startup Spry Health, received 510(k) clearance from the FDA last Friday, according to an update to the agency’s database that was confirmed by the company. Designed for management of COPD and other chronic conditions, the wristband wearable collects and monitors a user’s pulse-oximetry, respiration, heart rate and blood...
By Laura Lovett March 28, 2019
Within the last few years the FDA has undergone a metamorphosis when it comes to digital health regulations. Though many of these are not yet solidified, a recent report by PricewaterhouseCoopers (PwC) predicts that these changes could open new doors for pharmaceutical companies looking to jump into the digital arena.  “Changes made by the FDA have made it easier for digital health products to be...
By Dave Muoio March 21, 2019
The FDA has lately taken a hard stance on tobacco companies targeting children and teens (thanks in some part to departing FDA Commissioner Dr. Scott Gottlieb), and it certainly seems as if the agency is exploring every avenue in its public awareness campaign — including free-to-play video games. Earlier this month the agency and its partner, marketing communications firm FCB New York, stealthily...
By Jonah Comstock March 21, 2019
This article has been updated with a new photo and additional information from Omron. Omron has apparently finally received FDA 510(k) clearance for its Blood Pressure Monitor + EKG device, which was originally announced in January 2018 at CES. The device was created in partnership with AliveCor. This is a separate product from Omron's HeartGuide watch, which also incorporates AliveCor ECG...

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 MobiHealthNews 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...