Dave Muoio

By Dave Muoio 03:04 pmMay 23, 2019
Amazon is building a wrist-worn device and accompanying app that listens to the wearer’s voice to identify their emotions, according to an anonymous source as well as internal documents acquired and reported on by Bloomberg. The system, codenamed Dylan, is intended to be used as a health and wellness product, and might be adapted to provide the wearer guidance on how they may more effectively...
By Dave Muoio 04:18 pmMay 22, 2019
ECG, eh? The Apple Watch Series 4’s ECG and irregular heart rhythm notification functions have received approval from Canada’s health product regulator, according to listings on Health Canada’s website that were recently spotted by iPhone in Canada. With these in hand, its likely that devices owners living in the Great White North will soon have access to features that have so far been activated...
By Dave Muoio 03:45 pmMay 22, 2019
Comcast is actively working on an in-home device for monitoring the health of seniors, people with disabilities and other at-risk individuals, according to anonymous sources cited by CNBC (whose parent company NBCUniversal is owned by Comcast). The telecommunications giant is planning pilots of the device and service before the end of the year, and could potentially aim for a 2020 commercial...
By Dave Muoio 03:07 pmMay 22, 2019
The FDA has put out a call for new companies to test drive the current framework of its Digital Health Software Precertification Program, the ongoing effort to streamline regulation of digital health products prone to frequent update. Organizations that are expecting to sponsor either a 510(k) submission or De Novo Request for a software as a medical device (SaMD) during 2019 or early 2020 are...
By Dave Muoio 03:48 pmMay 21, 2019
Minneapolis-based NightWare — maker of a smartwatch therapeutic for people with nightmare disorder and PTSD-driven nightmares — has received breakthrough therapy designation for its in-development product. In addition, the company is launching two new placebo-controlled randomized clinical trials for its digital intervention, one of which is being conducted within Department of Veterans Affairs...
By Dave Muoio 12:03 pmMay 21, 2019
Cala Health, a wearable neuromodulation therapy startup focused on chronic diseases, has closed a $50 million Series C financing round. Novartis, Baird Capital, LifeSci Venture Partners, TriVentures and other unnamed backers participated, as did returning investors JJDC, Lux Capital, Lightstone Ventures, Action Potential Venture Capital, dRx Capital and GV. WHAT THEY DO Stanford University...
By Dave Muoio 10:03 amMay 21, 2019
This morning Verily announced a series of new strategic partnerships with four global pharmaceutical companies that will bring low-burden digital data collection and analysis tools to clinical research projects. Alongside Novartis, Otsuka, Pfizer and Sanofi, the Alphabet subsidiary will employ its Project Baseline platform to increase the number and diversity of study populations by making it...
By Dave Muoio 03:18 pmMay 20, 2019
Easy access CME. The American Medical Association has launched an online continuing medical education (CME) tool for healthcare workers. The tool, called AMA Ed Hub, allows clinicians to earn, track and report CME credits across a range of topics and specialities, and includes content from sources like the JAMA Network’s JN Learning and the American College of Radiology. “The AMA is committed to...
By Dave Muoio 12:26 pmMay 20, 2019
On Friday, the FDA issued a warning to patients and providers describing the dangers of diabetes management devices and software that haven’t been assessed by the agency. These include any unapproved or unauthorized continuous glucose monitors, insulin pumps and automated insulin dosing systems, whether used as a standalone device or integrated as part of a glucose management system. “These...
By Dave Muoio 03:36 pmMay 16, 2019
Help from above. The Department of Justice has taken the side of tech-enabled insurer Oscar Health in a federal antitrust suit it filed in November of last year against Florida Blue, Crain’s New York Business reports. While Oscar’s motion for a temporary injunction was rejected by a federal judge back in February, the DOJ filed a statement in April arguing that Florida Blue had incorrectly...