FDA

By Jeff Lagasse August 28, 2017
NxStage Medical, a medical technology outfit focused on advancing renal care, has received clearance from the FDA for its System One, which allows for solo home hemodialysis, without a care partner, during waking hours.   The company received its first clearance for home hemodialysis from the FDA in 2005, and in 2014 was cleared for home nocturnal hemodialysis. Since then, NxStage estimates that...
By Bradley Merrill Thompson August 23, 2017
There seems to be a modern day gold rush as companies explore how to use machine learning in clinical decision support software. Unfortunately for libertarians, FDA will regulate some of that software because of its risk profile. While the 21st Century Cures Act that passed last December exempted certain CDS from regulation and indeed FDA intends to exempt even more, FDA will continue to regulate...
By Bill Siwicki August 22, 2017
Health IT vendors Interpreta and Higi are partnering to integrate biometric data from Higi with clinical, claims and genomic data from Interpreta. Interpreta works in the realm of precision medicine, continuously interpreting and synchronizing clinical and genomics data in real time to create a personalized roadmap to enable the orchestration of timely care, the company said. Higi operates the...
By Jeff Lagasse August 16, 2017
Diabetes therapy management software company Glytec has just secured its fourth FDA clearance, adding a slew of capabilities to its Glucommander product, the core of its eGlycemic Management System.   This latest FDA clearance incorporates some of the product enhancements that have been suggested by the company’s user community, including a titration module designed expressly for inpatients...
By Jonah Comstock August 11, 2017
As implantable CGM company Senseonics continues to wait for clearance from the FDA, the company isn't sitting on its hands. On a Q2 earnings call, CEO Tim Goodnow reported that the company continues to expand its operations in Europe, is close to a CE Mark for a longer-lasting second generation device, and is partnering with Roche and Type Zero on an artificial pancreas study with an eye on...
By Jonah Comstock July 31, 2017
Over the last month, several digital health companies have wound their way through the FDA clearance process. Although the details on some of these clearances are still emerging, the following is a snapshot of some of what the agency has been up to. Dictum Health's telemedicine platform Dictum Health, which makes an end-to-end telehealth platform, receieved clearance to add spirometry to the...
By Jonah Comstock July 27, 2017
The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr. Scott Gottlieb last month. Now the agency has opened up applications for a nine-company pilot program to develop the program. The basic goal of the Pre-Cert program, which sets it apart from previous...
By Jonah Comstock July 26, 2017
HIMSS has named Harold “Hal” Wolf III to be its new president and chief executive officer, following an extensive search process, the association announced Wednesday. He will succeed H. Stephen Lieber, who is stepping down as HIMSS CEO after more than 17 years. Wolf has more than three decades of experience working in healthcare and technology, with deep expertise in integrated care models,...
By Jeff Lagasse July 21, 2017
The FDA has been a busy agency these past few months. The second quarter of 2017 has seen a flurry of clearances, many for technologies that continue the trend toward mobile, or even wearable devices. It’s been a good period for those with diabetes, sleep disorders and traumatic injury, not to mention those just looking to maintain and manage their health – with a little digital help, of course....
By Jeff Lagasse July 20, 2017
Global digital health outfit DarioHealth Corp., which emphasises mobile health and data solutions, has been granted Pre-market Notification (510(k)) clearance for the Dario app on certain Android mobile devices by the U.S. Food and Drug Administration. Dario is a glucose meter that syncs with a companion app. The device, which is small enough to fit in someone’s pocket, consists of a glucose...