FDA

By Jonah Comstock September 1, 2017
Computers, whether through simple decision trees or complex neural networks, are increasingly playing a larger and larger role in helping healthcare providers make treatment decisions. As the role of clinical decision software in healthcare grows, so too does the need for guidelines that allow clinicians and patients to trust and understand that software. This week, the CDS Coalition, an industry...
By Jeff Lagasse September 1, 2017
Melbourne, Australia-based Adherium, a digital health company that focuses in improving medication adherence and patient outcomes, has just received FDA clearance for a new inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, dubbed the SmartTouch for Symbicort.   The SmartTouch is a device that grafts onto a patient’s inhaler to monitor and encourage medication adherence as...
By Jonah Comstock August 31, 2017
Bethesda, Maryland-based BrainScope, which makes mobile, non-invasive devices that help medical professionals assess traumatic brain injury, has raised $16 milion. New investor DBL Partners contributed along with existing investors Revolution LLC, ZG Ventures, and Maryland Venture Fund. “We are delighted to have closed this financing with such outstanding investors," Michael Singer, CEO of...
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...

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