FDA

By Laura Lovett November 16, 2017
A new product that allows surgeons to pre-plan endovascular treatment of cerebral aneurysms was recently cleared by the FDA. EndoVantages’ SurgicalPreview is a cloud-based computer modeling platform that lets surgeons upload individual patient’s CT scans and then creates a 3D model of the brain with anatomical measurements.  A cerebral aneurysm, which is a weak spot in the blood vessel of the...
By Mike Miliard November 14, 2017
The first drug in the US with a digital ingestion tracking system has been approved by the FDA. The pill, Abilify MyCite, is prescribed for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression in adults. An ingestible sensor embedded in the pill is able to record that the medication was taken – sending...
By Jonah Comstock November 8, 2017
Now that the Abbott Freestyle Libre has received FDA clearance, Abbott and Dexcom will be forced into tight competition in the US market. On Dexcom’s third quarter call, CEO Kevin Sayer spent some time assuaging investor fears about that friction. “Late in the third quarter, the FDA approved Abbott's FreeStyle Libre flash glucose monitoring system,” Sayer said on the call. “We always believed the...
By Jonah Comstock November 7, 2017
FDA Commissioner Scott Gottlieb announced today that the agency intends to make a major change to its regulatory process around direct-to-consumer genetic health risk (GHR) tests. Specifically, the agency is creating a framework that will allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their processes, an approach reminiscent of the...
By Jonah Comstock November 2, 2017
On Fitbit’s third quarter earnings call yesterday, the company shared that, between spending cuts and the launch of the its long-awaited smartwatch, the company is pulling out of the earnings slump it’s been experiencing. The call also saw CEO James Park talking more than ever about the fitness wearable’s clinical applications and the ways in which those ambitions are coming to fruition. This...
By Jonah Comstock October 31, 2017
New York City and Guilford, Connecticut-based Butterfly IQ has received FDA clearance for an iPhone-connected portable ultrasound scanner that uses an easy-to-manufacture semiconductor chip rather than the piezoelectric crystals used by traditional ultrasounds. Because of the semiconductor chip, the device will be offered at a much lower price point than existing ultrasounds, including existing...
About the Authors: 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 issues.  Chris Bergstrom is a digital health leader, for The Boston Consulting Group (BCG). At BCG, he directs digital health initiatives across large payer, provider, med tech, and bio/...
By Jonah Comstock October 24, 2017
The FDA released two final guidances and a new draft guidance today to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the first qualified tool under the voluntary Medical Device Development Tools (MDDT) program. "Medical device technology evolves quickly. The process for improving the performance and clinical...
By MobiHealthNews October 20, 2017
Led by a new commissioner in Dr. Scott Gottlieb, the FDA had a busy few months with a handful of digital and mobile technologies getting cleared in the third quarter of 2017. Consumer-focused diabetes and pain management offerings were prominent, but but by and large the clearances hit a multitude of clinical concerns and, of note, even included the first software-only digital therapeutic....
By Jonah Comstock October 18, 2017
Pear Therapeutics announced today that reSET-O, a digital therapeutic for opioid use disorder, has received an Expedited Access Pathway (EAP) designation from the FDA. The EAP designation doesn't mean that the FDA has cleared the product, only that it has committed to fast-tracking it through the clearance process because of its timely public health value.  “The opioid epidemic continues to...