FDA

By Jonah Comstock September 29, 2016
Medtronic came out with two pieces of news yesterday around its connected diabetes efforts: an FDA clearance for a MiniMed Connect closed loop system and the first test cohort of its Sugar.IQ app, created in collaboration with IBM Watson. The FDA approval of Medtronic’s MiniMed 670G hybrid closed looped system was announced by the FDA itself, as it’s the first automated insulin delivery system to...
By Jonah Comstock September 28, 2016
Abbott has received FDA Clearance for its FreeStyle Libre Pro system, a key milestone in bringing the company's unique take on the continuous glucose monitor to the United States. In Europe, where the system has had CE Mark clearance since September 2014, there is both a prescription and over-the-counter version available and the latter is smartphone compatible. "FreeStyle Libre Pro transforms...
By Jonah Comstock August 24, 2016
In June, the FDA offered up a draft guidance document designed to help medical device makers better understand how the agency thinks about a patient's right to access their own data from a device. The guidance clarified that medical device makers can make a patient's data available to them without additional clearance, though it cautioned them to do so thoughtfully to keep the data private and...
By Jonah Comstock August 23, 2016
The FDA has granted de novo clearance to two concussion assessment software products from ImPACT Applications. The Pittsburgh-based company developed its original software in the 90s for computers, though the clearance also includes ImPACT Pediatric, a newer version of the tests for children that runs on an iPad. "ImPACT's FDA clearance is a huge step forward for the industry, for athletes and...
By Jonah Comstock August 10, 2016
Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, announced preliminary results from its US pivotal trial, a major step toward receiving premarket approval from the FDA, on the same day as the company's second quarter earnings call. "We are at a significant point of change for not only acceptance and utilization but the recognition by...
By Jonah Comstock August 9, 2016
The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices. Lack of regulatory clarity is often cited as a force hampering innovation in digital health, so these moves by the FDA toward greater clarity are likely to be welcomed in many parts of the industry....
By Jonah Comstock August 3, 2016
Dexcom’s biggest triumph and its biggest let down this quarter both involved the FDA. On the positive side, a verdict from a special FDA panel means Dexcom may soon be able to change its CGM’s intended use to replace fingerstick glucometers. On the negative side, a voluntary device recall this quarter that potentially affected all of Dexcom’s receivers led to higher-than-expected Q2 losses....
By Jonah Comstock July 28, 2016
Companion Medical, a stealthy San Diego-based company that received funding last year from Eli Lilly and Company, has received FDA 510(k) clearance for its Bluetooth-connected smart insulin pen and associated mobile app, called InPen. "FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care," CEO Sean Saint, a veteran engineer of Dexcom, Medtronic, and...
By Jonah Comstock July 27, 2016
Akron, Ohio-based Intellirod Spine, a sensor-enabled spine implant company, has raised more than $1 million in a round led by new and existing investors, including Queen City Angel First Fund V and JumpStart. Previous investors include the Kentucky Seed Capital Fund and the City of Akron, Ohio. Intellirod Spine is developing wireless sensors that will measure the strain being put on implanted...
By Heather Mack July 22, 2016
An FDA advisory panel has voted in favor of recommending a change to the intended use of Dexcom’s G5 Continuous Glucose Monitor (CGM). The G5 had already been FDA-approved, but with limitations as an adjunctive device, meaning it could only be used for tracking and trending interstitial fluid gluocose concentrations rather than as a full replacement for a traditional fingerstick blood glucose...