Abbott

By Jonah Comstock November 13, 2017
A number of digital health devices have recieved FDA 510(k) clearance in the last month, including a number of apps and devices in the cardiac health space. Some clearances are updates to companies that have one or more existing clearances, while some are newly cleared devices. Read on for a roundup of connected ECG sensors, medical device companion apps, and wearable patches. 1. St. Jude Medical...
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 Dave Muoio October 23, 2017
The FDA has cleared Abbott’s Confirm Rx Insertable Cardiac Monitor (ICM), an implantable device that continuously tracks patients’ heart rhythms and sends the data to a smartphone app via Bluetooth. With the clearance, Abbott will soon be rolling out the device in the US. The Confirm Rx ICM is placed just under the skin of the chest in a minimally-invasive outpatient procedure. Encrypted data...
By Jonah Comstock September 27, 2017
Abbott Diabetes Care's Freestyle Libre Flash Glucose Monitoring System has been approved by the FDA. As well as finally bringing the system, which is already available in 39 other countries, home to the US where Abbott is based, the approval also represents a first for continuous glucose monitoring, as it doesn't require the user to use a fingerstick, even for calibration. "From an emotional...
By Jonah Comstock September 13, 2017
Today was a big day in the world of diabetes management technology, with major announcements from Abbott, Livongo, and Senseonics. Read on below for a round-up of diabetes news. Livongo acquires Diabeto Mountain View, California-based Livongo Health, the chronic condition management technology company founded by former Allscripts CEO Glen Tullman, has acquired Diabeto, a diabetes management...
By Jonah Comstock July 19, 2017
Oscar Health is working with Humana to offer commercial health insurance to small businesses in a nine-county Nashville, Tenn. area. Tech-saavy insurance startup Oscar is teaming up with incumbent Humana at a time when it’s just begun to expand from the individual market into working with employers through its Oscar for Business unit. Humana will provide licenses to operate in Nashville as well...
By Jeff Lagasse July 17, 2017
Abbott and Bigfoot Biomedical have entered into an agreement to develop and commercialize diabetes management systems, integrating Abbott's FreeStyle Libre glucose sensing technology with Bigfoot's insulin delivery solutions.    Under the agreement, Abbott will supply glucose measurement sensors for all of Bigfoot's insulin delivery systems in the U.S. as the exclusive sensors for those systems...
By Jonah Comstock February 15, 2017
Abbott Diabetes Care shared some real-world evidence this morning at the International Conference on Advanced Technologies & Treatments for Diabetes, bolstering clinical trial data about the effectiveness of the company's Freestyle Libre device line. "We’re certainly committed to sharing as much information as is possible with our users and our health providers in order to be able to make...
By Heather Mack October 7, 2016
As we take a look at the devices that received FDA clearance in 2016's third quarter, we're also considering that the last few months have been a time of change at the Food and Drug Administration, as regulators are beginning to make updates in their system to accomodate all the digital health tools we're seeing.  In June, the FDA offered up a draft guidance document designed to help medical...
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...