April 13, 2017
Apple has even more secret health aspirations than anyone realized, according to reporting by Christina Farr for CNBC yesterday. Citing sources inside the company, Farr reports that Apple has a small offsite team dedicated to diabetes research that's been working for about five years.
The goal is one many other tech companies are working on but no one's close to cracking: noninvasive, continuous...
March 24, 2017
In January, the Centers for Medicare and Medicaid Services announced that it would cover continuous glucose monitoring for the first time; specifically it would cover therapeutic CGMs, of which the only one currently recognized is the Dexcom G5. That coverage officially kicks in today, now that CMS has issued the billing codes providers can use to get reimbursed.
“This is a new era and a huge win...
March 3, 2017
Implantable longterm continuous glucose monitor company Senseonics is in a better place than its financials would suggest. The company posted a net loss of $9.9 million last quarter, up from an $8.4 million loss in the year prior, and is planning to borrow about $5 million from the Oxford Silicon Valley Bank that it’s already $20 million in debt to.
But Senseonic’s potentially game-changing...
March 1, 2017
After the latest in a series of successful quarters (with $171.2 million in revenue, up 31 percent year over year), DexCom is queuing up some big product launches. On yesterday’s Q4 earnings call, CEO Kevin Sayer provided more detail about the forthcoming G6 continuous glucose monitor as well as the first products to come out of DexCom’s partnership with Verily.
“In a year of much confusion and...
February 15, 2017
GluSense, an Israeli medical device company, announced an undisclosed investment from the JDRF T1D Fund, a recently launched VC philanthropy fund dedicated to funding early stage programs for Type 1 diabetes. GluSense is being incubated in the Rainbow Medical innovation house, a private investment company that seeds and grows medical device companies.
The company’s first product in development is...
December 20, 2016
The FDA has officially cleared the Dexcom G5 continuous glucose monitor to inform treatment decisions -- without the use of a fingerstick glucometer, other than for calibration. The G5 has been cleared for a while to complement a traditional glucometer, but this non-adjunctive clearance is the first of its kind according to Dexcom and the FDA, which both released statements.
"The FDA works hard...
November 9, 2016
Senseonics, the Germantown, Maryland-based company which went public in January and is working on a longterm implantable continuous glucose monitor, has submitted its PMA application to the FDA, President and CEO Tim Goodnow said on the company's third quarter earnings call last week. In addition, the company continues to work on a second generation device and its first pediatric clinical trial...
July 19, 2016
Medtronic has received a CE Mark for its Guardian Connect mobile continuous glucose monitor (CGM) and app. The company will begin selling the system in select countries in Europe, Asia, and Latin America in Q2 2017 and expects to receive FDA clearance to launch the device in the US around that same time.
The Dublin, Ireland-based company already has an FDA and CE cleared connected CGM called...
May 25, 2016
Medtronic announced that it will work with Qualcomm Life to develop a new generation of smaller, affordable continuous glucose monitors (CGMs) for people with Type 2 diabetes, the companies announced today.
Currently, CGM devices are mostly prescribed for people with Type 1 diabetes, while those with Type 2 are more likely to use discrete finger-prick glucometers. However, this new partnership...
May 11, 2016
Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, has received a CE Mark for its Eversense Continuous Glucose Monitoring (CGM) System.
“The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards,” Senseonics CEO and President Tim...