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...
April 13, 2016
As their famous rallying cry states, the patients behind the Nightscout project for creating a do-it-yourself mobile technology for diabetes management are not waiting for approval from the FDA. But that doesn't mean they aren't seeking it, or that they haven't been in contact with the regulatory organization to make sure Nightscout is as safe as it can be.
In a new editorial published in the...
April 6, 2016
Susannah Fox, current Chief Technology Officer at HHS and former Pew researcher, knows it's a little odd that, as CTO, her background is in anthropology, not technology. But she thinks it's also illustrative of the role technology has to play in healthcare.
“We’re living through this time right now where technology is a Trojan Horse for change,” Fox said yesterday at HxR in Boston. “We say...
March 22, 2016
Researchers from Massachusetts flexible electronics company MC10 and from Seoul National University in South Korea have created a prototype skin patch that could both monitor blood glucose levels and administer drugs like insulin or Metformin to patients with diabetes.
In the study, recently published in Nature Nanotechnology, researchers used a combination of graphene and gold mesh to create the...
March 15, 2016
When the Apple Watch launched last year, Dexcom announced that it would have an Apple Watch app ready for its G4 continuous glucose monitor system, and it did. While users could see their CGM data on their wrist, that data had to go on a long trip to get there. With the G4, the implant sent data to a receiver box which sent data to the phone which sent data to the watch, and the user needed to...
February 4, 2016
Germantown, Maryland-based Senseonics' Eversense continuous glucose monitor, which promises to be less invasive and longer lasting than traditional CGMs, still isn’t FDA cleared or CE-marked. But the company, which filed for an IPO last month, is pushing ahead on a partnership to maximize the user experience of its device, and to establish a pipeline for sending its data to users’ healthcare...
January 14, 2016
Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, has filed to go public with an IPO that, for now at least, is valued at $51.75 million.
Senseonics singular offering is a pill-sized sensor that is entirely implanted in the user’s upper arm so that it can continuously monitor their glucose levels. The device is meant to last at least...
November 11, 2015
When Kenneth Stack's son was diagnosed with Type 1 diabetes just before his fifth birthday, the doctor told Stack he was just a few years too early for a major medical breakthrough.
"I remember, trying to make sense of all of this, the doctor saying 'In three years, we’ll have perfected the artificial pancreas and you won’t have to worry about this'," Stack recalled at a panel discussion at the...
August 25, 2015
The FDA has approved San Diego, California-based Dexcom for a Bluetooth-enabled continuous glucose monitor (CGM), called the G5 Mobile CGM system.
Correction: A previous version of this article incorrectly stated the device had a 510(k) clearance when in fact it had a PMA approval.
Unlike the company's previous connected CGM devices, the G5 Mobile CGM System has Bluetooth built right in to the...
August 6, 2015
The Dexcom G4 receiver
Continuous glucose monitors are right now a good tool for a certain subset of people with diabetes, but there's still a majority of people, especially with Type 2 diabetes, for whom fingerstick glucometers are still the cheaper, more convenient option. Dexcom wants to change that.
On a second quarter earnings call, EVP of Strategy and Product Development Steve Pacelli ...