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...
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In June, the FDA offered up a draft guidance document designed to help medical...
September 14, 2016
Health insurance startup Oscar Health welcomed Dr. Shaden Marzouk as new chief medical officer to the company. Marzouk joins the company from Cardinal Health, where she served as senior vice president of clinical operations and was responsible for leading acquisition and integration of new businesses in devices, services and analytics. Prior to that, Marzouk was chief of neurosurgery at William...
August 12, 2016
Over the years, more and more companies have gone public in the digital health space and existing public companies have gotten into the space, either on their own or thorugh acquisitions. Here's a roundup of digital health talk on the latest round of second quarter investor calls and quarterly finance reports.
Fitbit. San Francisco-based Fitbit, maker of a series of popular wearable activity...
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...
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...
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...
August 12, 2015
Germantown, Maryland-based continuous glucose monitor device maker Senseonics raised $10 million, according to an SEC filing.
The company has not yet responded to a request for comment.
Existing investors include Anthem Capital, Delphi Ventures, Greenspring Associates, Healthcare Ventures, and New Enterprise Associates. This brings the company’s total funding to at least $94 million to date....
June 6, 2014
Germantown, Maryland-based continuous glucose monitor developer Senseonics raised $20 million from existing investors Anthem Capital, Delphi Ventures, Greenspring Associates, Healthcare Ventures, and New Enterprise Associates. This brings the company's total funding to at least $84 million to date.
Senseonics will use the funds to obtain a CE mark and start investigational device exemption (IDE) ...