CE Mark

By Jonah Comstock August 11, 2017
As implantable CGM company Senseonics continues to wait for clearance from the FDA, the company isn't sitting on its hands. On a Q2 earnings call, CEO Tim Goodnow reported that the company continues to expand its operations in Europe, is close to a CE Mark for a longer-lasting second generation device, and is partnering with Roche and Type Zero on an artificial pancreas study with an eye on...
By Jonah Comstock February 16, 2017
A Swiss medical device company is working on a medically accurate sensor, built into a smartphone, that could return results about heart rate, respiration rate, blood oxygenation, temperature, and -- the use case the company is initially focusing on -- blood pressure. Leman Micro Devices (or LMD or Elemdy) is beginning trials now to simultaneously submit the device for regulatory clearance with...
By Heather Mack February 7, 2017
Telemedicine provider American Well has announced two new partnerships with health systems and payers. In Indiana, several members of the Suburban Health Organization – a hospital partnership that works to promote patient access and efficiency in the system – will collaborate with American Well to bring video telehealth visits to SHO’s local patient population. The new service is called...
By Heather Mack December 6, 2016
Paris, France and Cambridge, Massachusetts-based Voluntis, which makes companion software for medical devices or medications, has received both FDA clearance and the CE Mark for a type 2 diabetes management app called Insulia. The app, which is designed for people treated with basal insulin, is classified as a prescription-only medical device and will be available to patients and healthcare...
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  In June, the FDA offered up a draft guidance document designed to help medical...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 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 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 Jonah Comstock 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...
By Jonah Comstock June 27, 2016
The UK’s unexpected referendum vote to leave the EU last week likely won’t take effect for another two years at least, but the potential consequences of the decision are already generating discussions in every industry, and digital health is no exception. Today the European Connected Health Alliance (ECHAlliance), a Belfast, Northern Ireland-based nonprofit collaborative with a mission to “...
By Jonah Comstock June 1, 2016
Roche Diagnostics has launched a Bluetooth-connected device for testing blood coagulation in Europe. The CoaguChek INRange system has received a CE Mark, and an older version of the device without the Bluetooth connectivity is already available in the US and in Europe. The Bluetooth connectivity allows patients undergoing Vitamin K antagonist therapy to self-monitor their blood coagulation with a...