CE Mark

By Mallory Hackett 11:44 am September 14, 2020
Fitbit’s new electrocardiogram app has officially received regulatory clearance in the U.S. and European Union for its latest smartwatch, the Fitbit Sense, to monitor heart rhythm and detect atrial fibrillation. Now that the app has 510(k) clearance from the U.S. Food and Drug Administration and CE marking, Fitbit Sense users can access the ECG app beginning in October. The company conducted a...

Credit: Withings

By Tammy Lovell 02:59 am September 7, 2020
French digital firm Withings today announced that its latest wearable is available in Europe, after receiving the CE marking for medical devices. Developed by cardiologists and sleep experts, Withings says that ScanWatch is the world's first clinically validated hybrid smartwatch to detect both atrial fibrillation (AFib) and overnight breathing disturbances. The smart watch is designed to help...
By Laura Lovett 10:37 am December 4, 2019
Setting its sights on the European market, yesterday California startup VivaLNK announced that it landed a Class IIa medical device CE Mark for its multi-vital medical wearable sensor and software development kit.  Researchers and clinicians can use the technology to continuously stream a patient’s ECG rhythm, respiratory rate, heart rate, RR interval and three axis acceleration.  The product...
By Tammy Lovell 10:55 am February 7, 2019
The Association of British HealthTech Industries (ABHI) has reassured its members that a UK product safety mark to replace the CE mark in the event of a no-deal Brexit will not apply to medical devices. In the UK, all medical devices are subject to EU legislation, which requires manufacturers to place CE marks on their products to show compliance to applicable standards. Earlier this week, the...
By Jonah Comstock 11:57 am October 16, 2018
Netanya, Isreal telemedicine outfit Tyto Care, which specializes in incorporating connected devices into telemedicine encounters, has secured a CE Mark, allowing it to expand its offerings into Europe. Tyto Care’s offering includes a suite of connected devices designed to give remote doctors every tool that would be available in an in-person visit: a connected otoscope, stethoscope, basal...

The Freestyle Libre 1.

By Jonah Comstock 05:49 pm October 1, 2018
Abbott has received CE Mark clearance for the second generation of its Freestyle Libre device, which will allow the company to make the device available to users in Europe. It will be rolled out gradually in Europe starting in the next few weeks, and it will be offered as the same price as the first generation device. Freestyle Libre 1, which has been available in Europe since 2014, is a fully...
By Jonah Comstock 04:40 pm October 5, 2017
Paris-based Cardiologs has raised $6.5 million to support its AI-powered algorithm for ECG analysis. The round was led by a syndicate of investors including Idinvest, ISAI, Kurma Partners, and Partech Ventures, with additional participation from Bpifrance seed fund, an existing investor. This brings the company's total funding to $10 million. “Ambulatory ECG analysis and reporting is a labor-...
By Jonah Comstock 04:56 pm 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 04:39 pm 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 03:34 pm 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...