April 2, 2021
The EU has approved an artificial intelligence (AI) technology that can identify people at risk of a fatal heart attack, years before it strikes.
The CaRi-Heart technology, developed by British Heart Foundation (BFH) spinout company Caristo Diagnostics, utilises coronary CT angiogram (CTTA) scans already performed in clinical practice.
It uses AI and deep-learning technology to produce a fat...
Credit: Aktiia monitoring bracelet
January 26, 2021
Maker of wearable continuous blood pressure monitor, Aktiia, today launched their 24/7 automated blood pressure monitoring system that gathers data during the day and while the user is asleep.
Aktiia has received its CE mark as a Class lla medical device, meaning that the device has been assessed to meet safety, health and environmental protection requirements in Europe.
The device is also now...
September 28, 2020
This morning Abbott announced that its continuous glucose monitor the FreeStyle Libre 3 earned a CE mark, making it cleared for use for individuals with diabetes living in the European Union. This news comes just a few months after the company landed the much-awaited U.S. FDA clearance for its FreeStyle Libre 2.
Like its predecessor this monitor can also last for 14 days and transmit glucose data...
September 21, 2020
Abbott announced that its Libre Sense Glucose Sport Biosensor has achieved a CE Mark, paving the way for a European roll-out.
The Libre Sense biosensor provides continuous glucose monitoring (CGM) to help athletes understand the efficacy of their nutrition choices on training and competition.
Based on Abbott's FreeStyle Libre technology for people living with diabetes, it is the first personal-...
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...
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...
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.
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...
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...
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...