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...
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-...
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...
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...
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...
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...
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...
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...