CE Mark

A doctor explaining a patient's findings from a reading by the Us2.v1 software.
By  Adam Ang 01:20 am June 9, 2022
Singapore-based medtech company Us2.ai is expanding to Europe after receiving a CE mark for its automated decision support tool for echocardiography. The Us2.v1 software is an automated clinical workflow solution that identifies and analyses two-dimensional and Doppler echo images for the diagnosis, prediction, and prognosis of heart disease and pulmonary hypertension. The company claims that its...
PocDoc, Poolbeg Pharma, CytoReason, CE mark, Boots, Caterpillar
By  Tammy Lovell 02:36 am April 1, 2022
PocDoc secures CE mark for digital reader of lateral flow testing Cambridge-based startup PocDoc has secured a CE mark for its artificial intelligence (AI) driven digital reader of lateral flow tests. The cloud-based system allows any smartphone or tablet to become a universal digital reader, so healthcare organisations can roll out lateral flow testing for any disease or marker at scale.   Steve...
A health worker wearing a surgical mask ties their head cap
By  Adam Ang 11:10 pm March 3, 2022
Intellect offers free mental healthcare access to health workers in Singapore Mental health startup Intellect has extended free three-month premium access to its mobile app for healthcare workers in Singapore. CEO and co-founder Theodoric Chew said in a statement that this is their way of giving back to the "healthcare heroes" who have been swamped due to the recent surge of COVID-19 cases. This...
NHS, funding, cannabis
By  Tammy Lovell 01:58 am February 18, 2022
Fertility startup ExSeed Health closes £2.5M seed round Male fertility startup ExSeed Health has announced the closure of  a £2.5 million seed extension round, led by Ascension with participation from Trifork, Hambro Perks, and R42 Group. The investment will drive further European expansion for the firm, which has teams in London and Copenhagen. ExSeed’s smartphone-based sperm testing kit does...
The NaoTrac by Brain Navi
By  Adam Ang 01:47 am November 25, 2021
Brain Navi Biotechnology, a Taiwan-based startup that creates navigation robots, has secured a CE mark for its robotic-assisted surgical robot for brain surgery. WHAT IT DOES Founded in 2015, Brain Navi mainly designs and develops medical devices that can assist surgeons during medico-surgical interventions. One of its products, the NaoTrac, is equipped with a high-precision navigation system...
Proov test kit
By  Mallory Hackett 11:39 am June 23, 2021
At-home fertility test maker Proov is expanding its footprint to Europe after receiving CE marking for its ovulation-confirming test kit. Proov’s ovulation testing kit got clearance by the FDA for sales in the U.S. last year. The test looks for Pregnanediol Glucuronide (PdG), a metabolite of progesterone produced in urine after ovulation. When elevated levels of PdG are detected in urine, it...
EyeYon Medical, CE Mark, EndoArt, corneal edema
By  Sophie Porter 08:29 am June 8, 2021
Israeli ophthalmology startup, EyeYon Medical, has received a CE Mark for its flagship product EndoArt, the world’s first synthetic corneal implant designed to counteract corneal edema. Edema is the excess build-up of fluids in the cornea caused by damaged endothelial cells, which usually regulate hydration levels in the eye. It can result in irreversible scarring, pain and even blindness....
By  Thiru Gunasegaran 10:45 pm May 31, 2021
Australian smartphone-based medical imaging company Advanced Human Imaging disclosed last week that it received a CE Mark for the dermatology artificial intelligence component in its DermaScan SaaS platform. WHY IT MATTERS According to the company, the DermaScan AI can accurately classify skin conditions from a photo captured by a smartphone camera. Using a large database, it can classify 588...
A doctor reading chest x-ray scans.
By  Thiru Gunasegaran 03:34 am April 21, 2021
SenseTime, an artificial intelligence company, has earned a CE mark to market its latest AI-powered diagnostic software that detects abnormalities in chest x-ray readings. WHY IT MATTERS Radiologists face heavy workloads in manually reviewing and analysing large quantities of CXR images daily. Misdiagnosis is also a concern due to the complexity of body parts being screened in CXRs. According to...
AI, CE Mark
By  Tammy Lovell 06:45 am 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...