AI powered MedTech and Digital HealthTech:

HoloCare launches 3D surgical holograms across the UK and Europe in January 2024

Norwegian healthtech startup HoloCare scales its commercial footprint across the UK and Europe, following UKCA and CE certification. The mixed reality and AI-powered platform will initially launch in five hospitals to support pre-surgical planning.

HoloCare’s software creates interactive 3D holograms of an individual patient’s organ, allowing surgeons to precisely plan and personalise surgeries to the patient’s unique anatomy. This better spatial understanding could support surgeons to carry out operations more efficiently and accurately – helping improve wait times, improve patient surgery outcomes, and improve clinician wellbeing.

AIRS Medical Receives EU Medical Device Regulation CE Certification for SwiftMR™ in January 2024

AIRS Medical, a leading AI-powered healthcare solution provider, is thrilled to announce that it has received EU Medical Device Regulation (MDR) CE certification for its AI-powered MRI enhancement solution 'SwiftMR™'. This certification allows AIRS Medical to sell its flagship product, 'SwiftMR™,' across the EU (27 countries), Turkey, EEA (Liechtenstein, Iceland, Norway), Great Britain, and Switzerland.

Easee receives CE mark under MDR for online eye exam DECEMBER 2023

Easee, a digital healthcare speicalist, has achieved the CE mark Class II under the new European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR) which the company says is the world's first and only CE certified online eye exam with refraction capabilities. 

Biospectal obtains CE mark for blood pressure monitoring app December 7, 2023

Starting early next year, the app will initially be available in France, Germany, Austria, and Switzerland.

Biospectal has obtained European CE MDR Class IIa medical device certification for its OptiBP optical fingertip blood pressure monitoring app.OptiBP is claimed to be the first and only software app globally to receive the CE mark to measure blood pressure on a smartphone.

Lucida Medical receives CE mark for AI prostate cancer detection software in October 2023

Lucida Medical, a Cambridge-based start-up, has received Class IIb CE certification for its AI-based prostate cancer detection software, Prostate Intelligence (Pi). Built in partnership with leading clinicians and NHS hospitals, the CE mark means the software can be used across the UK and European healthcare systems.

While MRI is the preferred imaging technique to assess a range of cancers, including prostate cancer and metastatic disease, in the UK alone, radiologist numbers are forecasted to reach a shortfall of 40% by 2027, indicating a need for a streamlined, simplified, and accurate means for cancer diagnosis.

Theranica’s migraine therapy receives expanded CE mark approval in August 2023
Theranica has secured extended CE mark approval for Nerivio as a dual-use therapy for acute and preventive migraine treatment for adolescents and adults in August 2023

The self-administered therapy is controlled through a smartphone app. Nerivio wraps around the upper arm and employs sub-painful remote electrical neuromodulation (REN) for activating nociceptive nerve fibres in the arm.