In today's article, Indo Search Director Josh Craven looks at what is new in MedTech and HealthTech this December.
Regulatory Horizons Council makes recommendations to UK government for the regulation of AI as a medical device.
The Regulatory Horizons Council (RHC), an independent expert committee that identifies the implications of technological innovation and provides the government with impartial advice on regulatory reform, has published an independent report on artificial intelligence (AI) as a medical device (AIaMD). The report analyses the current regulatory framework of AIaMD and highlights the challenges and regulatory gaps.
UK-based health tech raises £1.1M to help conduct hearing tests in three minutes.
Hearing Diagnostics, an Edinburgh-based health tech company has secured £1.1 million in funding. The investment round was led by Archangels, the world’s longest continually running angel investment syndicate. The funding will unlock the spatial hearing screening technology’s market potential.
Ada Health Receives EU-MDR Certification for AI-Powered Symptom Assessment Platform. The Ada Assess enterprise solution is among the first AI-based.
Ada Health GmbH ('Ada Health'), the global digital health company focused on improving human health at scale, today announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).
Device for early diagnosis of blood clots receives £500k Innovate UK grant.
Fallouh Healthcare is developing a device to monitor cardiac patients after surgery, when the condition, called cardiac tamponade, usually strikes.
Aston University receives £5m for digital health simulation facilities.
Aston University will use the investment to improve its health tech facilities, including a digital hospital ward to provide remote medical services and simulation training facilities for students of the college.
MedTech Innovation Awards submissions are now open - best of luck to all entries.
The Med-Tech Innovation Awards seek to celebrate the vital work of the medical device engineering community. The six categories reflect the areas of the sector where manufacturers are pioneering new territories and breaking new ground.
The deadline for entry submissions is 1st March 2023.
QuantuMDx receives UK approval for Q-POC COVID & Flu Assay.
This is the latest product offered by QuantuMDx to receive CTDA approval following the CTDA approval for the Q-POC SARS-COV-2 assay on 22 February 2022. Both assays, alongside the Q-POC system, are commercially available in the UK and Europe. Q-POC is CE-IVD marked under the In Vitro Diagnostic Regulation (2017/746), and both tests are CE-IVD marked under the In Vitro Diagnostic Directive (98/79/EC).
Innovative cane firm WeWALK receives a further £2m investment.
WeWALK, the company behind a smartphone-connected ‘smart cane’ for the visually impaired, has announced a £2 million investment round to help evolve its technology and grow its global market presence.