Welcome to your monthly rundown of Radiology news and updates.
August can sometimes be a quieter month in the world of radiology and medical technology as a whole, with lot of vacations and time away slowing down momentum. That hasn’t really been the case this year with lots going on as the summer draws to a close.
August FDA Approvals
The month started with an updated list of AI/ML-enabled medical devices for the US from the FDA. (https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices).
This update came a little earlier than most people were expecting and included recent June approvals such as Tempus AI clearance for ECG-AF and Clarius Mobile Health approval for their OB AI product.
The total amount of authorised AI/ML-enabled medical devices is now up to 950, and should comfortably clear 1000 by the time of the next list.
When it comes to approvals in August, there has been several big updates:
- Siemens Healthineers announced that their new AI-enabled cardiovascular ultrasound system – ACUSON Origin.
- Sticking with cardiology, AISAP confirmed that their AI-powered POCUS solution ‘POCAD’, was granted 510(k) clearance, paving the way for this product being commercially available next week.
- And just last week, Metric Bio partner ai announced FDA clearance for their AI CT solution, qCT LN Quant.
Funding Updates
UK-based teleradiology company Hexarad announced their €13m growth round, led by MTIP.
I’ve been recruiting to the UK Teleradiology space for over 7 years, supporting established names such as Everlight Radiology and 4ways. This investment in Hexarad is clear testament to their team and the impact they are going to have on the space in the coming years. Congratulations to Farzana Rahman and team.
In the world on Pathology AI, PreciseDx confirmed their $20.7m Series B funding round, taking their total funding to $31.5m.
Aiming to “advance breast cancer diagnostics by delivering faster, more accurate data in a cost-efficient method”. PreciseDx will help set the stage for their next stage of in-depth clinical trials. I’m really looking forward to seeing what Eric Converse and the team can achieve in the coming years.
Partnerships & Acquisitions
As always, a number of interesting partnerships have been announced across radiology.
Blackford had a very busy month, announcing partnerships with both Imbio and CureMetrix into their portfolio.
CARPL – Radiology AI Platform and United Imaging Intelligence also confirmed their partnership, extending the reach of their leading CT AI applications for CCTA, pulmonary nodules and Bony Thorax Fractures.
Continued expansion for medical imaging platform companies such as Blackford , CARPL – Radiology AI Platform and deepc has been a real theme of the 2024 radiology landscape, and it’s not one I expect to slow down.
Offering a simplified, ‘one-stop shop’ for AI applications is something that is really resonating with the market, and seems to be route forward that avoids multiple installations, contracts and security frameworks with AI solution providers.
