August can sometimes be a quieter month in the world of radiology and medical technology as a whole, with a 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.
FDA Approvals
The month started with an updated list of AI/ML-enabled medical devices for the US from the FDA.
This update came a little earlier than most people were expecting and included recent June approvals such as Tempus’ clearance for ECG-AF and Clarius’ approval for their OB AI product.
The total number of authorized 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 other approvals in August, there have been several big updates:
- Siemens Healthineers announced 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 to be commercially available next week.
- And just last week, Metric partner Qure.ai announced FDA clearance for their AI CT solution, qCT LN Quant.
Funding Announcements
- MTIP announced its investment into UK-based teleradiology company, Hexarad, leading its €13m growth round.Having recruited in the UK teleradiology space for over 7 years, supporting established names such as Everlight Radiology and 4Ways, it’s clear this investment in Hexarad is a testament to their team and the impact that Hexarad is going to have on the space in the coming years. Congratulations, Farzana Rahman and team.
- In the world of Pathology AI, PreciseDx confirmed their $20.7m Series B funding round, taking their total funding to $31.5m.PreciseDx aims to “advance breast cancer diagnostics by delivering faster, more accurate data, in the cost-efficient method.” I’m really looking forward to seeing what Eric Converse and the team can achieve in the coming years.
Partnerships and Acquisitions
As always, a number of partnerships have been announced across radiology, including:
- Blackford had a very busy month, announcing partnerships with both Imbio and Curemetrix in their portfolio.
- Carpl.AI 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.AI, 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 the route forward that avoids multiple installations, contracts, and security frameworks with AI solution providers.
