Multiple FDA clearances for AI-powered products!
The United States Food and Drug Administration is an agency which certifies medical products in the United States, so they can be used by patients and doctors. In November 2022, FDA gave 510(k) clearance to products for diabetes and Parkinson’s disease detection. Such clearance doesn’t require verification of the products via clinical trials, but requires safety and effectiveness checks by FDA.
The clearance was given to AEYE Health, which uses AI to diagnose diabetes using retinal images, and to H2O Therapeutics, who created the Apple Watch app to monitor early signs of Parkinson’s disease such as tremors or dyskinesia.
Why do we think it’s important? FDA clearance for AI-powered products shows that, with proper preparation, AI devices can be trusted by professionals to be used in patient care.
Apple AirPods Pro with a potential to be a hearing aid?
Clinical trials show that Apple AirPods Pro have a potential to be used as a hearing aid given some constraints regarding the environment. It appears that in a quiet environment and when the noise comes from the side, AirPods can achieve similar speech reception levels as dedicated hearing aid devices. Another constraint is the extent of a hearing problem, as AirPods show promise mainly for people with mild to moderate loss.
Why do we think it’s important? Having a widely available hearing aid device such as commercial earphones can lower the cost of professional hearing aid devices. Moreover, as MedTechDive notices, devices that are used by other people can decrease the stigma associated with hearing aids.
Read more: here
Better liver cancer diagnostics with artificial intelligence
Scientists from John Hopkins University of Medicine and Bloomberg School of Public Health published a paper that shows improvement in liver cancer detection. They applied machine learning algorithms to blood samples of about 700 patients and found out that they can detect changes in cell-free DNA fragments of the blood. This results in an increase in early cancer detection when compared to standard tests.
Why do we think it’s important? Liver cancer detection is difficult because of low accessibility to testing procedures and its low performance. The proposed approach increases the number of correctly identified patients almost 2 times and can save lives by detecting the cancer risk earlier.
Read more: here
Towards equality in medical devices
Can medical devices discriminate? Apparently, pulse oximeters can work drastically differently for Black and White people, for example because of different skin pigmentation which impacts the measurement. However, Masimo released a peer-reviewed paper which shows that their SET pulse oximeters have stable results, regardless of racial differences. This can be a result of using additional signal processing methods which target factors like skin pigmentation directly.
Why do we think it’s important? If we want to create trustworthy healthcare, it needs to be equal to every patient. Improvements like this are an important element in product development and we’re happy to see them being done by companies.
Read more: here
Who are we?
MIM Solutions is a company which gathers best-in-class Artificial Intelligence experts from Poland who revolutionise MedTech by creating fertility-improving products (MIM Fertility) and helping other companies reach their highest potential with the use of AI (MIM.AI).
Why are we sharing the news?
We believe that knowledge is power, and therefore we want you to be up to date with what is happening in MedTech. We will share such news at the end of each month to show you how MedTech is growing and how we as MIM Solutions are contributing to this growth. Stay tuned for more interesting information from the MedTech world!