Dear Friend;Dr. George Adams ICD.D Executive-Chairman ππ Dear Friend;
Attached is today’s news release about the 510(k) submission to the FDA for VMS+4.0. Here is some background.
1. VMS+4.0 is the next generation product which has a number of features to make it more user friendly and provide automated analysis using conventional AI to select the anatomical landmarks in the heart. It really is a breakthrough product as automated analysis has been a goal for the entire industry for decades. Some systems gove automated analysis of one of two measurements on the left ventricle but the VMS+4.0 is the only system which provides a complete analysis of the whole heart.
2. VMS+4.0 has been licensed by Health Canada and has obtained a CE Mark for Europe and UK.
3. The Company submitted to the FDA last year and received a request for more information, which required additional testing. This testing was positive and so the 510(k) file has been updated and re-submitted to the FDA for review.
4. The FDA usually reviews updated 510(k) submissions quickly and so we would expect to receive a response in the next 30-60 days, which may be more questions or approval.
5. The FDA has been upgrading its approach to AI submissions. Here is an article on their approach. https://cardiovascularbusiness.com/topics/artificial-intelligence/fda-regulator-examines-ais-growing-influence-cardiology?utm_source=newsletter&utm_medium=cvb_news.
Thank you for your continued interferes and support as we change cardiac care for everyone everywhere and especially for children born with a heart defect.
PS: we still have the convertible debenture financing at $0.10 open and I encourage you to invest to help the company to market and drive adoption of VMS+4.0.
Regards,
Dr. George Adams ICD.D
Executive-Chairman
Ventripoint Diagnostics Ltd.
TSXV-VPT
www.ventripoint.com
519-803-6937