MetaMedical™ Solutions Inc

FDA issues 510(k) clearance for Implicity’s SignalHF1 algorithm

The US Food and Drug Administration (FDA) has issued 510(k) approval to Implicity’s heart failure prediction algorithm, SignalHF1, designed to work with its remote monitoring solution.

Implicity is said to have leveraged one of the world’s largest heart disease patient databases, Health Data Hub, to train and validate its machine-learning algorithm.

The SignalHF1 algorithm is capable of assessing the risk of future heart failure events, thus enabling timely intervention by physicians to prevent hospitalisations.

Implicity CEO and cardiologist Dr Arnaud Rosier said: “Heart failure remains a significant healthcare challenge, contributing to approximately one million hospitalisations each year. Preventing even a portion of these would be a game-changer in cardiac care.

“SignalHF is an innovative and effective tool that physicians can use to assess the risk of hospitalisation due to heart failure earlier, enabling interventions that can lead to better outcomes and reduce hospital admissions.”

The SignalHF1 algorithm can analyse data collected from various cardiac implantable electronic devices (CIEDs), including implantable cardiac defibrillators (ICD), pacemakers (PM) and cardiac resynchronisation therapy devices (CRT-P, CRT-D) from companies such as Biotronik, Boston Scientific, and Medtronic.

Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free

Your download email will arrive shortly

We are confident about the
quality of our Company Profiles. However, we want you to make the most
decision for your business, so we offer a free sample that you can download by
submitting the below form

By GlobalData

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

It is also said to be the first compatible algorithm with pacemakers.

The algorithm automatically alerts care teams when a patient’s risk score exceeds a certain threshold, indicating a high risk of imminent heart failure and potential hospitalisation.

Implicity data head Issam Ibnouhsein said: “Comprehensive heart failure management includes treatment, prevention, and personalisation. Implicity’s solution is part of this approach. Our alerts are generated in context with a patient’s medical profile to help personalise care management plans.

“Furthermore, 75% of the alerts preceding a patient hospitalisation are sent at least 14 days in advance – offering a two-week window to adjust medications or take proactive measures.”

Last year, Implicity launched a new algorithm for reducing alert fatigue in the remote monitoring of patients with atrial fibrillation.

Source link