MedTech AI Monitor W44

Welcome, MedTech Professionals.

W44 Edition of The MedTech AI Monitor

Hey there,

Welcome to this week's edition of the MedTech AI Monitor, where you get a quick update on what is going on in the AI world.

What’s important, and what’s not.

This week's topic: Peerbridge's AI-Enabled Wearable ECG Device 510(k) Strategy.

Have a great rest of the week!

-Greg

"too long; didn't read":

ECG wearable uses AI to detect heart issues and alert doctors
Submission will leverage both predicate device and De Novo device
Model trained using 90,000+ Mayo Clinic patients' data

ECG Monitoring using Artificial Intelligence

Peerbridge’s new AI-powered ECG patch "Cor" enables continuous, at-home heart monitoring, crucial for rural patients with limited hospital access.

Here's what to know about the device:

Remote Monitoring: Allows doctors to assess heart and sleep health from afar.
EF-ACT Trial: A 1,000-patient study across top health centers, assessing the device’s ability to measure Left Ventricular Ejection Fraction (LVEF), a key heart failure marker. Expected trial completion: five months.
FDA Clearance Strategy: Building on prior submissions and predicate devices, Peerbridge aims to secure FDA clearance for LVEF monitoring.

Building on Precedents: How Peerbridge is Navigating FDA Clearance

Peerbridge’s path to FDA clearance is paved with precedent, thanks to the groundwork laid by Anumana and, before that, Viz.ai. Peerbridge aims to bring an AI-powered ECG device to market, and by citing Anumana’s device as a predicate—which itself relied on Viz HCM’s De Novo clearance—Peerbridge can demonstrate substantial equivalence in its FDA submission. Here’s how this layered approach works:

Device Type and Regulatory Classification:

Viz HCM and Anumana’s devices both fall under Class II for cardiovascular AI-based software (21 CFR 870.2380), a category created to assess cardiovascular risk using machine learning and ECG data without giving definitive diagnoses. By aligning with this category, Peerbridge’s device is positioned as part of this new class of cardiovascular AI tools.

Clinical and Performance Standards:

Anumana set a high bar by following the clinical testing standards established by Viz HCM. These standards covered sensitivity, specificity, and performance across different demographic groups, which became benchmarks for subsequent AI-based devices. Peerbridge can now reference these proven testing protocols to establish its device's credibility and regulatory readiness.

Software as a Medical Device (SaMD):

Both Viz HCM and Anumana’s devices analyze ECG data as software solutions integrated within broader clinical systems, not as standalone hardware. Peerbridge can leverage this model, fitting smoothly into clinical workflows while reducing hardware dependencies.

Why It Matters

The De Novo clearance of Viz HCM not only set a regulatory precedent but also created a streamlined path for similar AI-driven diagnostics. By following Anumana’s approach, Peerbridge has a clearer path to FDA approval, as it can cite both Viz HCM and Anumana to meet FDA standards around intended use, technical alignment, and special controls for cardiovascular AI.

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