I see a lot of 510(k)s and de novos in the course of my work, so it is always inspiring to see something truly groundbreaking make it through the FDA. The recent de novo from Cardiosense announced last week met that bar.
Cardiosense’s Pulmonary Capillary Wedge Pressure (PCWP) Analysis Software de novo took a clever approach in first getting a non-invasive 510(k) cleared sensor that is worn on body, then using that 510(k) cleared device as part of the system in clinical trials to support the de novo for analysis software to estimate PCWP, pulmonary artery pressure and left ventricular end diastolic pressure.
Cardiosense’s approach is a well thought out strategy that I suggest to clients frequently with truly novel products. Companies should look at the long range goal of a product, and if it is feasible to split into separate components that could be separate submissions, that can enable your follow on submissions by reducing the overall complexity that an all-in-one, kitchen sink approach submission to FDA may entail. The added bonus is you have a 510(k) cleared product that is well understood by the FDA that you can use to generate clinical data for subsequent submissions, which is an enormous benefit.
This split component approach clearly paid off for Cardiosense. PCWP is typically measured intensive care / acute surgical settings with a Swan-Ganz catheter that is placed in the heart to measure PCWP, as well as other things such as pulmonary artery pressure and cardiac output. There are some implantable sensor technologies used to measure pulmonary artery pressure to manage patients with heart failure, but these involve invasive procedures to implant sensors in the heart. Considering all of this, getting a class II allowance for even the estimation of PCWP and pulmonary artery pressure in a non-invasive setting from the FDA is a huge win.
As is typical for things AI related going through the FDA, this de novo has the typical caveats of “intended to be used under the supervision of a qualified healthcare professional in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the qualified healthcare professional’s judgment” and “patient management decisions should not be made solely on the results of the PCWP Analysis Software.”
That said, Cardiosense’s estimation of PCWP, pulmonary artery pressure and left ventricular end diastolic pressure can help clinicians evaluate and manage patients for heart failure by a non-invasive means, which is significant. The de novo is limited to those with heart failure, which is appropriate, but the population numbers affected by varying stages of heart failure in the US are significant. It is always exciting to see something novel, which is a significant clinical achievement, successfully make it through the FDA process.
