Great pickup - yes indeed, inpatient admission for drug initiation has been the standard for too long (30 years to be precise). We use the standard Fridericia formula preferred for assessing drug risk, but we also use Bazett correction for algorithm validation as it is used more often clinically
Love these cardiology-specific questions! Low risk would indeed be based on the history, labwork (e.g. renal function), baseline ECG including HR, and EF
Great question, by detecting and alerting the earliest ECG changes that are well-validated risk factors for sudden cardiac death, we can prevent these deaths and get the patient the care they need
Sorry to hear about your kid, SVTs can be tough. May be worth asking your pediatrician about other options for monitoring that are suited for pediatric use!
Thanks so much, yes we agree - patients have hated being hospitalized to start pills long before COVID! But now, as you point out, there is even more urgency to treat people safely at home.
Thank you so much! Our patient interface guides them through how to hold the device, it's a very simple device so even our 90 year old patients love using them :)
Awesome, yeah we mentioned it briefly but heart rhythm side effects are a problem for so 300+ drugs - antibiotics, pain meds, psychiatric meds. The list goes on!
Yes, you get it - it's a boring hospitalization all around! For patients getting a cardioversion after their drug-load, they can fortunately come get one as an outpatient (most cardioversions are for elective outpatients, and in fact the inpatients often get bumped for the scheduled outpatients). Hospitals are particularly happy about our workflow because they don't get dinged for readmissions - whether for cardioversions or for drug dose adjustments, which also require readmission under the current standard.
Phase I Software validation doesn't require clinicaltrials.gov registration, but our Phase II trial will be per FDA!
So true, and a revealing insight into US healthcare! The vast majority actually goes toward hospital room and board, with a fraction of the cost for the ECG monitoring. This is why insurers are keen to reimburse an out-of-hospital alternative
Thank you so much for sharing your personal experience. Best wishes for a speedy recovery for your mother - this is unfortunately a common theme among our patients and we're excited to make a big change here. Let your mother know that we're pulling for her!
Great point, indeed the problem of automated ECG analysis has been around for the last several decades and there's still no automated solution accurate for AFib patients (one of the the hardest categories for making ECG measurements). Our software is specifically trained on AFib ECGs and our specific focus of this market and guiding drug dosing, as well as our clinical expertise in the field gives us our edge. It's a similar reason why startups can do things that Google and Amazon can't :)
Thanks so much! Medicine is often a mix of extremely high tech and very low tech, so we're in a great position to fix the latter :) We can actually pair with multiple different types of hardware (our software is hardware-agnostic) but we have a couple preferred hardware devices. One of which is https://www.kardia.com/kardiamobile6l/
Great question, our training data involves thousands of ECGs to validate the software performance of the algorithm itself. As far as in-human data, 100 patients is well-powered for Phase I software validation, in preparation for our upcoming prospective clinical trial (Phase II). These results are hot off the press so we don't have a public link yet - more to come!