biotricity has an fda approval using cardiocomms software.it has a market cap of about 96 million with no sales to date. The most recent advancement in cardiac monitoring is Continual Mobile Cardiac Telemetry (MCT), consisting of around-the-clock patient heart monitoring through small unobtrusive leads on the chest and a small, phone-like device that the patient carries with them. The device transmits the data via cell signal to remote monitoring centers, or can be periodically dumped or sent back to a data center. The MCT space has grown with improved technology, similar to wearables, and doctors are increasingly turning to simple Remote devices as opposed to older, bulkier devices that require a carrying case. Smaller upstarts have been huge beneficiaries. Biotelemetry's (BEAT) sole focus is remote cardiac monitoring, and since re-positioning the business a few years ago, is now doing $287 million in revenue from their cardiac monitoring services business. The company is valued at $1.1 billion in market capitalization, and has climbed from $2.50 to $35 in just five years - a 1300% return.
IRhythym (IRTC) did $99 million last year with their sole product, the Zio Device, just two years since their IPO. IRTC is up almost 200% and is loved by Wall Street, with a $1.2 billion valuation based on the growth opportunity in cardiac monitoring.
Biotricity (BTCY) just received FDA clearance for their first proprietary Mobile Cardiac Telemetry (MCT) system, called Bioflux MCT, making this only one of a handful of cleared mobile monitoring devices. regarding fda...
The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days. FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI request. MDUFA Decisions for 510(k) submissions include findings of substantially equivalent (SE) or not substantially equivalent (NSE).