BridgeSource Medical obtained a de novo clearance from the FDA for its handheld cardiac implant identifier, designed to help emergency department clinicians quickly identify the brand of hardware within a patient.
According to the Austin, Texas-based company, about half the time a patient enters the ER they don’t know, can’t communicate or aren’t carrying the wallet card listing the specific brand of their pacemaker or implanted defibrillator. This causes delays in triage and treatment — with different approaches being needed for each manufacturer — and clinicians often have to resort to an X-ray to determine the type of device.
BridgeSource’s SmartRead system can be used by frontline healthcare workers to identify an implant within 20 seconds. It works by mimicking the initial communication pings sent by the programming wands from each major implant manufacturer and waiting for a response, including devices from Abbott, Biotronik, Boston Scientific, Medtronic and MicroPort.
The system’s development was supported by small business grants from the NIH’s National Institute on Aging, including a recent $3 million in commercialization readiness funding, according to a LinkedIn post from BridgeSource’s co-founder, president and chief technology officer, John Porterfield.
Cardiac pacemakers and defibrillators have been implanted in more than 3 million people in the U.S., with about 40% age 70 or older, according to BridgeSource. At the same time, if they received the device at a different facility, the specific brand may not be listed in their medical record.
Additional delays in care have been linked to the need to contact a device manufacturer representative for guidance on treatment settings, especially when a patient arrives at the ER after business hours.
