FDA granted BridgeSource Medical a De Novo for SmartRead, a handheld unit that tells emergency department staff who made the pacemaker or defibrillator already in a patient's chest. Co-founder and CTO John Porterfield disclosed the decision in a LinkedIn post on October 8.
SmartRead imitates the opening signal each manufacturer's programming wand sends, then waits for the implant to answer. It covers Abbott, Biotronik, Boston Scientific, Medtronic and MicroPort hardware, and returns a brand in about 20 seconds.
The company says that roughly half the time a patient reaches the ER, nobody can confirm the device. The patient cannot communicate, does not know, or never carried a wallet card. Staff then work through wands by trial and error while triage waits.
NIH paid for most of this. Two Phase II awards funded the triage identifier, $1.5M in 2019 and $2M in 2023, with a recent $3M commercialization readiness grant from the National Institute on Aging on top. A De Novo also creates the regulation and the product code, so the next company into this niche files a 510(k) against a five-person shop in Austin.