Powerful Medical today announced FDA De Novo authorization for its Queen of Hearts AI ECG model.
According to New York–based Powerful Medical, the AI-powered model is meant to identify ECG findings suggestive of urgent acute coronary syndrome (ACS). The goal is to get urgent notifications to clinicians of suspected cases. According to Powerful Medical, the FDA nod for Queen of Hearts is accelerating U.S. deployment of PMcardio — an AI-driven cardiac care coordination platform built for health system.
“This milestone reflects our mission to ensure every patient has access to fast, accurate heart attack diagnosis, regardless of where they present,” Powerful Medical CEO Martin Herman said in a news release. “With FDA De Novo authorization in place, we can scale adoption and bring this technology into routine clinical care across the United States.”
The Powerful Medical news is just one of the medtech stories that have caught our eye over at MassDevice in recent days. Other recent medtech news came from Implicity, Transmedics, and Edwards Lifesciences. Stories included:
- Cambridge, Massachusetts–based Implicity secured $40 million in growth equity funding to scale its AI-driven cardiac monitoring platform globally. European tech growth capital firm IRIS, alongside Five Arrows, the alternative assets arm of Rothschild & Co. led the round.
- Donor organ transport tech company TransMedics (Nasdaq: TMDX) is bringing in Fernando Araujo, who has held financial executive roles at GE HealthCare and 3M, as its new CFO, effective Sept. 21. Andover, Massachusetts–based TransMedics says its present CFO Gerardo Hernandez will transition into a Latin America commercial strategic advisor role.
- Edwards Lifesciences (NYSE: EW) operations in Limerick and Shannon, Ireland have won the company’s global Plant of the Year award for the second year in a row, according to the Limerick Post.
