“For too long, testing in decentralized settings has been fragmented across multiple instruments,” said Richard West, Founder and CEO of Baebies. “This clearance expands our opportunity in urgent care and other near-patient settings, and builds an installed base that can support our expanding menu of multifunctional assays. This milestone reflects the extraordinary work of our team and creates a scalable path to new revenue opportunities as additional tests are introduced.”

Powered by digital microfluidics, FINDER combines ultra-rapid PCR with integrated sample preparation in a fully enclosed cartridge. Beyond this launch, Baebies is advancing a broader molecular menu spanning high-plex panels for pathogens detected from blood, urine, nasal and vaginal swabs, host-response transcriptomic assays, and quantitative PCR programs for HIV and HCV. That roadmap positions FINDER not simply as a fast PCR system, but as a more capable molecular platform built for real-world near-patient testing.