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THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

Breakthrough

Pattern Bioscience takes a second Breakthrough designation, this one for a same-day urine susceptibility panel

MedDevice Startups Staff · 2 days ago · 2 min read · Via Business Wire

FDA granted Pattern Bioscience a Breakthrough Device designation for its Urine ID/AST Panel on September 21. The Austin company already holds one for its Pneumonia ID/AST Panel.

The panel identifies and quantifies organisms straight from a urine specimen, then reports antimicrobial susceptibility from the same run. Pattern uses a single-cell microbiology platform instead of overnight culture, which turns a two to three day answer into hours. CEO Carey-Ann Burnham put the case in workload terms: urine is the highest volume specimen in the clinical microbiology lab, UTI is a common route to sepsis, and UTIs drive a large share of antibiotic use.

Both panels are investigational use only with no FDA clearance. A Breakthrough designation buys interaction with reviewers and priority handling, not a market. For a diagnostics startup the real value is agreeing a trial design with FDA before spending the money on it.

Questions & Answers

What is the Pattern Bioscience Urine ID/AST Panel?

It identifies and quantifies organisms directly from a urine specimen and reports antimicrobial susceptibility on the same platform. Pattern Bioscience returns results the same day rather than the two to three days conventional culture takes.

Is the Pattern Bioscience Urine ID/AST Panel cleared by FDA?

No. As of the Breakthrough Device designation on September 21, 2026, Pattern Bioscience products remain investigational use only and are not FDA cleared.

How many Breakthrough designations does Pattern Bioscience hold?

Two. FDA designated the Austin company's Pneumonia ID/AST Panel first, then granted the Urine ID/AST Panel designation on September 21, 2026.

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