FDA clears updated MONARCH Platform configuration
The FDA recorded a substantially equivalent decision for Auris Health's MONARCH Platform configuration MON-000008.
Evidence notes
- The applicant is Auris Health, Inc. at its Santa Clara operating address.
- The filing covers MONARCH Platform configuration MON-000008.
- The FDA decision date was 25 July 2026.
Company context
Auris Health develops the MONARCH robot-assisted endoscopy platform for bronchoscopic and urologic procedures. Johnson & Johnson acquired Auris in 2019, and the company remains part of Johnson & Johnson MedTech.