FDA Issues Warning Letter to APAP Maker Over Unapproved Design Changes

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FRIDAY

JULY 24, 2026

Main Story

FDA-Cites-BMC-Medical-Unapproved-G3X-APAP-Design-Changes-to-Luna-Line-

FDA Cites BMC Medical Over Unapproved G3X APAP

FDA warning letters identify unapproved device modifications, algorithm changes, and reporting deficiencies affecting BMC Medical's G3X APAP and Luna product line, raising important regulatory, clinical, and patient safety considerations for sleep medicine professionals.

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