---
schema_version: "secwatch.filing_event.v1"
accession: "0001609550-24-000036"
form_type: "8-K"
ticker: "INSP"
cik: "0001609550"
company_name: "Inspire Medical Systems, Inc."
filed_at: "2024-08-02T23:59:59+00:00"
generated_at: "2026-05-31T13:28:09.896043+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Inspire Medical receives FDA approval for next-gen Inspire V neurostimulation system

## Summary
- FDA approved Inspire V system including next-generation neurostimulator, Bluetooth patient remote, and physician programmer.
- Targets soft launch in late 2024 and full commercial launch in 2025.
- Company focusing on operational readiness: product manufacturing and inventory levels for U.S. launch.
- CEO cites FDA approval as a key milestone for Inspire therapy.

## SEC filing metadata
- accession: 0001609550-24-000036
- form_type: 8-K
- ticker: INSP
- cik: 0001609550
- company_name: Inspire Medical Systems, Inc.
- filed_at: 2024-08-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1609550/000160955024000036/0001609550-24-000036-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1609550/000160955024000036/insp-20240802.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001609550-24-000036
- JSON: https://secwatch.observer/filing/0001609550-24-000036.json
- Plain text: https://secwatch.observer/filing/0001609550-24-000036.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.