Inspire Medical Systems (INSP) FDA Approvals $50.28 +0.26 (+0.52%) Closing price 03:59 PM EasternExtended Trading$50.16 -0.13 (-0.25%) As of 07:44 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Inspire Medical Systems' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Inspire Medical Systems (INSP). Over the past two years, Inspire Medical Systems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Inspire. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Inspire V FDA Regulatory Events Inspire V is a drug developed by Inspire Medical Systems for the following indication: for patients with obstructive sleep apnea (OSA). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Outcome - October 10,2025Outcome Drug: Inspire VAnnounced Date: October 10, 2025Indication: for patients with obstructive sleep apnea (OSA)AnnouncementInspire Medical Systems, Inc. today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company's limited market release in the United States including single site experience at two leading centers.AI SummaryInspire Medical Systems, Inc. published clinical outcomes for its new Inspire V system from a Singapore study and a limited U.S. market release at leading centers. In Singapore, 44 patients were followed for six months after implantation. Surgeons cut implant times by 20% compared to the previous model, and all procedures succeeded. Internal respiratory sensing removed the need for external leads, and the device achieved 87% inspiratory phase overlap versus 79% with the older system. Patients averaged 5.5 hours per night on therapy, and their average apnea-hypopnea index dropped from 34 to 8 events per hour. Safety was strong, with only two minor infections. In the U.S., 101 patients at ten centers completed implants without serious issues. At 60 days, patients used the device 6.8 hours nightly at 1.7 volts. Preliminary sleep studies on 34 patients showed AHI cut from 30 to 4.5 events per hour. Single-site data from Boston and Colorado confirm shorter procedure times and higher surgery volume.Read Announcement Inspire Medical Systems FDA Events - Frequently Asked Questions Has Inspire Medical Systems received FDA approval? As of now, Inspire Medical Systems (INSP) has not received any FDA approvals for its therapy in the last two years. What drugs has Inspire Medical Systems submitted to the FDA? In the past two years, Inspire Medical Systems (INSP) has reported FDA regulatory activity for Inspire V. What is the most recent FDA event for Inspire Medical Systems? The most recent FDA-related event for Inspire Medical Systems occurred on October 10, 2025, involving Inspire V. The update was categorized as "Outcome," with the company reporting: "Inspire Medical Systems, Inc. today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company's limited market release in the United States including single site experience at two leading centers." What conditions do Inspire Medical Systems' current drugs treat? Currently, Inspire Medical Systems has one therapy (Inspire V) targeting the following condition: for patients with obstructive sleep apnea (OSA). More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events ClearPoint Neuro FDA EventsMoleculin Biotech FDA EventsAprea Therapeutics FDA EventsCapricor Therapeutics FDA EventsCelcuity FDA EventsCytokinetics FDA EventsEyepoint Pharmaceuticals FDA EventsKaryopharm Therapeutics FDA EventsMIRA Pharmaceuticals FDA EventsSavara FDA EventsTvardi Therapeutics FDA EventsAbbVie FDA EventsJohnson & Johnson FDA EventsPfizer FDA EventsAllogene Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies MiniMed Group FDA Events TransMedics Group FDA Events AxoGen FDA Events Pulse Biosciences FDA Events NovoCure FDA Events Artivion FDA Events Alpha Tau Medical FDA Events Bioventus FDA Events PROCEPT BioRobotics FDA Events Spyglass Pharma FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NYSE:INSP last updated on 10/10/2025 by MarketBeat.com Staff. 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Outcome - October 10,2025Outcome Drug: Inspire VAnnounced Date: October 10, 2025Indication: for patients with obstructive sleep apnea (OSA)AnnouncementInspire Medical Systems, Inc. today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company's limited market release in the United States including single site experience at two leading centers.AI SummaryInspire Medical Systems, Inc. published clinical outcomes for its new Inspire V system from a Singapore study and a limited U.S. market release at leading centers. In Singapore, 44 patients were followed for six months after implantation. Surgeons cut implant times by 20% compared to the previous model, and all procedures succeeded. Internal respiratory sensing removed the need for external leads, and the device achieved 87% inspiratory phase overlap versus 79% with the older system. Patients averaged 5.5 hours per night on therapy, and their average apnea-hypopnea index dropped from 34 to 8 events per hour. Safety was strong, with only two minor infections. In the U.S., 101 patients at ten centers completed implants without serious issues. At 60 days, patients used the device 6.8 hours nightly at 1.7 volts. Preliminary sleep studies on 34 patients showed AHI cut from 30 to 4.5 events per hour. Single-site data from Boston and Colorado confirm shorter procedure times and higher surgery volume.Read Announcement
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