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Inari Medical (NARI) FDA Events

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FDA Events for Inari Medical (NARI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Inari Medical (NARI). Over the past two years, Inari Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as DM199 and FlowTriever®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Inari Medical's Drugs in FDA Review

DM199 - FDA Regulatory Timeline and Events

DM199 is a drug developed by Inari Medical for the following indication: Chronic Kidney Disease Stage II or III. 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.

FlowTriever® system - FDA Regulatory Timeline and Events

FlowTriever® system is a drug developed by Inari Medical for the following indication: For the non-surgical removal of clot from peripheral blood vessels, including for the use in the treatment of pulmonary embolism and clot in transit in the right atrium. 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.

Inari Medical FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Inari Medical (NARI) has reported FDA regulatory activity for the following drugs: DM199 and FlowTriever® system.

The most recent FDA-related event for Inari Medical occurred on February 20, 2025, involving DM199. The update was categorized as "Publication," with the company reporting: "DiaMedica Therapeutics Inc announced the peer-reviewed publication entitled:Recombinant human tissue kallikrein-1 for treating acute ischemic stroke and preventing recurrence (Kasner, et al.) which is now available online and is scheduled for print publication in the February 2025 issue of Stroke."

Current therapies from Inari Medical in review with the FDA target conditions such as:

  • Chronic Kidney Disease Stage II or III - DM199
  • For the non-surgical removal of clot from peripheral blood vessels, including for the use in the treatment of pulmonary embolism and clot in transit in the right atrium. - FlowTriever® system

More FDA Event Resources from MarketBeat

  • 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

This page (NASDAQ:NARI) was last updated on 7/10/2025 by MarketBeat.com Staff
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