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Haemonetics (HAE) FDA Events

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FDA Events for Haemonetics (HAE)

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

Haemonetics' Drugs in FDA Review

SavvyWire® - FDA Regulatory Timeline and Events

SavvyWire® is a drug developed by Haemonetics for the following indication: Pre-Shaped Pressure Guidewire. 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.

VASCADE - FDA Regulatory Timeline and Events

VASCADE is a drug developed by Haemonetics for the following indication: Vascular closure. 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.

Haemonetics FDA Events - Frequently Asked Questions

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

In the past two years, Haemonetics (HAE) has reported FDA regulatory activity for the following drugs: VASCADE and SavvyWire®.

The most recent FDA-related event for Haemonetics occurred on August 15, 2024, involving VASCADE. The update was categorized as "Provided Update," with the company reporting: "Haemonetics Corporation announced the full market release of its VASCADE MVP® XL mid-bore venous closure system."

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

  • Vascular closure - VASCADE
  • Pre-Shaped Pressure Guidewire - SavvyWire®

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 (NYSE:HAE) was last updated on 7/10/2025 by MarketBeat.com Staff
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