FDA Events for Nuwellis (NUWE)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Nuwellis (NUWE).
Over the past two years, Nuwellis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Aquadex. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Aquadex SmartFlow® - FDA Regulatory Timeline and Events
Aquadex SmartFlow® is a drug developed by Nuwellis for the following indication: For patients suffering from hypervolemia (fluid overload).
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.
- Drug:
- Aquadex SmartFlow®
- Announced Date:
- August 27, 2024
- Indication:
- For patients suffering from hypervolemia (fluid overload).
Announcement
Nuwellis, Inc. is pleased to announce the publication of a new study in Current Problems in Cardiology demonstrating the effectiveness of Aquadex® ultrafiltration therapy in reducing 60 day hospital readmission rates for patients with acutely decompensated heart failure (ADHF) who are otherwise resistant to diuretic treatment.
AI Summary
Nuwellis, Inc. announced a new study published in Current Problems in Cardiology that shows Aquadex® ultrafiltration therapy effectively reduces 60-day hospital readmission rates for patients with acutely decompensated heart failure (ADHF) who do not respond well to diuretic treatment. The study, conducted in a community hospital setting, involved 30 patients and focused on evaluating whether the Aquadex therapy could lower the high rehospitalization rates often seen in these patients.
Key findings revealed that the therapy led to significant volume loss and weight reduction without harming renal function. Importantly, patients experienced a drop in heart failure readmissions, with rates falling from 26.7% before treatment to 16.7% after therapy initiation. This research supports Aquadex ultrafiltration as a promising treatment option for managing fluid overload in ADHF patients resistant to standard diuretic therapies.
Read Announcement
Nuwellis FDA Events - Frequently Asked Questions
As of now, Nuwellis (NUWE) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Nuwellis (NUWE) has reported FDA regulatory activity for Aquadex SmartFlow®.
The most recent FDA-related event for Nuwellis occurred on August 27, 2024, involving Aquadex SmartFlow®. The update was categorized as "Publication," with the company reporting: "Nuwellis, Inc. is pleased to announce the publication of a new study in Current Problems in Cardiology demonstrating the effectiveness of Aquadex® ultrafiltration therapy in reducing 60 day hospital readmission rates for patients with acutely decompensated heart failure (ADHF) who are otherwise resistant to diuretic treatment."
Currently, Nuwellis has one therapy (Aquadex SmartFlow®) targeting the following condition: For patients suffering from hypervolemia (fluid overload)..
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:NUWE) was last updated on 7/11/2025 by MarketBeat.com Staff
