FDA Events for Aclarion (ACON)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Aclarion (ACON).
Over the past two years, Aclarion has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LIFEHAB. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LIFEHAB - FDA Regulatory Timeline and Events
LIFEHAB is a drug developed by Aclarion for the following indication: For Chronic Low Back Pain.
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:
- LIFEHAB
- Announced Date:
- September 10, 2024
- Indication:
- For Chronic Low Back Pain
Announcement
Aclarion announced the completion of the first Nociscan exams for patients enrolled in the LIFEHAB Trial in Norway.
AI Summary
Aclarion recently announced that the initial patients in Norway’s LIFEHAB Trial have completed their first Nociscan exams. The LIFEHAB Trial is studying 202 patients with chronic low back pain that has lasted more than one year, comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation. The Nociscan exams use magnetic resonance spectroscopy (MRS) biomarkers to evaluate patient improvement following treatment and help physicians determine which discs may be the source of pain.
This achievement marks an important step in understanding how these biomarkers can guide treatment decisions. The exams, completed by six patients starting in late August 2024, support the goal of using Nociscan to select optimal treatment options for chronic low back pain. Aclarion expects that the trial’s results will further validate Nociscan as a key tool in clinical research and treatment planning.
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Aclarion FDA Events - Frequently Asked Questions
As of now, Aclarion (ACON) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Aclarion (ACON) has reported FDA regulatory activity for LIFEHAB.
The most recent FDA-related event for Aclarion occurred on September 10, 2024, involving LIFEHAB. The update was categorized as "Enrollment Update," with the company reporting: "Aclarion announced the completion of the first Nociscan exams for patients enrolled in the LIFEHAB Trial in Norway."
Currently, Aclarion has one therapy (LIFEHAB) targeting the following condition: For Chronic Low Back Pain.
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:ACON) was last updated on 7/9/2025 by MarketBeat.com Staff
