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
CLARITY and LIFEHAB. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
CLARITY FDA Regulatory Events
CLARITY is a drug developed by Aclarion for the following indication: 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:
- CLARITY
- Announced Date:
- September 25, 2025
- Indication:
- Chronic Low bAck pain
Announcement
Aclarion, Inc., announced that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled its first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery.
AI Summary
Aclarion, Inc. announced that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled the first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. This study will test whether Nociscan can improve outcomes for people having spine surgery for chronic low back pain.
The CLARITY trial will enroll 300 patients at leading U.S. centers and randomly assign surgeons to use Nociscan data or not. All participants receive an MRS scan before treatment. The main goal is to measure back pain change after 12 months, with other health and cost measures tracked as secondary endpoints. Internal interim results are expected in Q2 2026.
Nociscan combines MR Spectroscopy and augmented intelligence to detect chemical biomarkers linked to disc pain. Aclarion hopes this tool will become the gold standard for identifying pain sources, improve surgical planning, and demonstrate both clinical and economic value in spine surgery.
Read Announcement
LIFEHAB FDA Regulatory 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.
Read Announcement
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