4DMedical (ASX: 4DX) shares have been hotly covered over the past year.
4DMedical is a medical technology company working in the field of respiratory imaging and ventilation analysis. It operates in the treatment of lung and respiratory diseases.
The company's non-invasive lung imaging technology emanates from research work undertaken at Monash University.
The medical technology company rocketed more than 2,000% higher between April 2025 and April 2026.
However since reaching almost $7 per share, it has since fallen significantly and closed yesterday at $3.85.
A new report from Bell Potter indicates that it could be set to rebound close to these record highs. This comes after the company announced its plans for a post approval study.
Image source: Getty Images
What did the company announce?
4D Medical announced the launch of the CLEAR clinical study. The study is a major research program designed to demonstrate that its FDA-approved CT:VQ lung imaging technology can be used in patients with suspected pulmonary embolism (blood clots in the lungs).
The company will compare its CT:VQ scan directly against the current standard test. The current test requires patients to receive an injected contrast dye.
CT:VQ uses routine CT scans and software to assess airflow and blood flow in the lungs without the need for contrast dye.
CT:VQ already received FDA clearance in 2025. However that approval was based primarily on patients undergoing traditional nuclear medicine ventilation-perfusion scans.
The new CLEAR study is intended to generate evidence in the much larger population of patients.
4D Medical believes this is a significant commercial opportunity because around five million CTPA scans are performed each year in the United States for suspected pulmonary embolism, while only a small percentage of those scans ultimately confirm the disease.
If the CLEAR study shows CT:VQ can deliver comparable clinical outcomes, it could encourage hospitals and physicians to adopt CT:VQ more broadly as a contrast-free alternative.
In practical terms, 4D Medical is not seeking another FDA approval. Instead, it is conducting the CLEAR study to build the clinical evidence needed to drive adoption of CT:VQ in emergency and acute-care settings, potentially expanding its addressable U.S. market to around US$3 billion annually.
What is Bell Potter saying about 4DMedical shares?
The team at Bell Potter has increased its share price target to $6.00 (previously $4.50). This is largely due to optimism surrounding the CLEAR study.
The broker retained its speculative buy recommendation on 4DMedical shares.
Bell Potter said The CLEAR study is essential to accelerate adoption of CTVQ in front line emergency departments and for inpatient use.
4D Medical is not required to seek further FDA approval or a label expansion to the current 510K approval, however, the clinical data from the CLEAR study will provide the necessary evidence to further support broad adoption for diagnosis of PE. Outpatient reimbursement will continue under the existing category III CPTA codes paid at US$650/scan.
The new share price target indicates an upside potential of approximately 56% from current levels.
