Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) said the US regulator accepted its recent new drug application as a complete response to issues raised in a letter following the initial submission.
Investors were told the Food & Drug Administration had set a user fee goal date, effectively a deadline to assess the application, of September 30.
Polarean chief executive, Richard Hullihen, said: "We are happy that the FDA has accepted our resubmission and look forward to resuming the review process with them in the expanded context of our response."
The group has developed equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging using hyperpolarised xenon gas.