DaTscan approved in the EU and US

The research record

This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".

Who

GE Healthcare (sponsor; the EMA page names GE Healthcare B.V., Eindhoven, as authorisation holder). Regulators: the European Commission, on the advice of the EMA's drug committee, and the US FDA. Funding of the pivotal studies was not read.

What happened

Fluorodopa PET had shown dopamine terminals in living brains in 1983 (landmark 274) but needs a cyclotron. Ioflupane binds the dopamine transporter, a protein on dopamine nerve endings, and is imaged by SPECT, a more widely available scanner.

• EU: marketing authorisation granted 27 July 2000 for an unlimited period; the EMA page (updated 25 Feb 2026) still lists it as authorised. Uses: detecting loss of dopamine nerve terminals in the striatum, to tell essential tremor from Parkinson-type syndromes in adults with unclear symptoms, and probable dementia with Lewy bodies from Alzheimer's.
• US: the label is revised 1/2011, "Initial U.S. Approval: 2011"; GE's announcement is dated 17 January 2011 and says the FDA acted after a Priority Review because of unmet clinical need. The indication is SPECT imaging of the striatal dopamine transporter to help evaluate adults with suspected parkinsonian syndromes, helping tell essential tremor from tremor due to Parkinson's, multiple system atrophy or progressive supranuclear palsy, as an adjunct to other tests. A 2022 expansion to suspected dementia with Lewy bodies is reported by GE (not read in full).
• FDA evidence: two single-arm studies in 284 adults with tremor (Study 1, 99 patients with early signs; Study 2, 185 with established diagnoses). A scan was abnormal in 77–79% of patients with a parkinsonian syndrome across three readers in Study 1, and 92–97% across five readers in Study 2. It was normal in 96% of those without one in Study 1, and 74–93% across five readers in Study 2.

Why it moved us toward a cure

It created the imaging data that regulators later used to endorse the scan for choosing trial participants (landmark 79). The scan measures dopamine terminals, not the disease cause.

Outcome

Advanced. The label states the scan cannot tell Parkinson's from multiple system atrophy or progressive supranuclear palsy, and that its use as a screening test or to monitor progression is not established.

Sources

• EMA, DaTSCAN product page (authorised 27 Jul 2000)
• EMA EPAR summary for the public
• FDA label, revised 1/2011
• GE Healthcare announcement, 17 Jan 2011 (Pharmaceutical Processing World)
• Not yet verified: the exact FDA approval day in January 2011 (the label PDF and GE's release do not give it); the pivotal European trials; any earlier national approvals. An 11-to-2 advisory panel vote reported earlier is removed (only trade press, not reread).