Hyperfine Investor Presentation Deck
Regulatory Excellence: Success in Multiple Geographies
USA
2020
The Swoop system
is cleared for brain
imaging of patients
of all ages.
Eight FDA clearances
since 2020.
Most recently cleared
under K230208.
*Not yet commercialized
13
European Union*
2023
The Swoop system
has CE certification for
the European Union.
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United Kingdom*
2022
The Swoop system
has UKCA certification for
the United Kingdom.
KM
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Canada
2021
The Swoop system
is approved for commercial
sale in Canada. (Health
Canada License 107054)
NZ
ZN
Broad indi tion for imaging of the brain.
Eight FDA clearances for the Swoop system in the last 36 months.
CE certification achieved under latest MDR regulations.
Australia
2022
The Swoop system
is approved for commercial
sale in Australia. (TGA
ARTG Identifier 384545)
NZ
ZN
New Zealand
2022
The Swoop system
notified to WAND
database and available
for commercial sale in
New Zealand.
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