Hogan Lovells Digital Health brochure 2024 - Flipbook - Page 9
Assisted CSD Labs in obtaining
510(k) clearance of eMurmur,
an innovative, AI-based murmur
detection software.
Assisted Digital Diagnostics to
achieve De Novo reclassification
from FDA for the groundbreaking
AI-based device IDx-DR, the first
device authorized for marketing
that autonomously analyzes
images of the retina for signs of
diabetic retinopathy, detecting
disease without the need for
a clinician to also interpret the
image or results.
Drafted formal comments and
achieved regulatory wins related
to healthcare AI in every major
CMS payment rule, including
the Medicare Physician Fee
Schedule, the Inpatient
Prospective Payment System,
and the Outpatient
Prospective Payment System.
Counseled clients on
advocacy and reimbursement
strategy and interactions
with reimbursement staff
and leadership at the U.S.
Department of Health & Human
Services Centers for Medicare
& Medicaid Services.
Advised a leading Asia-Pacific
headquartered technology
company on the commercialization
of its AI technologies through
a collaboration with a robotics
business.
Developed an innovative strategy
for interacting with FDA to allow our
client Viz.ai to gain a quick De Novo
clearance for a novel ComputerAided Triage and Notification
Platform to identify Large Vessel
Occlusion (LVO) strokes in CTA
imaging, meeting the
company’s tight deadlines.
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