BRIDGEWATER, N.J., May 22, 2024
/PRNewswire/ -- Indica Labs, an
industry leader in AI-powered digital pathology solutions, and
Hamamatsu Photonics K.K., a pioneer in whole slide imaging systems,
announce that the U.S. Food and Drug Administration (FDA) has
issued a 510(k) clearance to Indica
Labs for HALO AP Dx, an enterprise digital pathology
platform. HALO AP Dx is indicated for primary diagnosis of surgical
pathology slides prepared from formalin-fixed paraffin embedded
(FFPE) tissue scanned by the NanoZoomer® S360MD Slide
scanner1. This 510(k) clearance from the FDA expands on
an established partnership between Indica
Labs and Hamamatsu Photonics K.K.
Steven Hashagen, founder and CEO
of Indica Labs said, "This FDA
clearance for primary diagnosis of surgical pathology slides
prepared from FFPE tissue is a significant milestone for HALO AP Dx
that builds upon our prior CE-IVDR certification for HALO AP®.
We're proud that our collaboration with Hamamatsu allowed us to
leverage images from their NanoZoomer Slide scanner and led
directly to this landmark achievement that will provide value to
patients and healthcare providers alike."
HALO AP® is a case-centric digital pathology platform that is
deployed worldwide and has transformed the way pathologists and
researchers analyze, manage, and utilize digital pathology images
through its comprehensive suite of tools and features for efficient
and accurate image evaluation, management, and collaboration. HALO
AP® and Hamamatsu NanoZoomer Slide scanners are already in use
together at a variety of institutions and centers in the US for
research purposes, and in the EU and the UK for clinical
applications. In the US, Indica Labs
will continue to offer HALO AP® for Research Use Only applications,
and will now also offer HALO AP Dx for primary diagnosis of
surgical pathology slides prepared from FFPE tissue.
The NanoZoomer® S360MD Slide scanner system is an expertly
crafted digital pathology solution that displays images and
provides image management tools and aids qualified pathologists in
the review and interpretation of digital images of surgical
pathology slides prepared from FFPE tissue.
Fumio Iwase, Executive Officer,
Division Director, Systems Division at Hamamatsu Photonics K.K.
said, "We believe that comprehensive tools are key to the
advancement of digital pathology. The 510(k) clearance of the
Indica Labs HALO AP Dx for review of images acquired with the
previously 510(k)-cleared NanoZoomer® S360MD Slide scanner system
is a testament to the unwavering quality and confidence that both
partners consistently deliver to our valued customers. This
regulatory achievement represents a significant stride forward,
underscoring our joint commitment to providing cutting-edge
solutions that elevate standards in the digital pathology field and
empower professionals in their diagnostic endeavors."
1HALO AP Dx (K232833) is FDA-cleared for primary
diagnostic use with the Hamamatsu NanoZoomer® S360MD Slide scanner
in the US. In addition, HALO AP Dx provides built-in compliance and
certifications with FDA 21 CFR Part 11 and HIPAA.
HALO AP® is CE-IVDR marked for in-vitro diagnostic use in
Europe, the UK, and Switzerland. HALO AP is For Research Use Only
in the US and is not FDA cleared for clinical diagnostic use. In
addition, HALO AP provides built-in compliance and certifications
with FDA 21 CFR Part 11, HIPAA, and GDPR.
About Indica
Labs
Indica Labs is
the world's leading provider of AI-powered digital pathology
software and services. Our flagship HALO® and HALO AI platform
powers quantitative evaluation of digital pathology images. HALO
Link facilitates research-focused image management and
collaboration while HALO AP® and HALO AP Dx deliver enterprise
digital pathology for primary diagnosis with regulatory clearances
in multiple markets. Through a commitment to open pathology and a
combination of performance, scalability, and usability, our
software solutions enable pharma companies, diagnostic labs,
hospitals, research organizations, and Indica's own contract Pharma
Services team to advance tissue-based research, clinical trials,
and diagnostics.
About Hamamatsu Corporation
Hamamatsu Corporation is
the North American subsidiary of Hamamatsu Photonics K.K.
(Japan), a leading manufacturer of
devices for the generation and measurement of infrared, visible,
and ultraviolet light. These devices include photodiodes, silicon
photomultipliers, photomultiplier tubes, scientific light sources,
infrared detectors, image sensors, spectrometers, and cameras. The
parent company is dedicated to the advancement of photonics through
extensive research. This corporate philosophy results in
state-of-the-art products which are used throughout the world in
scientific, industrial, and commercial applications.
Information furnished by Hamamatsu Corporation is believed to be
reliable. However, no responsibility is assumed for possible
inaccuracies or omissions. Specifications are subject to change
without notice.
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SOURCE Hamamatsu Corporation