Indica Labs has secured the US Food and Drug Administration (FDA) 510(k) clearance for its enterprise digital pathology platform dubbed HALO AP Dx.
The New Mexico-based digital pathology solutions provider has designed the HALO AP Dx for primary diagnosis, collaboration, tumour boards, and second opinions.
The 510(k) clearance will enable HALO AP Dx to be used with the Hamamatsu NanoZoomer S360MD Slide scanner for in-vitro diagnostic applications.
It will also allow the digital pathology platform to be used with other FDA-cleared slide scanners in the future.
HALO AP Dx is based on the HALO AP platform that is used globally to analyse, manage, and utilise digital pathology images.
According to Indica Labs, both platforms have a comprehensive suite of diagnostic tools and features for streamlined and precise image assessment, management, and collaborative efforts.
In the US, Indica Labs will continue offering HALO AP for Research Use Only (RUO) applications and will launch HALO AP Dx for primary diagnosis purposes.
Indica Labs founder and CEO Steven Hashagen said: “Indica Labs is dedicated to improving patient care by providing an ideal environment for the practice of pathology that supports both current and future technologies, ensuring pathologists have the best tools available at their fingertips and are prepared for whatever the future of digital pathology holds.”
HALO AP Dx’s interoperability can allow users to tailor the platform to suit their requirements and integrate it into their current laboratory workflows.
Indica Labs said that the integration will create a custom-built digital pathology environment, accommodating a variety of pathologic specialties, including those with distinctive technical needs.
Additionally, HALO AP Dx offers flexibility for deployment in either a cloud-based or on-premises environment, giving users the autonomy to choose their preferred data storage method.
The digital pathology platform also facilitates remote work and consultations, features that are important due to the growing shortage of pathologists and increasing case volumes.
Furthermore, the platform enables pathology labs to maintain uninterrupted services by granting access to slides for review from any location. This supports round-the-clock global collaboration without the need to physically ship slides.
HALO AP has received CE-IVDR marking for in-vitro diagnostic applications in Europe, the UK, and Switzerland.
