Cancer informatics and digital pathology provider Inspirata announced today that pandemic-related regulatory flexibilities issued by the U.S. Food and Drug Administration (FDA) may enable Inspirata’s digital pathology solution, Dynamyx, along with other digital pathology components to be used for primary diagnosis in perpetuity, without the need for 510(k) premarket notification.
In early 2020, as a response to the COVID-19 pandemic, the FDA and CMS announced temporary waivers of 510(k) requirements and CLIA licensing requirements respectively. This was meant to promote the remote viewing and reporting of whole slide images (WSIs). In a time of increasing need to socially distance, the temporary waiver allowed pathologists to work and diagnose patients remotely, often from the safety of their homes.
While Inspirata has been in the process of obtaining 510(k) clearance from the FDA, the temporary waiver has allowed Dynamyx to be used for primary diagnosis since the waiver’s issuance in 2020. However, the newly proposed permanent waiver would allow Dynamyx to be used for primary diagnosis in perpetuity without the need of a 510(k).
The new regulatory determination is driven by the low number of adverse events registered by several medical devices in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database over the last 10 years. In fact, Digital Pathology Image Viewing and Management Software registered zero adverse effects during that time.
The pandemic presented a unique opportunity for the FDA to evaluate adverse events prior to and during this public health emergency. Because the experiences with digital pathology have been so positive across both periods, the FDA has determined that premarket notification was not providing additional safety and efficacy benefits. Therefore, the FDA’s January 15th notification is a proposal that the regulatory flexibilities be made permanent.
“We’re pleased that the FDA is in favor of relaxing the premarket notification regulation. We expect to see a much higher and faster adoption of digital technology across practitioners at all types of pathology labs,” said Mark Lloyd, Inspirata’s Executive Vice President and Founder. “With less regulation, the government is agreeing that digital pathology is more comparable to the traditional microscope and glass in terms of safety and efficacy. This is a great attestation of the maturity that digital pathology has reached.”
About Inspirata:
Inspirata, Inc. helps patients fighting cancer—and the clinicians they trust—to make every moment matter. Our comprehensive cancer informatics solutions bring disparate data together throughout the entire cancer care journey to drive informed decisions that improve survivorship.
Inspirata has assembled the most advanced and proven technologies to address the complex challenges of delivering cancer care and conducting ground-breaking research. We combine leading digital pathology solutions with automated cancer registry solutions, comprehensive cancer informatics and advanced patient engagement tools to bring users the broadest oncology informatics platform available globally. To learn more, visit www.inspirata.com.
Inspirata Contact:
Emil Mladenov
Vice President of Corporate and Digital Marketing
E-mail: emladenov@inspirata.com
Tel: +1-813-467-7616