NEW YORK CITY, NEW YORK / ACCESS Newswire / June 12, 2025 / Augnition Labs, a neurotechnology company developing science-driven tools to advance cognitive health, today announced that its flagship product, AugMem, has been classified by the FDA as a Prescription Use Cognitive Assessment Aid (PTY). This significant milestone paves the way for clinical deployment to support evaluation of cognitive function and help identify changes that may indicate early cognitive decline.
Grounded in more than two decades of neuroscientific research by Co-Founder and Chief Scientific Advisor, Dr. Michael Yassa, AugMem evaluates pattern separation - a core brain process that enables us to form distinct memories. Subtle impairments in this mechanism often precede clinical symptoms of cognitive decline by 10-15 years.
"Early detection is critical. If we wait until memory loss is obvious, decline can be irreversible," said Yassa. "This FDA classification is a major step forward. It opens the door for us to deploy it in healthcare settings. Our goal is to make ultrasensitive cognitive assessment available where it's needed most-at the frontlines of care, before symptoms become disabling."
In addition to this regulatory milestone, Augnition Labs also announced key leadership appointments to strengthen its path to growth and impact. Ernst Wodrada, a seasoned executive in the medical technology industry, has joined Augnition as President. Ernst brings leadership experience from global healthcare organizations, including Philips, where he led efforts in imaging, image-guided therapy, and healthcare innovation.
"I am honored and excited to join Augnition Labs, working alongside this fantastic team to forge meaningful partnerships with clinical experts and investors," Wodrada said. "Cognitive decline presents profound challenges, and together, we are committed to pioneering solutions that empower individuals and caregivers."
Ali Kennedy Scott, a member of Augnition's founding team, will step into the role of Managing Director. A former Bain & Company consultant, Kennedy Scott brings expertise in growth strategy, organizational effectiveness, and customer insight, with experience spanning healthcare, consumer products, and private equity-backed ventures.
The company also welcomes Dr. Chris Bun as Head of Technology. With a background in AI, machine learning, and healthcare technology, Dr. Bun will lead development of Augnition's core platform, applying advanced AI and user-centered design to cognitive assessment tools.
"We are deeply proud of the momentum behind AugMem and of this team that's come together to shape the future of cognitive assessments," said Kennedy Scott. "This FDA classification is a foundational step in our mission to equip patients, caregivers, and healthcare providers with tools that enhance clarity, agency, and hope."
Augnition collaborates with leading academic institutions, industry researchers, clinicians, and healthcare systems to create accessible, evidence-based tools for cognitive health.
About Augnition Labs
Augnition Labs develops science-driven tools to advance cognitive health. The company was founded on the scientific work of Dr. Michael Yassa, a globally recognized expert in the neurobiology of memory and Alzheimer's Disease. With a focus on clinical utility, human-centered design, and early intervention, Augnition empowers patients, researchers, and clinicians to better understand the brain and respond to change.
www.augnitionlabs.com
Contact Information
Ali Kennedy Scott
Managing Director
info@augnitionlabs.com
SOURCE: Augnition Labs
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/augnition-labs-announces-fda-classification-for-flagship-product-augm-1039092
