FDA clears Apple Watch-integrated Parkinson’s monitoring tool from Kneu Health

About:

• The FDA has cleared a new Apple Watch-based tool for tracking Parkinson’s symptoms for clinical use.

• The tool, designed by Kneu Health, provides 24/7 passive measurement of tremor, complementing the FDA-cleared rest and postural tremor already captured through active tests in Kneu's smartphone app. It also measures dyskinesia for the first time.

• Also approved for clinical use in the UK, the tool supports patients and clinical teams to build a clear picture of disease progression between appointments, with the aim of improving care and helping anticipate necessary changes to medication.

New York, September 3, 2026 - The US Food and Drug Administration (FDA) has cleared a new Apple Watch-based monitoring tool for Parkinson’s symptoms for clinical use in the US.

Designed by Kneu Health, a digital neurology platform for Parkinson’s disease and dementia, the new passive monitoring tool is deployed via Apple Watch, enabling 24/7 monitoring of tremor symptoms as well as tracking of dyskinesia, the involuntary movements that can occur as a side effect of Parkinson's medication.

For people with Parkinson's disease, symptoms can fluctuate throughout the day and across weeks, and a clinic appointment captures only a moment in time, not the full story. With the FDA clearance of Kneu’s new tool, continuous longitudinal measurement runs alongside multimodal active monitoring, allowing clinicians to see how symptoms change over time, rather than how they appear at a single clinic visit.

Building a continuous picture

The active testing patients already complete via Kneu’s smartphone app, including motor and cognitive assessments, now runs alongside passive data collected from a patient’s own Apple Watch. This gives clinicians and patients a clearer overview of Parkinson's symptoms and response to medication, enabling dynamic decision-making and improved condition management.

One UK-based clinician whose patients are using Kneu’s tools said: “One of my patients shared with me that before using the Kneu app, he was feeling hopeless and was struggling with his Parkinson's diagnosis. Since using the app, it’s given him hope and completely changed the way he views his disease. He’s been able to see that he’s actually more stable than he thought and that he’s doing better in certain areas than he anticipated. It's given him back a sense of control.”

Live across the UK

The app and Apple Watch tools are also registered with the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK and are already live across ten National Health Service (NHS) organisations.

Dr Kinan Muhammed, Co-Founder and Chief Medical Officer at Kneu Health, and consultant neurologist said: "The challenge isn't collecting more data, it's understanding what it means for each patient. By combining continuous passive monitoring from Apple Watch with our existing active smartphone assessments, we're helping patients and clinicians recognise changes earlier, make more personalised treatment decisions, and bridge the gap between life at home and care in the clinic."

Within two weeks of introducing the new monitoring tool in the UK, 79% of eligible patients had already chosen to adopt it.

“Pairing the watch was easy, I had no problems with it,” commented a patient who is already using the tool. “The extra information is helpful, it's nice to have it all in one place. The more data my clinician can get the better.”

Reducing burden as demand rises

Parkinson’s is the fastest-growing neurological disease worldwide, and the burden on pressured teams and clinicians will only continue to grow.

Caroline Cake, Co-Founder and CEO of Kneu Health, said: “Parkinson’s doesn’t stop between appointments, and neither should measurement. By capturing passive data from watches alongside active assessments, clinical teams can get a clearer picture of how someone is doing in everyday life. This can help teams spot changes earlier, understand their patients at scale, and focus their time where it’s needed most.”

Kneu Health

Kneu Health is pioneering continuous intelligence for neurological care through monitoring of Parkinson's and dementia. Built on Oxford University's decade-long longitudinal research and validated across leading health systems, the company's FDA-cleared platform transforms daily interactions into clinical insights that enable earlier intervention and personalised care. Backed by Oxford Science Enterprises, Cedars-Sinai, and a global syndicate of investors, Kneu operates across ten NHS Trusts and flagship U.S. health systems. Learn more at kneu.com.

Media contact

For interviews or further information, please contact media@kneu.com