FDA Registration & U.S. Commercial Launch of Pixie Scientific’s Smart Pads for Monitoring Urinary Tract Infections in Incontinent Seniors

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Scott Meek, Ph.D, head of research and development at Pixie Scientific reports, “We started Pixie Scientific with a big idea—to unobtrusively monitor health conditions.  To see our first product achieve registration with the FDA and begin shipping to our Early Access customers is truly amazing.  No other technology platform is focused on meeting the significant unmet need of UTI monitoring in seniors.”

Pixie Scientific announced today that it has completed the FDA registration for Pixie Smart Pads and has begun shipping to Early Access customers.  The company states that the Class I medical device utilizes a patented sensor and software platform to unobtrusively monitor incontinent seniors for an analyte commonly associated with urinary tract infections (UTIs).

Pixie Scientific is a healthcare platform technology company that focuses on improving outcomes by connecting populations at risk with unobtrusive health monitoring—a field Pixie refers to as Connected Care.  Pixie’s patented platform consists of a biosensor, a mobile app, and secure cloud architecture which utilizes machine learning for analysis and disseminates information to remote care teams.

Clinicians can use this information, along with other symptoms, to order additional patient evaluation or more specific diagnostics in a timely manner—which may lower the rate of co-morbidities and hospital admissions due to UTIs and improve antibiotic stewardship.

For incontinent seniors, particularly those with dementia, communicating the early symptoms of UTIs is problematic and symptoms may only be manifest after a senior becomes agitated, disoriented or falls.  Monitoring for UTIs, in addition to making clinical observations, may help caregivers keep incontinent seniors safe and out of the hospital.

According to the Healthcare Cost and Utilization Project by the Agency for Healthcare Research and Quality (AHRQ), more than 850,000 seniors annually receive the primary diagnosis of UTI in the emergency room.  A third of them are hospitalized with UTI as the primary reason for admission.  At an average cost per hospitalization of $25,000, this is a $7B national problem.  Additional hospitalizations due to falls, dehydration, and delirium caused by the infection, as well as cost of rehabilitation care poses a further burden on families and the healthcare system.

“We started Pixie Scientific with a big idea—to unobtrusively monitor health conditions.  To see our first product achieve registration with the FDA and begin shipping to our Early Access customers is truly amazing,” says Scott Meek, Ph.D, head of research and development at Pixie Scientific.  “No other technology platform is focused on meeting the significant unmet need of UTI monitoring in seniors.”

As part of the Aging 2.0 Alliance, Pixie Scientific is committed to innovating to improve the condition of seniors.  Katy Fike, Ph.D, gerontologist and co-founder of Aging 2.0 said, “Screening for UTIs is particularly important for older adults, especially those with latter stage Alzheimer’s Disease or other dementias.  Smart Pads that enable caregivers to continuously monitor seniors have exciting potential to improve the quality of life and quality of care.”

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