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Little Sparrows Technologies Receives FDA Clearance for an Innovative, Portable Medical Device for Treating Infant Jaundice

Start-up receives FDA 510(k) clearance for bili-hut™ Neonatal Phototherapy System, a cost-effective phototherapy device for treating infant jaundice at home or in a hospital.

From www.little-sparrows-tech.com:

Somerville, MA, September 17, 2019 – Little Sparrows Technologies, a neonatal medical device startup committed to promoting the well-being of newborns, announced today it has received 510(k) clearance from the Food and Drug Administration (FDA) for the bili-hut™. The bili-hut is an innovative ultraportable neonatal phototherapy system that leverages a bassinet-like design to treat hyperbilirubinemia, commonly known as neonatal jaundice. The device features a unique curved light emitting diode (LED) illumination canopy that delivers high-intensity blue light phototherapy. This highly portable device allows newborns to effectively undergo jaundice treatment anywhere – at home or in a hospital setting.

“Neonatal jaundice is very common and is often diagnosed when a newborn is almost ready for discharge from the hospital or after the baby is home for a few days, requiring longer hospital stays or readmittance,” said Dr. Donna Brezinski, CEO and founder, Little Sparrow Technologies. “Phototherapy treatment typically occurs in NICUs, which separates newborns from their mothers who are bonding and establishing breast feeding. The bili-hut provides the best possible start for jaundiced babies by enabling treatment at the mother’s side, whether in the hospital or at home.”

Neonatal jaundice is a transitional phenomenon which affects three out of five newborns in their first weeks of life. Jaundice causes a yellow discoloration of the skin and eyes in newborns and typically subsides within a few days. In newborns with severe jaundice, blue light phototherapy is required to prevent irreversible neurologic injury.

Jaundice is also one of the most common diagnoses associated with infant readmission to a hospital in the first month of life. In the United States, it is estimated that 100,000 infants develop severe jaundice, costing the healthcare systems $500M annually for hospital-based care. Hospital phototherapy devices can be daunting for new parents and extended hospital stays are often stressful and expensive.
Invented by Dr. Brezinski, a neonatal-perinatal specialist, the bili-hut is capable of delivering hospital intensity phototherapy at the parent’s bedside in either the postpartum room or at home, presenting a new, innovative and cost-effective approach to addressing the challenges of treating jaundice. With the bili-hut doctors can improve the quality of care for infants by maintaining a close relationship with parents while helping to reduce emergency room visits and readmissions.

The bili-hut will be on display at the Little Sparrows Technologies booth #133 at the 2019 American Academy of Pediatrics National Conference & Exhibition in New Orleans, October 26-28.
For more information on the bili-hut, visit www.little-sparrows-tech.com.

About Little Sparrows Technologies:

Founded in 2013 by Harvard Medical School affiliated doctors, Little Sparrows Technologies offers an innovative approach for treating jaundice. The bili-hut™ is a cost-effective phototherapy device that uses blue LED lights in a reflective bassinet that is capable of operation on battery power. It is simple to use and collapsible for easy transport. Little Sparrows has received two phases of funding from the NIH’s Small Business Innovation Research (SBIR) program, and The World Health Organization included the bili-hut in its Compendium of Medical Devices for Global Health. Little Sparrows Technologies was the winner of a 2018 Patents for Humanity Award. The company offers solutions to support hospitals, US pediatrician offices and international implementations. For more information, visit www.little-sparrows-tech.com.
 

FDA to Modernize 510(k) Program

FDA Commissioner, Scott Gottlieb, recently announced plans to update the FDA's 510(k) pathway for approving new medical devices.  The new plan emphasizes a need to be less reliant on older predicate technologies, and may publish when an applicant uses a predicate more than 10 years old.

"We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria."

Read the full press release here.


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