Pediatric Device Stakeholders

News & Events

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.
 

Penn Health-Tech Accepting Applications for the Joint Call for Proposals for Medical Devices and Health Technology Development

Full information available here.

---

GENERAL

Penn Health-Tech and the Penn Medicine Center for Health Care Innovation invite faculty from the University of Pennsylvania, Penn Medicine, and Children’s Hospital of Philadelphia (CHOP) to submit proposals for pilot funding by September 23, 2019 at 5pm. The goal of this funding is to support the development of medical device and health technology projects that address important unmet medical needs. Proposals that cross departments and schools and promote sharing expertise are strongly encouraged.

Selected proposals will receive

  • Pilot funding: From $5,000 up to $50,000
  • Mentorship and project support: Advisors will help you refine your design, build partnerships and work towards achieving proof of concept
  • Access to experts

 

TIMELINE

July 12 – September 23: Application period

October 28: Interview day (a select group of finalists will be invited in for an interview)

November: Notification of application status


 

HOW TO APPLY
  1. Create a SurveyMonkey account using your University of Pennsylvania, Penn Medicine, or Children’s Hospital of Philadelphia email address.
  2. Verify your email address.
  3. Fill out the application in its entirety. To preview a sample application, click here.
  4. Submit your application by 5 PM on Monday, September 23.

 

ELIGIBILITY

See full Terms, Conditions and Limitations>>

PHT ELIGIBILITY

Faculty at the University of Pennsylvania and Penn Medicine are eligible to receive funding for proof of concept projects and promising inventions. CHOP employees are also eligible to receive funding for proof of concept projects and promising inventions. Team leader or Principal Investigator must be a full-time faculty member of Penn or full-time research faculty member of CHOP.

MDA ELIGIBILITY

Penn Medicine and University of Pennsylvania employees are eligible to participate in the Medical Device Accelerator Program.


 

FUNDING SIZE

Pilot funding range from $5,000 up to $50,000 for one year with the potential for additional funding based on project progression. Please note that awards are non-transferable will be given only to the full-time Penn or CHOP research faculty members (through Penn or CHOP, as applicable) to be spent on research in or directed by Penn or CHOP facilities.


 

 

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.


Links

Provides an overview of the FDA's PDC program, of which we are part

 

Provides guidance regarding device classification, basic regulatory requirements for approval, Quality System regulation, labeling requirements, and medical device reporting

 

 

Allows you to search the database of issued U.S. patents

 

       An institute based at the University of Pittsburgh with a primary focus of the development of technology to address tissue and organ insufficiency.

 

       A medical device development firm with a commercialization process focused on building value, risk reduction, design for manufacture, and shortening time to market.

 

A partner organization of the PPDC. NAMSA is a medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. 

 

Provides information about the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, including opportunities to apply for federal funding to support small companies in research and development that has a strong potential for commercialization

 

  • To access the other Pediatric Device Consortia:

National Capital Consortium for Pediatric Device Innovation

Southwest National Pediatric Device Consortium

UCSF-Stanford Pediatric Device Consortium

Consortium for Technology and Innovation in Pediatrics