Email
Password
Remember meForgot password?
    Log in with Twitter

article imageStartup gets FDA clearance for device to treat newborn jaundice

By Karen Graham     Nov 1, 2017 in Health
Phoenix - NeoLight, an Arizona State University spinout that engineers, designs and manufactures technologies to treat infants with life-threatening medical conditions, announced it had received FDA clearance to market Skylife, a portable phototherapy system.
NeoLight, located in Phoenix, Arizona, stresses their work is grounded in empathy for infants and their families, sound engineering principles, and the belief that the best medical technology is the kind that helps people lead normal healthy lives.
On October, 30, NeoLight announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its trademark Skylife portable phototherapy system. The device delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia (jaundice).
The Skylife device delivers a narrow band of high-intensity blue light via blue light emitting diode...
The Skylife device delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia
Neolight
Vivek Kopparthi, the co-founder, and CEO of the young company said, “We are thrilled to have 510(k) clearance for the Skylife phototherapy system and see this as a key milestone in our mission to reinvent the newborn care space through empathy-driven innovation. Our approach always starts with one question – what is best for the baby? This question drives everything we do.”
A company that has learned to love their products
Kopparthi has a background in electronic engineering, and has overseen organizations of 100-plus employees, served as a startup advisor, and consulted for global corporations. In June this year, writing about entrepreneurs with new business ideas, Kopparthi talked about his company's "love" for their product.
He cited Steve Jobs, saying Jobs believed that “people with passion can change the world for the better.," adding "If you don’t love your product, you’ll have nothing tangible from which to draw your confidence in order to execute on your vision." And this love for your product is what has driven NeoLight. His advice for entrepreneurs is simple, "fall in love with your product, not the idea of potential success."
A newborn in an incubator at a neonatal intensive care unit.
A newborn in an incubator at a neonatal intensive care unit.
Zerbey
What is infant jaundice?
Infant jaundice occurs when a baby, typically a newborn, has an excess of bilirubin in its blood. This causes the child's skin to take on a "yellow" color, and often, the white's of the child's eyes will be yellow. Neonatal jaundice is a common condition, often seen in babies born before 38 weeks gestation (preterm babies).
In rare cases, severe infant jaundice or inadequately treated jaundice may cause brain damage. Jaundice occurs in approximately 60 percent of the four million neonates born yearly in the United States, according to the press release.
More about neolight, FDA clearance, startup company, empathydriven innovation, phototherapy
 
Latest News
Top News