Young Entrepreneurs Receive FDA Clearance for Medical Device Poised to Disrupt Newborn Care Market

VERITAS Vision System Is Introduced by Johnson & Johnson

The company will offer live demos of the new system in a wet lab at the Johnson & Johnson booth (#2813) this weekend at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting.

GenesisCare Orders 27 Elekta Flexitron Treatment Devices

"GenesisCare continues to demonstrate its commitment to improving patient outcomes worldwide and Elekta is delighted to play a vital partnering role to achieve this mission," said Gustaf Salford, Elekta's President and CEO.

FoodMarble AIRE Shown to Exceed the Performance of ‘Gold Standard’ SIBO Testing in Clinical Trial

SIBO is a very common disorder where there are excessive bacteria present in the small intestine. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.

NeoLight, located in Phoenix, Arizona, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Skylife™ portable phototherapy system. The Skylife device delivers a narrow band of high-intensity blue light via blue light emitting diodes to provide treatment for neonatal unconjugated hyperbilirubinemia (jaundice).

NeoLight Co-Founder and CEO Vivek Kopparthi comments: “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.”  Kopparthi concluded, “Our approach always starts with one question – what is best for the baby? This question drives everything we do.”

Infant jaundice occurs when a baby’s blood contains an excess of bilirubin, a byproduct of red blood cells. Neonatal jaundice is a common condition, particularly in babies born before 38 weeks gestation (preterm babies). Jaundice in the newborn must be carefully monitored, as although complications are rare, a high bilirubin level associated with severe infant jaundice or inadequately treated jaundice may cause brain damage. Jaundice occurs in approximately 60% of the 4 million neonates born yearly in the United States

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