Owlet announced today that the FDA granted de novo clearance for its Dream Sock over-the-counter pulse oximetry solution for infants. Lehi, Utah-based Owlet designed the system to enable caregivers to better care for babies at home through advanced digital technologies. According to a news release, the now-cleared Dream Sock monitors and displays live health readings […]
Pediatrics
ZimVie reaches 2,000-child milestone for Tether system
ZimVie announced today that more than 2,000 children have been treated with the Tether vertebral body tethering system. Tether, approved as a humanitarian device by the FDA in 2019, treats skeletally immature patients. These patients require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. They present a major Cobb angle of 30 […]
Mayo Clinic is using Asensus surgical robotics for pediatric cases
Asensus Surgical (NYSE:ASXC) named Mayo Clinic as the previously unidentified hospital customer that has leased the company’s surgical robotics system for pediatric cases. The Mayo Clinic Hospital at the Saint Marys Campus in Rochester, Minnesota, is already using the Asensus Senhance system for pediatric operations, the device developer said in a recent regulatory filing. Research […]
Align Technology launches Invisalign palatal expanders
Align Technology (Nasdaq:ALGN) announced that it today introduced its proprietary, patented Invisalign palatal expander system. The direct 3D-printed device provides rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw). It enables primary, mixed or permanent dentition during the treatment of growing patients. Align said the Invisalign palatal expander is its first […]
Cardinal Health launches next-gen neonatal feeding device
Cardinal Health announced today that it launched its next-generation NTrainer 2.0 device for neonatal feeding. Dublin, Ohio-based Cardinal Health designed the NTrainer 2.0 to help premature and newborn infants develop oral coordination skills. These skills — important for a speedy transition to independent feeding — helps to reduce NICU length of stay. Through real-time assessment […]
PolyVascular, CobiCure partner on non-surgical pediatric heart valve
CobiCure Medical Technologies announced that it provided $2 million in funding to PolyVascular to advance a pediatric heart valve. Houston-based PolyVascular — a MedTech Innovator accelerator participant in 2020 — develops a first-of-its-kind heart valve. The potentially transformative, non-surgical valve could treat young children suffering from congenital heart disease. New York-based CobiCure, a non-profit pediatric […]
Masimo initiates full U.S. launch of Stork smart home baby monitor
Masimo announced today that it initiated the full U.S. market release for its Stork home baby monitoring system. Stork offers a continuous and accurate view of a baby’s health data. It leverages Masimo’s noninvasive neonate monitoring technologies. The Irvine, California-based company kicked off its initial launch for the system in May of this year. “We […]
Leading U.S. hospital begins pediatric program with Asensus surgical robot platform
Asensus Surgical (NYSE:ASXC) announced today that an unnamed leading U.S. hospital initiated a pediatric program with its Senhance platform. Research Triangle Park, North Carolina-based Asensus picked up a pediatric indication for Senhance from the FDA in March. Senhance, Asensus’ flagship offering for its Performance-Guided Surgery, is a first-of-its-kind digital laparoscopic surgical robot. It uses augmented intelligence […]
Luminopia raises $16M for digital lazy eye therapeutic
Luminopia announced that it raised $16 million to support its software-based therapeutic for amblyopia, commonly known as lazy eye. Cambridge, Massachusetts-based Luminopia saw its oversubscribed Series A financing round led by U.S. Venture Partners (USVP). New investor Broadfin Advisors supported alongside existing investors ShangBay Capital and Vertical Group. In conjunction with the financing. USVP General […]
New data supports Medtronic MiniMed 780G automated insulin delivery system for children
Medtronic today announced positive clinical and real-world data supporting its MiniMed 780G automated insulin delivery system. The latest data sets evaluated the recently FDA-approved system across a wide range of users. They looked at younger patients, those not meeting glycemic goals and individuals using simplified meal announcement technology. Medtronic presented these results at the 83rd […]
FDA approves Globus Medical’s non-fusion scoliosis correction system
Globus Medical this week announced it received FDA approval for its Reflect non-fusion scoliosis correction system for young patients. The Audubon, Pennsylvania-based company designed Reflect to correct progressive scoliosis in young patients while preserving motion, maintaining stability and allowing for future modulated growth. “Treating scoliosis in the growing spine presents challenges related to reduced spinal […]
