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BioWorld - Tuesday, June 16, 2026
Home » Topics » Disease categories and therapies » Neonatal/pediatrics

Neonatal/pediatrics
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Close-up of eye

All eyes are on autism screening app for toddlers

May 25, 2021
By Annette Boyle
With the support of the NIH’s National Institute of Child Health and Human Development and the National Institute of Mental Health, researchers at Duke University’s Center for Autism and Brain Development have developed a mobile app that can quickly screen toddlers for autism spectrum disorder without the need for specialized skills.
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Mohamed Khalifa wearing Oxyflex device, holding smartphone showing reading

Tecmoled completes initial testing phase for its ultraflexible organic oximeter for neonate care

May 19, 2021
By Bernard Banga
PARIS – Tecmoled SAS has just completed the initial testing phase for its wireless oximeter. A prototype has been tested over the past four months on 30 healthy subjects, aged 2 to 70 years, to measure oxygen saturation (SpO₂), heart rate and body temperature.
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Sonarmed image

Medtronic breathes new life into infant airway obstruction monitoring system with U.S. launch

May 10, 2021
By Annette Boyle
Almost 11 years to the day after first gaining FDA clearance, the Sonarmed airway monitoring system finally launched on a commercial scale in the U.S. The new rollout appears likely to revive the product’s prospects as it comes with significantly increased financial backing and deep connections to hospitals as a result of Sonarmed’s acquisition by Medtronic plc in December 2020. The system, which uses acoustic technology to identify endotracheal tube obstruction and verify proper tube positioning in neonates and infants who require invasive mechanical ventilation, has been implemented in a small number of hospitals to date.
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Neoguard product image

Neopenda receives CE mark, raises $1.4M

April 16, 2021
By Annette Boyle
Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients.
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Product image

Medtronic rolls out first acute dialysis machine for babies in the U.S.

Dec. 8, 2020
By Meg Bryant
Critically ill infants in need of continuous renal replacement therapy (CRRT) are often treated using machines intended for adults, leading to a number of challenges and a high risk of complications and death. Now, Medtronic plc has launched a pediatric and neonatal acute dialysis machine in the U.S. that is specifically designed for patients weighing between 2.5 and 10 kilograms. The Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine, the first of its kind in the U.S., received U.S. FDA clearance in April via the de novo pathway and is classified as a class II device.
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Newborn feet

FDA gives nod to first newborn screening test for Duchenne muscular dystrophy

Dec. 13, 2019
By Meg Bryant
Perkinelmer Inc., of Waltham, Mass., has won a thumbs up from the U.S. FDA for its GSP Neonatal Creatine Kinase-MM kit. The assay is the first test approved in the U.S. for help in screening newborns for Duchenne muscular dystrophy (DMD), a rare but devastating genetic disorder. While there is no known cure for DMD, earlier screening and diagnosis could lead to improvements in quality of life by enabling earlier and more personalized treatment of symptoms. The kit’s approval opens the door for states to include DMD among the battery of tests newborns typically undergo, such as phenylketonuria, cystic fibrosis and congenital heart disease.
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Mayo Clinic teleneonatology program improves outcomes, reduces transfers from smaller hospitals

Oct. 7, 2019
By Meg Bryant
Roughly 10% of newborns require some form of assistance at birth, and 1% need major resuscitative efforts. The time to help one of these babies can be measured in minutes, so having the right specialist on hand can have a huge impact on the child's outcome. Six-and-a-half years ago, the Mayo Clinic launched the Newborn Resuscitation Telemedicine Program (NRTP) to offer telemedicine consults to community hospitals within its health system during high-risk neonatal resuscitations. The program has been successful in reducing unnecessary transfers and growing the number of patient referrals to Mayo Clinic.
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FDA grants humanitarian device exemption for Apifix scoliosis treatment

Sep. 5, 2019
By Annette Boyle
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