SpineX announced today that its first-in-human study backs the use of its proprietary non-surgical treatment for children with cerebral palsy (CP). Los Angeles-based SpineX published the study in Nature Communications. Dr. Susan Hastings and Dr. V Reggie Edgerton led the study. SCiP demonstrated functional improvements with SCiP (spinal cord innovation in pediatrics) in children with […]
Pediatrics
FDA clears Medtronic’s Linq II for kids 2 and up
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for pediatric use of its Linq II insertable cardiac monitor (ICM) system. The Linq II ICM initially received FDA clearance in 2020 for patients aged 21 or older. The clearance announced today allows for use in pediatric patients over 2 years old who have heart […]
The 10 largest medtech employers — and what their employees really think
Employees of the 10 largest medtech employers are happy to be a part of companies having a positive impact on patient populations. That was one major takeaway as MassDevice compiled some current and former employee reviews posted on Glassdoor. Medtronic, Philips and Johnson & Johnson MedTech top the list of largest medtech employers. The 10 […]
OrthoPediatrics raises full year revenue guidance on Street-beating Q2 results
OrthoPediatrics (NSDQ:KIDS) this week posted second-quarter results that beat the overall consensus on Wall Street. The Warsaw, Indiana-based company reported losses of $333,000, or -2¢ per share, on sales of $32.9 million, for the three months ended June 30, for a sales growth of 23.35% compared with Q2 2021. Adjusted to exclude one-time items, earnings […]
Study backs Masimo’s SedLine for guiding anesthesia
Masimo (Nasdaq:MASI) announced today that the findings of a trial support the use of its SedLine brain function monitoring. Results from the randomized, controlled trial were published in the Journal of Clinical Anesthesia. In the trial, Dr. Melody H.Y. Long and colleagues from the KK Women’s and Children’s Hospital in Singapore evaluated the ability of electroencephalogram (EEG)-guided […]
Hyperfine unveils new software for rapid MR brain imaging
FDA recently cleared a software upgrade to Hyperfine’s portable MRI device that enables scenes in under 3 minutes with no ionizing radiation, the Austin, Texas–based company said today. Hyperfine officials think the advancement could significantly improve the monitoring of hydrocephalus — brain fluid build-up — in children. Pediatric patients may have trouble staying still for […]
Abbott Fund grants $750k to education, health equity program
Easterseals announced that it received a $750,000 grant from the Abbott Fund to pilot the Project on Education and Community Health Equity. The grant will fund the project from now through 2025, with the three-year initiative aimed at addressing systemic barriers to high-quality education and healthcare experienced by children and families in underserved communities. According […]
How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff […]
OrthoPediatrics buys Pega Medical for up to $33M
OrthoPediatrics announced today that it has agreed to acquire Pega Medical and its Fassier-Duval Telescopic Intramedullary System for osteogenesis imperfecta and other bone deformities. “Similar to OrthoPediatrics, the Pega organization has been focused exclusively on addressing unmet needs for children whose lives have been impacted by musculoskeletal disorders and diseases. Their product offerings include novel […]
Insulet’s Omnipod 5 “significantly improves” glycemic outcomes in very young children
Insulet (Nasdaq:PODD) announced data supporting the use of its Omnipod 5 automated insulin delivery system in young children. Acton, Massachusetts–based Insulet’s Omnipod 5 significantly improved time in range and reduced HbA1c in children aged 2 through 5.9 years old with type 1 diabetes over 12 months of use, according to the company. Earlier this year, the […]
Abbott to develop biowearable for continuous monitoring of glucose, ketone levels
Abbott (NYSE:ABT) announced today that it is developing a new biowearable for continuously monitoring both glucose and ketone levels. The all-in-one sensor has already garnered FDA breakthrough device designation and will be used in pivotal trials in 2023, with regulatory submissions to follow thereafter. Get the full story at our sister site, Drug Delivery Business News.