The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of […]
Teva launches generic EpiPen Jr.
Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available in the U.S. The device wholesales to most retail pharmacies in packs of two for $300, or $150 per pen. Teva’s product is less than half the cost of Mylan’s non-generic EpiPen Jr., which lists at $643.89 per two-pack at Drugs.com. ”We’re […]
BD recalls SmartSite syringe administration set
Becton Dickinson (NYSE:BDX) recalled nearly 3,000 leaky SmartSite syringe administration sets used in the neonatal intensive care unit in what the FDA deemed a Class I action. Franklin Lakes, N.J.-based BD issued an urgent medical device recall in February involving 2,900 of its SmartSite syringe administration sets, which are used with infusion pumps to deliver medication, […]
ETV/CPC show positive outcomes in babies with hydrocephalus
Hydrocephalus, literally “water on the brain,” is an abnormal build-up of cerebrospinal fluid in the brain cavities known as ventricles. In infants, it can be congenital (it often accompanies spina bifida, for example), or it can be caused by brain hemorrhage or infection. The usual treatment is surgery to implant a shunt, which drains the […]
Following FDA nod, Ferring plans launch for needle-free drug-delivery system
Ferring Pharmaceuticals said last week that the FDA approved its injectable somatropin product for four additional pediatric indications: idiopathic short stature, short stature associated with Turner syndrome, short stature born small for gestational age with no catch-up growth by 2 – 4 years and growth failure in short stature homeobox-containing gene deficiency. In connection with […]
Medtronic’s MiniMed system wins FDA nod for pediatric indication
The FDA this week expanded its approval for Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop diabetes management device to include people ages 7 to 13 with Type I diabetes. The system, which automatically monitors blood sugar levels and doses basal insulin accordingly, was initially approved in the U.S. for people ages 14 and older. Medtronic’s MiniMed […]
Study: Digital tools prove useful for kids with Type I diabetes
A six-month study found that children and teenagers with Type I diabetes who participated in an intensive remote therapy pilot program saw improved blood glucose control compared to those who received traditional care. The study, conducted by UnitedHealth (NYSE:UNH) and Children’s Hospitals & Clinics of Minnesota, was published last month in the journal Pediatric Diabetes. Kids who […]
Medtronic looks to expand MiniMed 670G into pediatric diabetes
Medtronic (NYSE:MDT) touted data today from an at-home pediatric study of its MiniMed 670G hybrid closed-loop diabetes management system. The company’s study included 105 kids, ages 7 to 13, and found that patients spent more time in the target blood glucose range, had less glycemic variability and experienced less hypo- and hyperglycemia compared to baseline data. […]
FDA approves Bracco’s contrast agent for pediatric CNS imaging
The FDA has approved a label change to Bracco Diagnostics‘ MultiHance MRI contrast agent. The company’s product can now be used to visualize lesions with abnormal vascularity of the brain and spine in patients younger than two years old. Data collected in pediatric patients under the age of two showed that a dose of 0.05 […]
FDA revises label on opioid cold meds to limit pediatric use
The FDA this week announced that it’s mandating labeling changes to cut the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in kids under 18 years of age. The agency wrote in a statement that the risks of these drugs outweigh their potential benefits for children. The medications will also receive […]
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