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Pediatrics

FDA approves Medtronic MiniMed 770G insulin pump for young children

August 31, 2020 By Nancy Crotti

(Image courtesy of Medtronic) The FDA has approved the Medtronic (NYSE:MDT) MiniMed 770G  hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years. The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose monitor values for for such young children, according to the agency. The FDA […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pediatrics, Wall Street Beat

Tandem Diabetes Care wins expanded FDA indication for insulin pump

June 17, 2020 By Sean Whooley

Tandem Diabetes Care - updated logo

Tandem Diabetes Care (NSDQ:TNDM) announced today that it won an expanded pediatric indication from the FDA for its t:slim X2 insulin pump. The t:slim X2 with Control-IQ technology won FDA clearance for controlling Type 1 diabetes in December, which was followed by a commercial launch in the U.S. the next month. Tandem touts t:slim X2 with […]

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Pediatrics, Regulatory/Compliance Tagged With: FDA, Tandem Diabetes Care

Smith & Nephew acquires Tusker Medical

January 24, 2020 By Danielle Kirsh

smith-nephew-logo

Smith & Nephew (NYSE:SNN) today said it acquired Tusker Medical for an undisclosed amount. Tusker Medical develops the Tula System, which is an in-office ear tube delivery system to treat recurrent or persistent ear infections. The pediatric ear tubes won FDA breakthrough device designation in November last year. “The Tula System is a truly innovative option for physicians […]

Filed Under: Drug-Device Combinations, Featured, Pediatrics Tagged With: Smith & Nephew, Tusker Medical

Tusker Medical’s pediatric ear tubes land breakthrough device designation

November 26, 2019 By Nancy Crotti

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pediatrics, Research & Development Tagged With: FDA, Tusker Medical

Teva launches generic EpiPen Jr.

August 20, 2019 By Sean Whooley

Teva Pharmaceutical logo - updated

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 […]

Filed Under: Auto-injectors, Featured, Pediatrics, Pharmaceuticals Tagged With: Mylan, Teva Pharmaceuticals

BD recalls SmartSite syringe administration set

July 2, 2019 By Brad Perriello

Becton Dickinson

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, […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Hospital Care, Pediatrics, Recalls, Regulatory/Compliance Tagged With: Becton Dickinson

ETV/CPC show positive outcomes in babies with hydrocephalus

July 24, 2018 By Danielle Kirsh

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 […]

Filed Under: Pediatrics Tagged With: blog, Vector Blog

Following FDA nod, Ferring plans launch for needle-free drug-delivery system

July 23, 2018 By Sarah Faulkner

Ferring Pharmaceuticals

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pediatrics, Pharmaceuticals, Regulatory/Compliance Tagged With: ferringpharmaceuticals

Medtronic’s MiniMed system wins FDA nod for pediatric indication

June 22, 2018 By Sarah Faulkner

Medtronic

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pediatrics, Regulatory/Compliance, Wall Street Beat Tagged With: Medtronic

Study: Digital tools prove useful for kids with Type I diabetes

March 19, 2018 By Sarah Faulkner

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 […]

Filed Under: Big Data, Diabetes, Featured, Patient Monitoring, Pediatrics Tagged With: unitedhealth

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