The FDA has approved Kaleo‘s Auvi-Q epinephrine auto-injector designed to treat life-threatening allergic reactions in infants and small children, according to the privately-held biopharma company. The device, which Kaleo touts as the first of its kind, was given priority review by the FDA. The 0.1 mg Auvi-Q auto-injector has a shorter needle and a lower […]
Pediatrics
How slugs, snails & worms inspired Gecko Biomedical’s biocompatible sealant
The story behind Gecko Biomedical’s biocompatible sealant starts in the summer of 2009, when Boston Children’s Hospital‘s chief of cardiac surgery reached out to Jeffrey Karp about a problem he was experiencing in the operating room. Dr. Pedro del Nido told Karp, a professor of medicine at Harvard and the director of the Laboratory for […]
Medtech stories we missed this week: September 8, 2017
From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating […]
Mallinckrodt enrolls first infant in registry for inhaled nitric oxide gas
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that it included the first patient in its Phase IV registry evaluating the use of inhaled Inomax nitric oxide gas for premature neonates compared to term and near-term newborns. Inomax, which has FDA approval, is designed to boost oxygenation and lessen the need for extracorporeal membrane oxygenation in term and near-term […]
Catalent, Rutgers partner to study pediatric drug formulation and delivery
The Catalent Applied Drug Delivery Institute said today that it inked a deal to work with the dept. of pharmacy practice at Rutgers University in an effort to identify and address the challenges linked to pediatric drug formulation and delivery. The collaboration plans to focus on the development and administration of medicines to children by […]
Windtree Therapeutics reports Phase II data for inhaled surfactant
Windtree Therapeutics (NSDQ:WINT) reported data today from the 221-patient Phase IIb trial of its aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants. The Aerosurf trial evaluated aerosolized KL4 surfactant administered to premature infants 28 to 32 weeks gestational age in 2 dose groups with up to 2 repeat doses, compared […]
Bristol-Myers Squibb launches prefilled syringe option for arthritis drug
Bristol-Myers Squibb (NYSE:BMY) launched a subcutaneous administration option for Orencia, a biologic indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients who are at least 2 years old. The prefilled syringe enables physicians, caregivers and patients to administer Orencia at home. Orencia is traditionally administered via IV infusion. “The data supporting this […]
Halo Pharma launches development & manufacturing facility for pediatric drugs
Halo Pharma launched its Pediatic Center of Excellence today to support the development and manufacturing of drugs tailored for pediatric indications. The company said it will use the manufacturing facility to continue working with pharmaceutical companies to develop pediatric dosage forms of already-approved adult drugs. When the FDA requests that a company conduct clinical trials for […]
Artificial pancreas shows promise in pediatric study
A pilot study evaluating an artificial pancreas in children with Type I diabetes found that the device helped kids control their condition, according to researchers at the University of Virginia. The artificial pancreas was developed at the UVA Center for Diabetes Technology and features a smartphone powered by algorithms that wirelessly link to a glucose monitor […]
Bracco Diagnostics wins another FDA nod for Lumason microspheres
Bracco Imaging U.S. subsidiary Bracco Diagnostics said today that it won FDA approval for its Lumason microsphere contrast agent to be used in ultrasonography of the urinary tract in pediatric patients with suspected or known vesicoureteral reflux. “The approval of Lumason for voiding ultrasonography answers an unmet medical need for an effective imaging study to […]
