Senseonics (NYSE:SENS) announced that the first pediatric study participant received an Eversense 365-day CGM insertion. The insertion took place as part of the company’s ENHANCE clinical trial at the AMCR Institute. AMCR, a clinical research center, focuses on pre-diabetes, type 1, type 2 diabetes and obesity. The study operates under the direction of Dr. Timothy […]
Pediatrics
Study backs Tandem Control-IQ artificial pancreas in young children
Tandem Diabetes Care (Nasdaq:TNDM) announced positive study data for its artificial pancreas using Control-IQ technology. The study demonstrated improved blood sugar control in children ages 2-6 with type 1 diabetes. It evaluated an artificial pancreas using the Tandem t:slim x2 insulin pump with Control-IQ technology. Results were published in the New England Journal of Medicine. […]
Akili lays off 46 workers
Akili announced that its board of directors approved an operating plan for 2023 that includes a 30% workforce reduction. The Boston-based digital therapeutic developer’s reduction reaches across different areas and functions. In total, 30% of Akili’s workforce amounts to 46 employees. The company communicated the decision to employees on Jan. 12 and expects to complete […]
Vero Biotech raises $30M for tankless nitric oxide delivery system
Vero Biotech announced today that it raised $30 million to support its Genosyl inhaled nitric oxide (iNO) delivery system. The financing comes just days after the company received FDA approval for Genosyl. The third-generation Genosyl delivery system features faster dosing, simpler workflow and operational efficiency. Petrichor, a healthcare-dedicated growth capital provider, led the financing. Atlanta-based […]
FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech
Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide (iNO) delivery system. Atlanta-based Vero Biotech developed its third-generation Genosyl delivery system for respiratory therapists. Its new features include faster dosing, simpler workflow and operational efficiency. The system speeds up dosing with an adaptive sensor and automated cassette activation feature. […]
FDA clears Insulet Omnipod 5 for children two years and older
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes. Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older. In June, […]
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, […]
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. Abbott Park, Illinois-based Abbott said in a news release that the […]
BioMarin wins FDA approval for injection to increase growth in children with dwarfism
BioMarin Pharmaceutical (NSDQ:BMRN) announced today that the FDA granted accelerated approval for its Voxzogo injection. San Rafael, California-based BioMarin’s Voxzogo (vosoritide) injection has an indication to increase linear growth in pediatric patients with achondroplasia (a form of dwarfism) five years of age and older with open epiphysis (growth plates). Continued approval may be contingent upon […]
Dermavant doses first patient in trial of topical cream for atopic dermatitis
Dermavant Sciences announced today that it dosed the first patient in a Phase 3 pivotal study of its atopic dermatitis (AD) treatment. Long Beach, California-based Dermavant’s double-blind, vehicle-controlled pivotal study evaluates tapinarof for the treatment of AD, according to a news release. The company developed tapinarof as an investigational novel, therapeutic aryl hydrocarbon receptor modulating […]
