Plakous Therapeutics announced that it received more than $1.7 million in a research grant from he Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health (NIH). The Phase I-II fast-track small business innovation research (SBIR) grant, worth up to $1.725 million, is slated to help Plakous develop novel […]
Berlin Heart touts pediatric heart device post-approval performance
Berlin Heart announced today that it completed the post-approval surveillance process for its Excor pediatric ventricular assist device (VAD). Post-approval surveillance is a requirement of the post-market approval that Berlin Heart’s Excor received from the FDA in June 2017. The company’s final report to the FDA confirmed positive results in pediatric heart failure patients treated […]
20 medical device startups you need to know
The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention. Tom Salemi, DeviceTalks Editorial Director and Sean Whooley, Assistant Editor A number of medical device startups continue to make waves across the space, with new technologies and eye-watering fundraising rounds highlighting some exciting prospects. […]
FDA clears Preceptis Medical’s in-office ear tube placement for kids
Preceptis Medical today announced FDA clearance that allows placement of its Hummingbird tympanostomy tube system in an ENT surgeon’s office. Officials at Maple Grove, Minn.–based Preceptis say the Hummingbird system significantly reduces trauma and procedure time for ear tube placement in young children. Kids receiving the ear tubes don’t need general anesthesia, and they don’t […]
Akili wins CE mark for digital ADHD treatment
Akili Interactive announced today that it received CE Mark approval for its EndeavorRx video game for children with attention deficit hyperactivity disorder (ADHD). Boston-based Akili’s prescription treatment is delivered through a video game experience as a way to improve attention function as measured by computer-based testing in children between ages 8 and 12 with primarily inattentive […]
OrthoPediatrics commences public offering
OrthoPediatrics (NSDQ:KIDS) announced earlier this week that it commenced an underwritten public offering of its common stock. The Warsaw, Ind.-based pediatric orthopedics company intends to grant underwriters a 30-day option to purchase additional shares of common stock at the public offering price. According to a news release, there is no assurance as to whether or […]
NuVasive launches pediatric spinal deformity device
NuVasive (NSDQ:NUVA) announced today that it launched its Reline 3D posterior fixation system for pediatric spinal deformities. San Diego-based NuVasive’s latest addition to its spine portfolio is now commercially available around the globe for treating adolescent idiopathic scoliosis (AIS). The Reline 3D is designed to turn a multi-step technique into a holistic, single-plane correction to offer […]
Tandem Diabetes Care wins expanded FDA indication for insulin pump
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 Control-IQ as […]
FDA clears video game Rx for kids with ADHD
Akili Interactive announced that it received FDA clearance for its EndeavorRx video game for children with attention deficit hyperactivity disorder (ADHD). Boston-based Akili’s prescription treatment is delivered through a video game experience to improve attention function as measured by computer-based testing in children between ages 8 and 12 with primarily inattentive or combined-type ADHD. EndeavorRx […]
Abbott, Medtronic go head-to-head at ADA conference
Major medtech companies vied for the biggest news splash at this year’s annual meeting of the American Diabetes Association, announcing promising results from studies of patients who used their latest diabetes technology. The virtual 80th Annual American Diabetes Association Virtual Scientific Sessions, which runs through Tuesday, so far has featured news out of Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and several smaller […]
NCC-PDI announces pitch competition for COVID-19-related pediatric devices
The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced a pitch competition for COVID-19-related pediatric medical devices. The competition, which is accepting submissions from now through July 6, focuses on devices that support home health monitoring and telehealth to improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic, according to a news […]
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