Middle ear imaging technology developer PhotoniCare today filed an SEC Form D to confirm the sale of nearly $6.3 million in equity. Champaign, Ill.-based PhotoniCare, which made the first sale in the new notice offering on Aug. 25, 2020, does not intend for it to last longer than one year. It is not being made […]
FDA approves Medtronic MiniMed 770G insulin pump for young children
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 such young children, according to the agency. The FDA approved an earlier MiniMed […]
Natus Medical slides on missed earnings projections
Natus Medical (NSDQ:NTUS) shares took a hit today on second-quarter results that came up short of the consensus earnings forecast. The Pleasanton, Calif.-based maker of monitoring and diagnostics for newborns posted losses of -$8.9 million, or -26¢ per share, on sales of $84.8 million for the three months ended June 30, 2020, for a bottom-line slide […]
Vizient to distribute WishBone Medical’s pediatric ortho implants
WishBone Medical announced today that it entered into a national agreement with Vizient to provide orthopedic implants to pediatric patients. Warsaw, Ind.-based WishBone said in a news release that Vizient’s membership base includes more than 50% of the nation’s acute care providers, allowing WishBone’s “Just-In-Time” supply of single-use sterile kits for children with orthopedic issues […]
Medipines wins medtech for kids contest
MediPines announced that it was selected as a winner in a COVID-19 edition of a National Capital Consortium for Pediatric Device Innovation competition. The “Make Your Medical Device Pitch for Kids!” competition, presented by the FDA-sponsored consortium, centered on COVID-19 related innovations in pediatric medical devices. Sixteen finalists competed in a virtual pitch event with […]
Plakous lands $1.7m from NIH to develop newborn treatment
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 […]
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