Spark Biomedical announced today that the FDA granted breakthrough device designation to its transcutaneous electrical nerve stimulator designed to reduce signs and symptoms of neonatal opioid withdrawal syndrome (NOWS). NOWS results from exposure to prescription or non-prescription opioids such as methadone or heroin during pregnancy. Currently, no nationwide standard of care exists for managing NOWS, although […]
Pediatrics
Medtronic launches pediatric blood-filtering device in U.S.
Medtronic (NYSE:MDT) announced today that it launched its Carpediem cardio-renal pediatric dialysis emergency machine in the U.S. Fridley, Minn.-based Medtronic’s Carpediem machine received FDA de novo clearance in May for providing continuous dialysis in critically ill young children. The first-of-its-kind machine is indicated for use in acute kidney injury or fluid-overloaded patients requiring hemodialyiss or hemofiltration […]
FDA clears WishBone Medical pediatric external fixation device
WishBone Medical this week announced that it received FDA 510(k) clearance for its pediatric Smart Correction external fixation system. The device features hexapod external fixator hardware and planning software for a higher accuracy and design that enable surgeons to perform strut replacement procedures. It is designed to stabilize and maintain alignment of complicated fractures, soft […]
The top 10 medical disruptors of 2021
For the past 18 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Will Morris, executive medical director of Cleveland Clinic Innovations, and Dr. Akhil Saklecha, managing […]
PhotoniCare raises more than $6M
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 […]