While FY2017’s approvals notably served all four pediatric age groups, the majority of pediatric devices approved over the last decade are not indicated for children under the age of 12. What’s more, a large portion of the devices indicated for FDA’s ‘adolescents’ category are only authorized for use in patients 18 or older.
Category: Media Mention
The Houston, TX-based company is developing the Aortix system, a percutaneous blood pump initially targeted for treating patients with heart failure and worsening kidney function. The investment will fund the company’s pilot study through the activities needed to support the submission of an FDA IDE application for its pivotal trial. To date, the firm said […]
Developing medical devices in general is costly, but there is funding available for companies that are willing to create products specifically for pediatrics.
Seattle-based Bardy Diagnostics, Inc., a provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (CAM), a P-wave centric ambulatory cardiac monitor and arrhythmia detection device, announces that it was selected as one of six winners of the “Make Your Medical Device Pitch for Kids!” Competition hosted by the Sheikh […]
There has to be a better way. That was the theme for the healthcare technology innovators, clinicians, regulators, and investors who convened in Philadelphia earlier this fall to discuss, encourage, and-perhaps most important-provide a total $150,000 in grants for six companies developing innovative healthcare technology that focuses on the needs of children.
Design Mentor aims to improve patients’ circulation during cardiopulmonary bypass surgery
Two companies affiliated with Texas Medical Center member institutions recently experienced advancements for their medical device products.
Competition awards expanded because of high caliber of medical devices presented for pediatric cardiovascular patients.
A total of $150K was awarded to six pediatric cardiovascular innovations during the medical device pitch competition at the 6th Annual Pediatric Device Innovation Symposium hosted by Children’s National Health System.
Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (“CAM”), the world’s first P-wave centric ambulatory cardiac monitor and arrhythmia detection device, announced it was selected as one of six winners of the “Make Your Medical Device Pitch for Kids!” Competition hosted by […]