Category: Media Mention

Page: Pediatric device approval numbers are slowly rising, but not necessarily for young kids

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.

Page: Procyrion Brings in $30M to Support Pilot Trial

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 […]

Page: Bardy Diagnostics Selected as a Winner of Pediatric Medical Device Contest

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 […]

Page: Competition Seeks to Bridge Gap for Pediatric Medical

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.

Page: Bardy DIagnostics Selected as a winner of the Children’s

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 […]