Hannah joined Medtech Insight from HBW Insight in August 2022 and reports on cybersecurity, patent law and other facets of medical device regulation. Hannah is passionate about the intersection of science and communication and holds a bachelor’s degree in biology from Carnegie Mellon University.
Latest from Hannah Daniel
The FDA designated class II special controls classifications for two diagnostics and force separation catheters.
Despite a March recall and a following update, Tandem’s t:slim X2 application is still causing the battery-depleting defect.
Avenda’s chief operating officer Brit Berry-Pusey spoke to Medtech Insight about the company’s CPT III code for its prostate cancer mapping AI and how regulatory bodies can align to support innovators.
This week, Medtronic recalled a nerve monitoring system due to reports of false responses. The US FDA approved the first auto-injector for opioid-overdose, made by Purdue Pharma. The agency granted de novo authorization for Labcorp’s PGDx elio plasma focus Dx used by labs for genetic profiling. As of 7 August, 950 AI/ML devices have been approved by the FDA. EKO Health teamed up with LSU to help detect arrhythmias and murmurs in student-athletes.
DHAC’s members, which span across multiple disciplines in the digital health industry, will hold their inaugural meeting this November.
The long-awaited TCET final notice doesn’t address major concerns, medtech industry advocates say.