Using Smartphone Apps to Power Clinical Research

BrainSpace is developing a closed-loop precision drainage system with wearable pressure monitoring that automates cerebrospinal fluid management for patients with conditions like traumatic brain injuries and hydrocephalus. Their team has completed the first-gen device and is currently preparing for FDA clearance, which is expected in 2025. In this interview, Caitlin Morse, the company’s CEO, shares her advice on assessing the viability of a medtech idea, tells the story of how her prototype won over stakeholders, and discusses navigating the development phase while balancing clinical and regulatory demands.

At Front Line Medical Technologies, Drs. Asha Parekh and Adam Power have spearheaded the development of COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System). This compact, minimally invasive device is designed for temporary aortic occlusion in trauma situations. In this interview, Asha and Adam discuss how their clinical-engineer partnership accelerated development, their approach to clinical studies for regulatory clearance across multiple geographies, and their strategic decision to avoid VC funding during early development—and how that decision paid off.

With Kelly Huang at the helm, Elucid has developed a platform that uses AI to analyze cardiac CT scans to provide a detailed, non-invasive assessment of a patient’s arterial plaque. Elucid’s PlaqueIQ offers the promise of cardiovascular risk prediction by providing doctors with lesion-level insights on plaque composition that may lead to patient-specific therapeutic decisions. In this interview, Kelly shares advice on how to bring novel devices to market, secure reimbursement, and drive adoption by focusing on the essentials—collaboration, trust, robust data, and transparency.