Author Archives: Kaitlyn Bricker

A map of predicate devices for a 510(k) medical device application that was submited to the FDA. This predicate map i sof a Roche Diagnostic Heart Failure product and displays two predicates and one reference device. This was pulled from Basil Systems.

Navigating the 510(k) & De Novo Ecosystems – Predicate Mapping

https://basilsystems.com/wp-content/uploads/2021/11/RAPS-Webinar-Hauser-excerpt-v1.mp4 The Ecosystem Explained:  Basil Systems Ecosystem is a predicate mapping feature for 5(10)k and De Novo devices to showcase their predicate history and relationship to other cleared devices.  To access a devices ecosystem you must first use the natural … Read More

Gaining a Competitive Edge with Basil Systems

Medical device markets are complex, fast-moving, unforgiving – and very competitive. For a company spearheading innovations in the field of transcatheter valves, understanding the competitive landscape was crucial. Other companies had products on the market, each with different designs and … Read More

A map of predicate devices for a 510(k) medical device application that was submited to the FDA. This predicate map i sof a Roche Diagnostic Heart Failure product and displays two predicates and one reference device. This was pulled from Basil Systems.

Optimizing Regulatory Strategy & Dissecting Emerging Therapies

It’s an unfortunate reality that promising med-tech innovations can be undermined by the complexities of the regulatory clearance process. For one visionary company intent on pioneering early-stage heart failure (HF) diagnostics, their quest was twofold: to efficiently navigate the web … Read More