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

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

The recent recall of the Penumbra JET™ 7 reperfusion catheter came after 200 adverse events (AEs), including 14 patient deaths. The Class I device is intended to remove blood clots in the brain that cause stroke. The version of the product the FDA approved in...

When the global pandemic hit, the FDA authorized COVID-19 diagnostic tests to be rushed to market. When the FDA takes such an action through Emergency Use Authorizations (EAUs), no public records are available on the product’s regulatory application, efficacy, or safety profile. But, safety data...

What’s New at CDRH? A Different View. Are you ever curious about what parts of our industry keep CRDH busy? Or which medical disciplines are most active these days? At Basil, we believe these kinds of trends and insights are … Read More

Basil Systems is delighted to announce our SaaS platform for delivering essential healthcare insights is now commercially available. In addition, we secured $1.5M in venture capital funding to accelerate development and drive our initial market launch. Susan Alpert, a top … Read More