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...Read More
What’s really going on with COVID-19 EUA tests?
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...Read More
What’s New at CDRH?
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 MoreRead More
Basil Systems Commercial Launch and New Seed Funding
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 MoreRead More