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 2019 was nearly 20 years in the making across incremental changes to several related products. … Read More
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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 DOES get reported! See it all here. … Read More
Basil Systems Commercial Launchand 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 … Read More