Global Approvals Snapshot August 2019
An overview of the global medical device approvals in September, as captured by Medtech Insight's Approvals Tracker. Approvals of several major cardiovascular devices highlighted what was otherwise a slow month for medical device approvals.
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FDA Approves CVRx’s Barostim Neo For Heart Failure On Expedited Pathway
The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.
FDA Expands TAVR Indication To Low-Risk Patients
As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.
News We’re Watching: Two Join Illumina Board, FDA Plans Health Equity Meeting, Pre-Eclampsia Test Cleared
This week, Illumina’s board added two independent members; the VA and the FDA agreed to collaborate on supply chain issues; and Think Surgical, Thermo Fisher Scientific and Blue Earth all landed FDA clearances.