Penumbra said today that it has received 510(k) clearance from the FDA for its Ace64 aspiration thrombectomy device, based on data from the Mr. Clean trial and additional randomized controlled stroke trials.
CareFusion said it’s recalling all of its Avea ventilators over a possible pressure transducer failure that may cause the units to stop functioning.
VertiFlex said today that it won pre-market approval from the FDA for its Superion interspinous spacer for treating moderate lumbar spinal stenosis.
The husband-and-wife team that founded the company that eventually became Alere Analytics bought the business back and rebranded it as Persivia. Financial terms were not disclosed. Persivia CEO Mansoor and chief medical officer Dr. Fauzia Khan in 2012 sold DiagnosisOne to Alere, which the next year renamed it as Alere Analytics, before deciding to sell […]