Endologix’s Nellix stent graft passes early safety bar
FDA down-classifies Ergon Medical’s Prolong PE device
Ventripoint wins expanded FDA indication, seeks $700k
Penumbra wins FDA nod for Ace64 thrombectomy device
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.
Imris files for Chapter 11 bankruptcy
Imris Inc. (TSX:IM) said today that it and 2 subsidiaries, including its NeuroArm Surgical business, filed for Chapter 11 bankruptcy protection.
FDA: CareFusion’s Avea ventilator recall is Class I
CareFusion said it’s recalling all of its Avea ventilators over a possible pressure transducer failure that may cause the units to stop functioning.
Report: Medtronic looks longingly at China
VertiFlex wins FDA nod for Superion spine device
VertiFlex said today that it won pre-market approval from the FDA for its Superion interspinous spacer for treating moderate lumbar spinal stenosis.
Mela Sciences recalls MelaFind
Mela Sciences (NSDQ:MELA) recalled its flagship MelaFind melanoma diagnosis aid because some of its software wasn’t included in its pre-market approval from the FDA.
Founders buy back Alere Analytics, rebrand as Persivia
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 […]