The FDA warned of a Covidien ventilator that may not deliver enough air, and another one from Dräger Medical that has faulty batteries. The ongoing corrective actions of about 2,700 units of the devices have been deemed Class 1, a designation reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
None of the giant med tech acquisitions that have closed recently have resulted in a reduction in employee count yet. Not Medtronic-Covidien, Zimmer-Biomet, nor Becton Dickinson-CareFusion. But the rumors are already swirling on where all the anticipated cost savings and reduduncies will be found. That's according to the latest jobs data from EP Vantage.
The latest data from Medtronic demonstrate just how wide its market reach extends. It found that a recently approved adhesive treatment for chronic venous insufficiency is comparable to radiofrequency ablation via a device that it also markets. That makes it seem like a win-win for the medical device giant, which now offers two equivalent, but distinct, treatment modalities.
Medtronic's Covidien unit is settling more than 11,000 claims related to transvaginal mesh devices, months after a judge urged companies facing litigation over the products to resolve cases with plaintiffs rather than battling it out in court.
Medtronic announced a large voluntary recall of its Shiley neonatal and pediatric tracheostomy tubes is underway due to a wider angle bend among affected models than in those manufactured after Nov. 29, 2012. It has suspended shipments of the faulty tubes.
Medtronic's Covidien was hit with a recall of 1,661 units of its VenaSeal Sapheon Closure System, a procedural delivery system for an adhesive that treats venous reflux disease by closing the affected veins in the lower leg.
With the FDA approval of Covidien's VenaSeal closure system, medical professionals can for the first time treat varicose veins in the legs by using an adhesive to cut off blood supply.
Medtronic added 2% in early trading after it reported its first earnings since the close of the Covidien acquisition. Recent product launches across business groups helped push it to beat consensus earnings for the quarter by $0.04 at $1.01 and top revenue estimates at $4.32 billion versus the $4.26 billion expectation.
Groundbreaking studies offer more evidence that revascularization devices that physically remove blood clots from the brain are a valuable and potentially lifesaving addition to pharmaceutical therapy in stroke patients.
Medtronic scored its first new FDA approval resulting from the acquisition of Covidien, which closed less than two weeks ago. The nod is for Pipeline Flex, a next-generation minimally invasive flow diversion device for unruptured aneurysm. It comes from Covidien's fast-growing, but tiny, neurovascular group.