It has been a couple of challenging years for drugmaker Hospira. FDA issued a Class I recall of Hospira- and Abbott-branded infusion pumps because of broken door assemblies, reports Qmed.com. It's at least the sixth time since the start of 2013 that the company has been the subject of a Class I recall. The faulty assembly could result in serious death or injury because it could lead to overinfusion or delay of therapy.
Apple's medtech spree
For a company that is secretive to a fault, Apple has a knack for getting media attention. It made several headlines the last few days, spurred by a feature from Reuters, "Apple on medical tech hiring spree, a possible hint of of iWatch plans." The article summarizes "a year's worth of our reporting here at 9to5Mac," sniffed the Apple intel website. Nevertheless, news about Apple luring experts in medical sensing into its ranks further fueled an Internet media feeding frenzy.
"New reports of Apple's medtech hiring suggest accelerating interest in health monitoring, adding to rumors that the company is working on biomarker trackers for the the long-rumored "iWatch" and sensors that may be able to predict heart attacks, wrote MassDevice.com. "That may spell a shakeup in mHealth, should Apple decide to compete with existing players."
Recent hires include former Masimo Chief Medical Officer Michael O'Reilly, who was with Masimo when it introduced the first Apple-approved pulse oximetry system; Nancy Dougherty, formerly involved with transdermal drug delivery devices and wearable vital signs monitoring at Sano Intelligence; Ravi Narasimhan, who worked with personal vital signs monitoring at Vital Connect; Nima Ferdosi, an embedded systems expert who also worked at Vital Connect; and Marcelo Lamego, Chief Technology Officer at Cercacor, a former Masimo subsidiary still run by Masimo CEO Kiani, reported MassDevice.com.
Teleflex plans layoffs
Medical device manufacturer Teleflex (Wayne, PA) announced that it would cut jobs and close plants as part of a restructuring plan. The company did not reveal the details of the plan, but said that it expects to save $28 million to $35 million annually once the plan is fully implemented with some savings kicking in as early as next year, reported Arundhati Parmar, Senior Editor at sister publication, MD+DI.
FDA may reclassify surgical mesh kits
The FDA is considering reclassifying surgical mesh kits, designed to treat pelvic organ prolapse, from Class II to Class III medical devices. The proposal, which is up for comment for 90 days, would subject the products to the FDA's premarket approval program and would require companies to provide safety data even for kits already on the market. Most kits on the market were approved through the 510(k) process, which expedites review for devices that are substantially equivalent to other devices on the market.
The agency has been investigating cases of serious complications associated with transvaginal mesh kits since 2008, reports the Wall Street Journal. Complications include shrinking and movement of the mesh, causing significant and chronic pain, in some cases. Thousands of lawsuits have been filed. Johnson & Johnson's Ethicon and Boston Scientific are among the major manufacturers of mesh kits.
German healthcare group Fresenius blamed a strong euro and spending cuts in the United States for an underperforming Q1 earnings report. Company subsidiary Fresenius Medical Care, the world's largest kidney dialysis provider, fared especially poorly, with a 9% decline in net income, according to Reuters. While year-on-year turnover increased by 7%, earnings before interest and taxes fell 8%, notes sister publication emdt. Despite the spotty start, CEO Ulf Mark Schneider said the company is "fully on track to achieve growth targets for 2014."
And that was the medtech week that was.