Cochlear Ltd., of Sydney, received U.S. FDA approval for its Nucleus Profile Plus cochlear implant and the Nucleus 7 sound processor's new built-in connectivity, enabling direct streaming with compatible Android smartphones. The implant will be commercially available in the U.S. later this month.

Netanya, Israel-based Theranica Bioelectronics Ltd., which is focusing on the development of advanced electroceuticals for migraine and other pain disorders, scored a win at the U.S. FDA, with the agency granting its de novo request for the smartphone-controlled Nerivio Migra.

The FDA has granted de novo approval to 23andme Inc. for its report on BRCA1 and BRCA2 risk for developing breast, prostate or ovarian cancer. The direct-to-consumer (DTC) saliva test can provide insight on three genetic mutations linked to the cancers, most commonly found in patients of Eastern European, or Ashkenazi Jewish heritage, which account for a relatively small portion of patients. There are more than 1,000 mutations of the BRCA gene, and the test is not intended to diagnose or rule out the presence of mutation, or increased risk of the particular cancers due to other factors.

Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA, making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.

The number 23 is an interesting number. It’s a prime number, and is the number of pairs of chromosomes in human DNA, but it may also become a number FDA won’t soon forget. FDA recently issued a warning letter to 23andMe, ordering the company to stop offering its gene testing service pending further evaluations of the tests. Then a petition popped up at the website for the White House to require FDA to back off. The petitioners argue the agency “grossly overstates the risks” associated with the test, adding that consumers understand those risks. I won’t pretend to know what...

The MedTech Investing Conference held each May in Minneapolis is one of the more interesting investor-focused gatherings on the calendar. It always earns accolades from attendees as representing one of the best opportunities to bring together venture capitalists, entrepreneur/innovators and corporate development types, the latter of whom are always happy to spread the message that they’re open for business. Held for the 12th year earlier this month, the conference offered quite the reminder of the range of emotions being felt these days by those involved with or interested in med-tech. During his welcoming comments, conference co-chairman Kevin Wasserstein, founder and principal...

In a recent issue of Medical Device Daily, Integrity Life Sciences (ILS; Tampa) reported that FDA will investigate the use of robotic surgery, a move said to be sparked by a tripling of adverse events reports between 2008 and 2012. The company statement indicates that the more than 1,400 U.S. hospitals deploying surgical robots have filed enough reports to render a report rate that is a "higher than acceptable rate," although the announcement acknowledges that the data do not clearly disclose whether "the failure is attributable to the robot itself, operator error, the FDA marketing clearance process, or the training...

Charles Dickens at his desk in 1858. Dickens' famous opening line from "A Tale of Two Cities" could easily be applied to the current state of the medical device industry, "It was the best of times, it was the worst of times." Here at Medical Device Daily we've become accustomed to the doom-and-gloom stories about our industry. The medical device tax provision in the Affordable Care Act and other emerging realities of healthcare reform along with worldwide economic sluggishness, regulatory and reimbursement challenges, consolidation among hospitals and an increase in hospital-employed physicians has created the perfect storm for the medical device industry....

ATLANTA - With a substantially strong turnout the Southeastern Medical Device Association (SEMDA) kicked off its 2013 conference earlier today. Hosted at the Georgia Institute of Technology Global Learning Center, the organization's annual conference featured speakers ranging from Medical Device Manufacturers Association President/CEO Mark Leahey to Jeff Shuren, MD, director of the Center for Devices and Radiological Health (even though he was speaking from an offsite location). SEMDA seemed to have its finger on the pulse of med-tech firms' concerns even more so than last year. As in past years the themes seemed to center around dealing with strained funding...