The heated debate concerning the reauthorization of the Medical Device User Fees that has had the medical device industry on the edge of its seat for more than a year may finally be winding down. FDA announced this week that it had reached an agreement 'in principle' with industry that would allow FDA to collect higher user fees of $595 million over five years in exchange for new goals for time frames for PMA and 510(k) submissions. On the heels of this news, House Democrats introduced a bill...

Coin-sized disks cut from the cocoon of the tasar silkworm grub provide a basic scaffold for heart muscle cells. Image: MPI for Heart and Lung ResearchBecause damaged human-heart muscle cannot be regenerated, scientists from the Max Planck Institute for Heart and Lung Research (Bad Nauheim, Germany) are seeking to restore cardiac function with the help of artificial cardiac tissue. They report that they have succeeded in loading cardiac muscle cells onto a three-dimensional scaffold created...

In his State of the Union Address this past week, President Obama focused on the importance of reinvigorating American manufacturing and the need to better incentivize companies to stay or set up operations in the U.S. rather than shipping jobs and business overseas. And while the medical device industry applauded this general mentality, many were quick to point out that the impending medical device tax was among the key drivers of medtech operations moving abroad. In other news, the former...

Boston Scientific (Natick, MA) isn't exactly shrinking from recent criticism regarding instances of longitudinal stent deformation in its thin-strut Ion paclitaxel-eluting platinum-chromium (PtCr) coronary stent system. Instead, the medical device giant has posted an informative—though unlisted—video on YouTube titled, "Beyond the Hype: Longitudinal Stent Deformation," which emphasizes the rarity of longitudinal compression as well as the fact that all thin-strut drug-eluting stents are...

This week in medtech, experts began to ponder the potential impact that the French breast implant scandal could have on U.S. regulation. The industry and its supporters often point to the quicker device clearance process in the European Union (EU) when criticizing FDA, for example. But the controversy that has erupted from a company's breast implants that leaked industrial silicone into patients has provided FDA and its supporters with a sizeable stock of ammo. “All the industry guys in the U.S...

As it turns out, the concept of capsule endoscopy has been relatively easy for physicians and patients alike to digest. In fact, the innovative pill camera technology, pioneered by Given Imaging in 2001, has proven to be a less-invasive and effective means of visualizing and diagnosing conditions or problems in the small intestine. But while the underlying diagnostic technology offers indisputable advantages, the gut feeling of healthcare providers is that these patient-friendly devices should...

Microtweezers developed by researchers at Purdue University (Lafayette, IN) may facilitate the manufacture and assembly of microelectromechanical systems (MEMS). Capable of manipulating tiny structures, the microtweezers could contribute to the development of advanced sensors and may someday be suitable for working with live stem cell spheres in research settings as well.Purdue microtweezers can be used to assemble tiny polystyrene spheres, each with a diameter of 40 micrometers, at left, into...

Based on an open-source model, UCSC and the University of Washington are sending Raven II robots to several universities in order to accelerate research on surgical robots.Researchers at UC Santa Cruz (UCSC) and the University of Washington (Seattle) have built seven surgical robots—dubbed Raven II—for their own use and for use by five other medical research laboratories, including Harvard University (Cambridge MA), Johns Hopkins University (Baltimore), University of Nebraska (Lincoln), UC...

Qualcomm, renowned for its role in developing next-generation mobile technologies, wants to know if you have the X factor when it comes to innovative device design. Through its X Prize Foundation, the company has launched the $10 million Qualcomm Tricorder X Prize, a competition aimed at spurring the development of innovative consumer products that demonstrate the intersection of diagnostic technology and mobile platforms.Announced at the Consumer Electronics Show this week, the competition...