This article was originally published in Start Up
The explosion of new interventional cardiology procedures has triggered the growth of a new device niche, arterial puncture closure devices. BioInterventional Corp. has developed a technology that uses small discs deployed at the puncture site to facilitate hemostasis.
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After an initial warm welcome for first-generation femoral artery closure devices--including a few high-profile exits--sales have stalled. Early devices are flawed, indicating the technical challenge is tougher than it looks. A dozen or so start-ups are trying to address the technology problems that have hampered the pioneers. The newcomers face high hurdles as early experience with first generation devices temper clinician and investor enthusiasm. All will have to prove, in large, rigorous clinical trials, that devices are more complication-free and are as easy-to-use as market leader Angio-Seal, and that they're at least as safe, if not safer, than manual compression. But although start-ups face a great of skepticism about particular technologies, they also inherit a $350 million market made up of devices with an average selling price of $200, which is an endorsement of this new device market. At the same time, an enormous opportunity remains in the 75% of the market that remains unpenetrated.
The first generation less-invasive devices for abdominal aortic aneurysm (AAA) surgery haven't yet been approved and the next generation is already here.
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.