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Latest From Reed Miller
Medtech Insight's Approvals Tracker reports 22 medical device approvals from outside the United States in November, including 12 CE marks from Europe, plus approvals from Taiwan, Singapore, Japan, India, Canada, Australia and Argentina.
Edwards Lifesciences exercised a 2015 option to buy Harpoon, a spin-off from the University of Maryland's School of Medicine, for $100m up-front and up to $150m more in milestones, to add Harpoon's beating-heart mitral valve surgery technology to its growing pipeline of transcatheter and surgical mitral valve repair and replacement devices. The deal also validates the investing approach of Epidarex Capital, one of Harpoon's early investors, which looks for early-stage medtech opportunities in the Mid-Atlantic states.
Results of a 1,617-patient trial, presented at the 2017 San Antonio Breast Cancer Symposium on Dec. 6, show Myriad Genetics' riskScore test, which combines data from the traditional Tyrer-Cuzick model with 86 single nucleotide polymorphisms can predict the five-year and lifetime risk of breast cancer compared to the Tyrer-Cuzick model alone.
Starts & Stops: Mercator Looking To Leap Into New Indications For Bullfrog Micro-Infusion Drug-Delivery
Starts & Stops is a regular feature highlighting Medtech Insight's monthly editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions. This month's edition, covering November, is led by a major milestone for Mercator Medsystems, developer of the Bullfrog micro-infusion catheter.
On this week’s podcast, we highlight an eye-opening study that shows that the chummier a device-maker is with US FDA investigators, the more likely it is that those firms will experience quality system troubles and face costly product recalls.
MedLumics appointed James Greene as its CEO and Giovanni Leo to the board of directors. The Madrid-based company expects the two industry veterans to carry it through the its next phase of growth – commercialization of the AblaView AF catheter.