Mauna Kea (ENT:MKEA) this week presented data from a study examining the use of its Cellvizio platform in assessing acute lung rejection following transplant. Data from the study was presented at the 2017 American Thoracic Society’s International Conference. The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at […]
Mauna Kea Technologies
FDA clears Mauna Kea’s Cellvizio Confocal miniprobes
Mauna Kea (ENT:MKEA) said today it won 510(k) clearance from the FDA for its Confocal miniprobes designed for use with the company’s Cellvizio platform. The newly-cleared Confocal miniprobes are indicated for use in urological and minimally invasive surgical applications along with the near-infared Cellvizio platform, Mauna Kea said. The company touted the regulatory win as its […]
Skyline Medical CEO Kornberg steps down, Schwartz takes over as interim | Personnel Moves May 20, 2016
Skyline Medical CEO Kornberg steps down, Schwartz takes over as interim chief exec Skyline Medical said earlier this month that prez and CEO Joshua Kornberg has stepped away from his roles at the company, and is being replaced by Carl Schwartz who will serve as interim chief executive. Prior to his time at Skyline, Schwartz served […]
Mauna Kea inks research collab deal with EM Imaging
Mauna Kea (ENT:MKEA) said yesterday it inked a research collaboration deal with Edinburgh Molecular Imaging to explore the combination of EM Imaging’s in vivo optical imaging agents with Mauna Kea’s confocal laser endomicroscopy platform to diagnose cancer. EM Imaging said it will supply optical imaging agent EMI-137 to 2 investigational sites to perform clinical efficacy studies […]
Mauna Kea expands Fujifilm deal in China
Mauna Kea (ENT:MKEA) said yesterday that it expanded a deal with Fujifilm Holdings (TSE:4901) to commercialize its Cellvizio laser endomicroscope in China. The deal calls for Japan’s Fujifilm to commercialize Cellvzio for gastroenterological and pulmonary applications in the People’s Republic, and integrate the device into its own endoscopes. Cellvizio 1st won approval from Chinese regulators in late 2012. “This […]
Ex-Insulet chief DeSisto out before he’s in at MannKind | Personnel Moves
MannKind Corporation said today it withdrew an offer that would have made ex-Insulet (NSDQ:PODD) CEO Duane DeSisto its new CEO only 19 days after officially posting its offer to DeSisto. The offer was withdrawn as objections were raised by DeSisto’s former employer Insulet, who said the new position would violate its non-competition agreement, which will be […]
Mauna Kea inks global commercialization deal with Cook Medical
Mauna Kea (ENT:MKEA) said today it inked a global commercialization partnership deal with Cook Medical for urology applications of its Cellvizio platform. Cellvizio is a confocal laser endomicroscopy system that provides images of cells and, in current implementations, helps doctors diagnose cancers of the stomach, oesophagus and bile ducts, Mauna Kea said. “We’re extremely pleased to partner with […]
Mauna Kea looks to Medtronic, Stryker, others for help in commercializing Cellvizio
Mauna Kea (ENT:MKEA) founder & CEO Sacha Loiseau is looking to some of the biggest names in medtech for help in commercializing its Cellvizio device in the U.S. after winning 510(k) clearance from the FDA last month. Paris-based Mauna Kea could ink a deal by the end of the year that would allow it to speed Cellvizio to market […]
Mauna Kea wins FDA 510(k) for Cellvizio
Mauna Kea (ENT:MKEA) said yesterday its Cellvizio confocal laser endomicroscopy platform won FDA 510(k) clearance for use during surgical procedures for treating multiple types of cancer. The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level, Mauna Kea said “This is a historic regulatory and business […]
Mauna Kea wins CE Mark for Cellvizio 800
Mauna Kea (ENT:MKEA) said today it won CE Mark approval in the European Union for its Cellvizio 800 near-infrared platform for endomicroscopic navigation during minimally invasive surgery. The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level, Mauna Kea said. The device is now indicated for […]
NuVasive shuffles the deck | Personnel Moves
NuVasive Inc. (NSDQ:NUVA) announced a flurry of new executive assignments yesterday as it reorganizes its leadership team under new CEO Gregory Lucier, who took over the position in May from ousted Alex Lukianov. NuVasive 14-year vet Pat Miles will stay on as COO and president, a position he was appointed to earlier this year, NuVasive said. […]