Mauna Kea (ENT:MKEA) this week said it won FDA clearance and CE Mark approval for its next-generation Cellvizio endomicroscopy platform. The Cellvizio uses modular design solutions to better integrate endomicroscopy in procedure suites and third-party platforms. The new platform was designed to facilitate future developments that include deep learning capabilities for assisted image interpretation. It’s also […]
FDA clears Mauna Kea Technologies system for lung cancer detection
Paris-based Mauna Kea Technologies (ENT:MKEA) said that it has received 510(k) clearance from FDA for the use of the Cellvizio AQ-Flex 19 Confocal Miniprobe through existing bronchoscopes, transbronchial needles, and other bronchoscopic accessories to detect lung cancer. Cellvizio is a multidisciplinary probe-based and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform designed to aid clinicians in the diagnosis and treatment […]
Mauna Kea, Cook Medical terminate Cellvizio dev, distro deal
Mauna Kea (ENT:MKEA) said today that it and Cook Medical have mutually decided to terminate their development and distribution agreement. The deal, originally inked in late 2015, included the development of Mauna Kea’s Cellvizio confocal laser endomicroscopy systems for urologic applications. Paris-based Mauna Kea said that it agreed to develop a private-label version of the Cellvizio […]
7 medtech stories we missed this week: May 25, 2018
From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance […]
Medtronic taps Harvard cardiologist Mauri for clinical research VP | Personnel Moves – April 10, 2018
Medtronic (NYSE:MDT) said last week it tapped Harvard Medical School professor and cardiologist Dr. Laura Mauri as its new vice president of global clinical research and analytics. In the new position, Dr. Mauri will direct dynamic global clinical research strategies as well as the development of novel analytical and data science solutions as the Fridley, Minn.-baesd […]
Mauna Kea wins expanded FDA 510(k) for Cellvizio
Mauna Kea (ENT:MKEA) said today it won expanded FDA 510(k) clearance for its Cellvizio confocal laser endomicroscopy platform and its Confocal Miniprobe devices. The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level. The system allows the operating physician to visualize the internal microstructure of tissue […]
Mauna Kea touts Cellvizio pancreatic cyst diagnosis study data
Mauna Kea (ENT:MKEA) today released data from a study exploring the use of the company’s Cellvizio system to diagnose pancreatic cysts, touting improved diagnoses and patient management. Results from the trial were presented at the United European gastroenterology Week 2017 meeting, the Paris-based company said. The Cellvizio device is designed for use in a variety of […]
MRI Interventions taps ex-Philips exec Burnett as prez, CEO | Personnel Moves – Oct 19, 2017
MRI Interventions (OTC:MRIC) said early this month it tapped former Royal Philips (NYSE:PHG) neuro diagnostics & therapy biz GM Joseph Burnett as its new prez & CEO, effective November 7. Burnett will replace Frank Grillo who will stay in his role until November 6 and will continue to serve as an executive advisor afterwards, the Irvine, Calif.-based […]
Cook Medical urology biz launches Mauna Kea’s Cellvizio
UPDATE: Corrected to reflect that the launch was global, and not limited to the US. Cook Medical said today its urology business has launched Mauna Kea‘s (ENT:MKEA) Cellvizio confocal laser endomicroscopy system, with a deal to distribute the device globally. The Cellvizio device is designed for use in a variety of surgical procedures, providing real […]
Mauna Kea wins FDA nod for CelioFlex Cellvizio miniprobes
Mauna Kea (ENT:MKEA) said today it won FDA 510(k) clearance for its CelioFlex UHD confocal miniprobes designed for use with its Cellvizio device in robotic-assisted surgery. The CelioFlex UHD probes are designed to provide visualization of body cavities, organs and canals during endoscopic, laparoscopic and robotic-assisted procedures, the Paris-based company said. “This new FDA clearance is […]
Mauna Kea touts Cellvizio pancreatic cyst diagnosis data
Mauna Kea (ENT:MKEA) today touted the results from a recently published study of its Cellvizio system which supported the use of the device in diagnosing pancreatic cysts. The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level, Mauna Kea said. Results from the study were […]
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