07:00 , May 5, 2014 |  BC Week In Review  |  Clinical News

Cellvizio regulatory update

Mauna Kea said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Cellvizio optical biopsy device for use in endoscopic procedures, including gastrointestinal, urologic and respiratory indications. Cellvizio is a probe-based, confocal laser endomicroscopy system...
07:00 , Mar 17, 2014 |  BC Week In Review  |  Clinical News

Cellvizio regulatory update

Mauna Kea said FDA granted 510(k) clearance for Cellvizio optical biopsy device for use during urological procedures within anatomical tracts, including the urethra, bladder and ureter. The clearance covers the use of Cellvizio's Uroflex B...
08:00 , Jan 14, 2013 |  BC Week In Review  |  Clinical News

Cellvizio regulatory update

Mauna Kea said the Centers for Medicare and Medicaid Services (CMS) approved a reimbursement rate of $520 for the use of Cellvizio optical biopsy device during endoscopy procedures in the upper GI tract. The American...
08:00 , Dec 17, 2012 |  BC Week In Review  |  Clinical News

Cellvizio regulatory update

Mauna Kea said China's State Food and Drug Administration (SFDA) approved Cellvizio optical biopsy device for gastrointestinal and pulmonary use. The biotech also said it partnered with the Fujifilm (China) Investment Co. Ltd. subsidiary of...
08:00 , Dec 3, 2012 |  BC Week In Review  |  Company News

Mauna Kea, University of Edinburgh, University of Utah deal

Mauna Kea partnered with the University of Edinburgh to add molecular imaging capabilities to Mauna Kea's Cellvizio optical biopsy device for diagnosing and monitoring patients with pulmonary diseases. The partners will develop the university's...