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Mauna Kea's Next-Generation Cellvizio Platform Receives FDA Clearance, CE Marking
The new platform includes significant improvements and will enable major innovations, such as integrating easily with robotic systems.
Business Wire
05.13.20
FDA Clears Mauna Kea's Cellvizio Needle-Based AQ-Flex 19 Confocal Miniprobe
Product is cleared for use with transbronchial needles through existing bronchoscopes and bronchoscopic accessories.
Business Wire
04.09.19
Mauna Kea Obtains FDA Clearance for Applications of Cellvizio Confocal Laser Endomicroscopy
Product provides unique response to unmet needs during brain and spinal surgeries.
Business Wire
07.09.18
Patient Monitoring
Cook Medical’s Cellvizio Receives Further 510(k) Clearance
Cellvizio can now be used for in vivo imaging of the internal microstructure of tissues.
Business Wire
03.20.18
Mauna Kea Technology Appoints 30-Year Healthcare Executive to its Board
Newest member currently serves as chief commercial officer of Proteus Digital Health.
Mauna Kea Technologies
02.09.18
Mauna Kea Receives 14th FDA Clearance for the Cellvizio 100 Series
Approval validates the technology’s ability to image the internal microstructure of tissues, company claims.
Business Wire
01.19.18
Mauna Kea Technologies Appoints Deputy CEO and Chief Financial Officer
New executive brings nearly 20 years of finance, accounting and operational experience to the company.
Mauna Kea Technologies
11.03.17
Cellvizio Now CE Marked for Use During Robotic-Assisted Surgery
Regulatory milestone positions product as a key technology to enhance surgical robotics.
Mauna Kea Technologies
10.30.17
Surgical
Cellvizio CE Marked for Use During Robotic-Assisted Surgery
Company passes key regulatory milestone on product roadmap, positioning Cellvizio as an enhancement for surgical robotics.
Mauna Kea Technologies
10.09.17
Mauna Kea Receives Specific FDA 510(k) Clearance to Use Cellvizio During Robotic-Assisted Surgery
Key milestone in the Cellvizio product development roadmap, moving closer to data-driven surgery.
Business Wire
08.16.17
Surgical
FDA Clears Robotic-Assisted Surgery Device for Optical Biopsy
Key milestone in the Cellvizio product development roadmap, moving closer to data-driven surgery.
Business Wire
08.08.17
Mauna Kea Appoints Noted Gastrointestinal Cancer Specialist to Board of Directors
Leading surgical oncologist and GI specialist to add clinical expertise.
Business Wire
03.24.17
Mauna Kea Technologies Appoints Chief Operating Officer
Appointment strengthens company's global leadership team.
Business Wire
02.10.17
Expanded CE Mark for Mauna Key’s Cellvizio System
Product received FDA 510(k) clearance last year.
Videos
R&D & Design
Mauna Key’s Cellvizio Achieves Expanded CE Mark (Includes video)
Product received FDA 510(k) clearance last year.
09.07.15
R&D & Design
Mauna Kea Technologies Receives FDA Clearance for New Cellvizio System
New product expands possibilities for microscopic imaging inside the human body.
11.28.14
Breaking News
ConKay Medical Systems Raises $1.8 Million in Seed Funding
Owlet's Dream Sock OTC Infant Pulse Oximeter OK'ed in Europe
HeartBeam Begins Study of its AIMIGo System
Baxter Reports Q1 Results; Raises Full-Year Guidance
Brent Lang Named to Outset Medical's Board of Directors
View Breaking News >
CURRENT ISSUE
May 2024
Partner Preference in Full-Service Medical Device Outsourcing
Spot Check: A Discussion of the In-Vitro Diagnostics Market
Innovative Iteration for Medical Device Design
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