1. OrthoCell inks Australian distro deal
Orthocell announced in an Oct. 10 press release that it has signed a distribution deal with Surgical Specialities. The deal will make Surgical Specialities the exclusive distributor in Australia and New Zealand for Orthocell’s cell therapies for tendon regeneration and cartilage regeneration. Surgical Specialties is set to take over distribution responsibilities of the Ortho-ATI and Ortho-ACI systems for the next five years.
2. Viveve wins Taiwanese clearance for Viveve system
Viveve Medical has won regulatory approval in Taiwan for its Viveve System, according to an Oct. 10 press release. The approval allows the company to market their system in Taiwan for general surgical procedures for electrocoagulation and hemostasis.
3. Faxitron wins FDA nod for radiographic imager
Faxitron announced in an Oct. 10 press release that it has won FDA 510(k) clearance for its VersaVision digital imaging system. The imaging system is designed to help create better precision and workflow in clinical settings. It is used for radiographic imaging of core biopsies and surgically excised specimens.
4. Bonesupport launches Cerament trial
Bonesupport has entered its first patient into its study for its Cerament G and Cerament V bone substitutes, according to an Oct. 9 press release. Cerament G and Cerament V are designed to be used in patients who are going through hip and knee arthroplasty revisions. The study is expected to have about 135 patients and will evaluate the effectiveness and safety of Cerament G and Cerament V when filling bone defects in the tibia, femur shaft or acetabulum.
5. Alcon gets CE Mark for pre-loaded IOL
Alcon announced in an Oct. 6 press release that it has received CE Mark for its Clareon IOL with AutonoMe delivery system. AutonoMe is an automated, disposable, pre-loaded IOL delivery system that helps deliver the IOL into the capsular bad in patients having cataract surgery. The Clareon system has an automated CO2 powered delivery mechanism and an ergonomic design to allow for precise and simplified single-hand control of IOL placement.
6. Masimo launches Trace data visualization tool
Masimo announced in an Oct. 5 press release that it has launched its Trace patient data visualization and reporting software for Masimo Root and Radical-7 monitors. Trace has the full capabilities of the Masimo Root Patient Monitoring and Connectivity Platform, including Radical-7 and Radius-7 Pulse CO-Oximeters. Trace helps add visualization resource to clinical toolkits. It is customizable and can communicate with other devices through high-speed wired or wireless connections and has the ability to download 96 hours of patient data in seconds.
7. CorNeat unveils artificial cornea
CorNeat Vision announced in an Oct. 6 press release that it has completed the design and development stage of its cornea implant, the CorNeat KPro. After completing biocompatibility and safety tests, the company hopes to implant it in humans by mid-2018. The CorNeat KPro uses advanced cell technology to integrate artificial optics in resident ocular tissue.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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