Mazor Robotics Ltd. (TASE:MZOR) unveiled its new Renaissance device, the next generation of its spinal robotic surgical guidance systems technology, which extend potential applications to more complex spine surgeries.
The new system is built on the core of the previous generation SpineAssist technology, which has been successfully used in more than 2,000 surgeries worldwide, accurately placing more than 12,000 implants, according to company officials.
The Israel-based company also touted positive findings from a 14-site international multicenter study published in the journal Spine, which showed that Mazor robotics technology "offers enhanced performance in spinal surgery when compared to freehand surgeries, by increasing placement accuracy and reducing neurologic risks," according to the release.
The Renaissance device features a new design and human interface, and well as updated hardware and software. The upgrades are designed to increase safety as well as extend potential surgical applications for the robot. The last generation could accomplish spinal fusions and scoliosis corrections, but the new generation can assist in osteotomies and implant placements.
Renaissance also serves as a platform that will support future clinical applications, such as robotic-guided cranial surgeries, according to the release.
The Renaissance systems already have U.S. regulatory clearance as well as CE Mark approval in the European Union. The company closed a $6.3 million PIPE funding round in February.
Masimo Corp. (NSDQ:MASI) announced limited release of its single-patient-use ear sensor, the industry’s first according to the release. The device detects oxygen saturation changes in the blood using the ear as an alternative to a finger sensor. The device already boasts 510(k) clearance and CE Mark approval in the European Union.
The launch is welcome news for the Irvine, Calif.-based company, which is currently mired in a proxy challenge regarding its executive compensation package.
STAAR Surgical Company (NASDAQ: STAA) touted two regulatory approvals last week. The company landed CE Mark approval for its KS-SP acrylic intraocular lens, as well as Brazilian marketing approval for its Visian implantable Collamer lens. The Monrovia, Calif.-based company plans to launch both new products during the second half of 2011.
Medisafe 1 Technologies Corp. (OTCBB:MFTH) a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced that it is in the process of submitting three new patents for medical safety devices. The first prevents products from leaving inventory storage without authorization, the second is a new locking mechanism for syringes and capsules, and the third is a physical lock that measures release of prescribed dosages to prevent over-dosing. The company secured a $5 million equity investment with Centurion Private Equity, LLC in April.
Pathway Medical Technologies Inc. announced U.S. regulatory clearance for its Jetstream Navitus catheter for treatment of peripheral vascular disease. The device is now available for sale in the U.S., according to the release.
ArthroCare Corp. (NSDQ:ARTC) announced U.S. Food & Drug Administration clearance for its Spartan 6.5 needled anchor, a preloaded threaded anchor for fixation of soft tissue to bone. The Spartan 6.5 is intended for open repairs, whereas its non-needled cousin, which received FDA clearance in October 2010, is intended for arthroscopic repairs.
3Disc, a computed radiography solution maker, touted 510(k) clearance for its FireCR medical scanners and QuantorMed imaging software. The company’s CR scanners and software can be quickly upgraded in the field without having to replace equipment, according to company officials.
Nico Corp. announced that it received approval to market its Myriad brain tumor removal system in Canada. Myriad is a fully automated neuro and spinal tissue removal device about the size of a pencil, which allows surgeons to operate through a narrow opening, and operating without using heat or ultrasonic energy that can potentially damage nerve structures. The device won FDA clearance in 2009 and CE Mark in April.
Datascope Corp. and Maquet Cardiovascular LLC announced a voluntary field correction for their S98/98XT, CS100/CS100i and CS300 balloon pumps, a move that affects nearly 1,300 customers worldwide. Pumps manufactured between May 2008 and December 2010 may have an affected power supply, or may have received one during a service upgrade in the field. In specific units, the fan assembly in the power supply might have a misshapen retaining ring, which could disengage with the fan and cause the assembly to stop rotating.
This looks like a bad year for Maquet, which underwent Class 1 FDA recall for some of its Heartstring II proximal seal systems in April.