1. FirstRay wins FDA 510(k) clearance for extended Stealth staple line
FirstRay announced that it received FDA clearance for new additions to its Stealth Staple System product line, according to a March 15 news release. The company already had clearance for its standard size implants that were made from titanium alloy. The new clearance covers standard size implants manufactured from PEEK, small implants manufactured from titanium alloy and PEEK and Mini size implants made from titanium alloy.
2. CorVascular inks distribution deal with Novarix for IV-eye
CorVascular Diagnostics, a company that designs and distributes advanced peripheral vascular diagnostic solutions, announced this week that it has reached a distribution deal with Novarix, a company that makes innovative medical devices in Intravenous therapy, according to a March 15 news release. The Novarix-developed IV-eye is a near infrared vein imaging device that helps healthcare professionals find good veins for cannulation and venipuncture. CorVascular will market it IV-eye to national and large regional distributors and will introduce it to resellers in the healthcare segments in the U.S. markets.
3. Stryker wins tax break for $154M Michigan facility
Stryker Instruments announced that it has won a tax break from Portage, Mich., for its research and development facility plans in the city. Construction could begin as early as May, according to a March 15 news release. The facility is estimated to cost $154 million and be 485,000 sq. feet. The Portage City Council unanimously approved the tax break on March 14. The discount on the building will take effect upon completion in 2019.
4. Millar receives FDA 510(k) clearance for pressure catheter
Millar has won FDA 510(k) clearance for its Mikro-Cath pressure catheter, according to a March 14 news release. The 510(k) adds on to previous clearance that the Mikro-Cath received for its use in cardiovascular pressure monitoring and gave greater access to its MEMS pressure sensor for medical providers and researchers. The new clearance allows for it to be used for monitoring intracompartmental and airway pressures. The Mikro-Cath can be used during exercise studies for compartment pressure measurements because it is not affected by patient position or movement.
5. Avita receives Australian grant
Avita Medical announced that it received a Research and Development Tax Incentive cash rebate from the Australian Tax Office, according to a March 15 news release. The cash rebate totaled $974,908 Australian dollars ($751,293.35 in U.S. dollars) for the financial year that ended on June 30, 2016. Research and development tax incentives give tax cash rebates to support Australian companies that are participating in research and development projects.
6. Innovative Cardiovascular Solutions launches embolic protection
Innovative Cardiovascular Solutions announced this week that it had its first successful European clinical case for its Emblok embolic protection systems in patients that are undergoing TAVR procedures, according to a March 15 news release. The procedures were completed at the San Rafaela Hospital in Milan, Italy. TAVR is used in intermediate, high and extreme risk patients who have aortic stenosis and is currently being tested in low-risk patients. These procedures present a risk of neurological events because embolic debris can enter the cerebral, abdominal and distal vasculature during a procedure. The Emblok system is not yet available for sale and is only available for investigational use.
7. Amend Surgical signs license agreement for artificial bone
Amend Surgical signed an exclusive agreement with the University of Florida Research Foundation for the development of the artificial bone substitute, the Biomimetic Bone, according to a March 14 news release. Researchers at the University of Florida developed a process that mineralized collagen substrates with a polymer-induced, liquid-precursor process to create an artificial bone substitute that has the same composition and structure of natural bones. Because of this process, Amend Surgical will be able to create a highly mineralized, load-bearing, bioresorbable, collagen-hydroxyapatite composite that the company claims will be a pioneer in artificial bones.