Si-Bone said today it won FDA 510(k) clearance for its 3D-printed titanium iFuse-3D implant designed for fusion procedures to treat certain disorders of the sacroiliac joint. The San Jose, Calif.-based company said that the iFuse-3D is the 1st ever 3D-printed titanium implant designed for use in the sacroiliac joint. The company developed it using proprietary […]
Si-Bone wins US Military Tricare coverage for iFuse
Si-Bone said today that the US Military’s Tricare program has established a written coverage policy for minimally invasive sacroiliac joint fusion surgeries, including those using its iFuse implant system. The iFuse implant system is a triangular shaped minimally invasive surgical device designed for spinal fusion procedures to treat certain disorders of the sacroiliac joint, the San […]
7 medtech stories we missed this week: April 28, 2017
From FDA and Health Canada approvals to joint ventures, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device […]
Si-Bone touts 6-year iFuse data
Si-Bone today released data from a 6-year study of its iFuse Implant, touting significant reduction in opioid use for pain control in patients treated with the device. Data from the study, which compared the iFuse implant to both conservative management and radiofrequency denervation for treating SI joint pain, was published in the journal Neurosurgery. The iFuse […]
Si-Bone launches iFuse warranty program
Si-Bone said today it launched an iFuse warranty program which will supply patients with a free iFuse Implant to supplement or replace previously placed iFuse implants within a year if revision surgery is required. The iFuse implant system is a triangular shaped minimally invasive surgical device designed for spinal fusion procedures to treat certain disorders […]
Si-Bone wins Nebraska BCBS coverage for iFuse implant system
Si-Bone said today Blue Cross Blue Shield of Nebraska updated its medical policy to provide coverage for minimally invasive SI joint fusion procedures. The move makes BCBS of Nebraska the 2nd BCBS plan, following BCBS of Michigan, to approve a positive coverage policy for MIS SI joint fusion procedures, San Jose, Calif.-based Si-Bone said. “BCBS of Nebraska joins BCBS […]
Si-Bone’s new CCO is ex-Baxano CEO Recupero | Personnel Moves July 6, 2016
Si-Bone’s new CCO is ex-Baxano CEO Recupero Si-Bone said yesterday it tapped ex-Baxano (NSDQ:BAXS) CEO Tony Recupero as its new chief commercial officer. Prior to moving to Si-Bone, Recupero served as president of medical device and diganostic commercialization strategy company Catalyst Performance Advisors and CEO of Baxano Inc, as well as other executive positions in the […]
Si-Bone raises $20m for iFuse spine implant
UPDATED June 20, 2016 with comment from Si-Bone, investor details. Si-Bone said June 17 that it raised a $20 million funding round, hot on the heels of the regulatory and reimbursement wins it logged last week. Nine investors participated in the equity round, San Jose, Calif.-based Si-Bone said in a regulatory filing; in a June 20 press release, the […]
Si-Bone touts updated 510(k) clearance indications, MAC reimbursement wins for iFuse
Si-Bone said this week it won updated 510(k) clearance indications for its iFuse implant system and reimbursement coverage for its minimally invasive surgery sacroiliac joint fusion systems through Medicare Administrative Contractor FCSO. Si-Bone said the FDA modified the indication statement for its iFuse sacroiliac joint fusion system to include that clinical studies have demonstrated that treatment […]
Si-Bone touts maintained results at 2 years in iFuse study
Si-Bone this week released 2-year results from the SIFI trial of iFuse implant system designed for sacroiliac joint fusion procedures, touting improvements in quality of life and a 28% reduction in opioid use. Results from the trial were published in The International Journal of Spine Surgery, the San Jose, Calif.-based company said. The 172-patient multi center […]
Si-Bone expands European footprint, adds 2 new execs
Si-Bone said today it is expanding its European presence by forming Si-Bone UK Ltd. and bolstering the executive team for its European, Middle East and Africa businesses. Si-Bone said it tapped Richard Moss as its new U.K. & Ireland GM, leading all operations of its newly formed SI-Bone U.K. division. The company also picked up […]
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