Newly published data from SI-Bone's (San Jose, California) INSITE (Investigation of Sacroiliac Fusion Treatment) trial support the use of the firm's implant in patients. Results from the prospective multi-center randomized trial were published in the International Journal of Spine Surgery (IJSS), a peer-reviewed, PubMed-indexed journal and official journal of International Society for the Advancement of Spine Surgery (ISASS;Aurora, Illinois) .
In what can only be described as a dramatic setback for the company, GI Dynamics (Lexington, Massachusetts/ Sydney, Australia) is reporting that the FDA has placed a hold on enrollment in the firm's ongoing pivotal clinical trial of EndoBarrier Therapy. The hold comes after there were four cases of a bacterial infection of the liver or hepatic abscess reported in the ENDO Trial. Upon the news, stock from the company plummeted.
ATLANTA — If there's one thing that's for certain, it's that eventually things will change. Panelists at the Society of Interventional Radiology (SIR; Fairfax, Virginia) spoke about change, particularly in healthcare and what players in the space can expect.
ATLANTA — An interventional radiology treatment for migraines is garnering significant interest and attention after research from a retrospective study was presented at the Society of Interventional Radiology's (Fairfax, Virginia) Annual Scientific meeting this week.
ATLANTA — 3-D printing could offer up a more viable method of delivering medication over traditional devices according to a study that was presented at the Society of Interventional Radiology's Annual Scientific Meeting this week. Researchers and engineers collaborated to print devices that were bioactive.
ATLANTA — Just how is interventional radiology thriving in countries whose healthcare systems measure quality and outcomes as a way to control costs? A panel at this year's Society for Interventional Radiology (SIR) meeting held in Atlanta tackled this point head on as radiologists from across the globe spoke on regulatory issues and reimbursement barriers.
Aethlon Medical (San Diego), a company that specializes in developing targeted therapeutic devices to address infectious diseases and cancer, said that the first patient enrolled in the company's FDA approved feasibility study has completed their full Hemopurifier treatment protocol without any device-related adverse events.
A couple of weeks ago I had the opportunity to interview a company that was undergoing a pivotal trial in the U.S. The company had actually received approval from the FDA to use a second generation device in the trial - because the device was already approved in Europe and had been advanced to its second iteration. While this has been an issue for a while in the med-tech space - the fact that FDA can sometimes lag behind during the approval process to this degree is a bit troubling. To my mind it hampers innovation in the U.S....
