GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Signa Magnus MRI scanner. The 3.0T high-performance, head-only scanner offers new capabilities for both clinical imaging and neuroscience. It has the potential to aid in the detection of neurological, oncological and psychiatric conditions, according to a news release. Signa Magnus features what […]
510(k)
Magstim earns FDA clearance for transcranial magnetic stimulation that treats depression, OCD
Magstim announced today that the FDA cleared its next-generation Horizon Inspire system for delivering transcranial magnetic stimulation (TMS). Clearance paves the way for the use of the TMS technology to treat patients with major depressive disorder (MDD), obsessive-compulsive disorder (OCD) and anxious depression. Minneapolis-based Magstim designed Horizon Inspire to address physician needs with high-power air […]
Momentis Surgical wins FDA nod for second-gen surgical robot
Momentis Surgical (formerly Memic) announced today that the FDA granted 510(k) clearance for its second-generation Anovo surgical robot. Last month, Anovo received clearance for use in single-site, abdominal access across ventral hernia repair. It complemented Anovo’s existing approvals for natural orifice laparoscopic-assisted transvaginal benign gynecology procedures. Momentis said the system became the first and only FDA-authorized surgical […]
Zeta Surgical wins FDA nod for AI-powered surgical nav tech
Zeta Surgical announced that the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities. The FDA clearance applies to use with expanded instruments and enhanced hospital connectivity. This clearance comes less than a year after the Boston-based company got an FDA nod for expanded software functionality. Zeta Surgical’s mixed reality (MR) system initially […]
FDA clears SimBioSys clinical decision support tech for breast cancer surgery
SimBioSys announced that it received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons in the U.S. Chicago-based SimBioSys picked up an initial FDA clearance for the platform at the start of this year. The updated TumorSight Viz now processes images with AI in a matter of minutes. It […]
FDA clears Quanta home hemodialysis system
Quanta Dialysis Technologies announced today that it received FDA 510(k) clearance for the use of its dialysis system in the home. Beverly, Massachusetts–based Quanta said in a news release that the FDA nod makes it the only company offering a high dialysate flow (500 mL/min) system across the entire care continuum for end-stage renal disease […]
FDA clears Exactech porous 3D tibial implant for knee replacement
Exactech announced today that it received FDA 510(k) clearance for its Truliant porous tibial tray, a 3D tibial knee implant. Truliant leverages additive manufacturing to create a porous structure designed to mimic the structure of cancellous bone. Exactech designed it to facilitate both initial and biological fixation to accommodate patients’ active lifestyles. The laser-printed 3D […]
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
iRhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and labeling updates. San Francisco-based iRhythm submitted two updates to the mobile cardiac telemetry device following an FDA warning letter last year. The letter, made public shortly after the company’s announcement, accused iRhythm of violations related to rules for labeling, quality […]
Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system. San Jose, California-based Vantis develops the CrossFast system along with the CrossShock intravascular lithotripsy (IVL) system. It designed CrossFast to help physicians perform faster, easier and safer procedures. The guide extension catheter offers additional support and facilitates […]
Boston Scientific wins FDA nods for nav-enabled Farapulse catheter, software
Boston Scientific announced today that it received FDA approval for its navigation-enabled Farawave Nav ablation catheter and clearance for new Faraview software. The two technologies comprise part of the company’s Farapulse pulsed field ablation (PFA) system. Boston Scientific initially won FDA approval for Farapulse in January. In doing so, it became second company to earn […]
Momentis Surgical wins FDA clearance for its surgical robot
Momentis Surgical (formerly Memic) announced today that it received FDA 510(k) clearance for its Anovo robotic surgical platform. Anovo received clearance for use in single-site, abdominal access across ventral hernia repair. The clearance complements Anovo’s existing approvals for natural orifice laparoscopic-assisted transvaginal benign gynecology procedures. Momentis designed Anovo as a single-port robotics platform and clearance […]
