Canon Medical Systems announced today it received FDA 510(k) clearance for expanded capabilities with its Deep Learning Spectral CT. Tustin, Calif.-based Canon’s Deep Learning Spectral CT’s expanded capabilities reach into cardiovascular applications now, according to a news release. The CT is available on Canon’s Aquilion ONE/Prism Edition CT system, offering healthcare providers the ability to […]
510(k)
Crown Aesthetics wins FDA clearance for wrinkle treatment device
Crown Aesthetics this week said it received FDA clearance for its SkinPen Precision device for treating wrinkles on the neck. The SkinPen Precision microneedling technology is safe for use with a depth of up to 2.5mm on the neck, according to the company. It is intended to be used as a treatment to improve the […]
FDA clears Activ Surgical hardware for enhanced surgical visualization
Activ Surgical announced today that it’s won FDA 510(k) clearance for ActivSight, the company’s intraoperative imaging module for enhanced surgical visualization. Todd Usen, the Boston-based company’s CEO, described the clearance as “big news” in a LinkedIn post. “This clearance gets us one step closer to bringing our technology to ORs around the world and enabling […]
FDA clears Philips’ Smart CT application software
Royal Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its Philips SmartCT application software. Amsterdam-based Philips’ SmartCT software is a component of the company’s Azurion image-guided therapy system for diagnosis, therapy planning, treatment and follow-up for interventional radiology procedures. SmartCT helps to enhance clinical confidence, smooth the workflow and increase productivity through […]
Medtronic can’t shake suit over FDA clearance of spinal devices
A federal appeals court has ruled that Medtronic must face a whistleblower lawsuit over FDA clearance of certain spinal fusion devices. The Dan Abrams Company sued Medtronic in 2015 claiming that Medtronic defrauded the FDA into granting 510(k) clearance to certain Verte-Stack cervical vertebral body replacement (VBR) devices used in spinal fusion surgeries. The lawsuit […]
FDA clears Orthofix 3D-printed titanium cervical spacer system
Orthofix Medical (NSDQ:OFIX) announced today that it received FDA 510(k) clearance for its Construx Mini Ti spacer system. Lewisville, Texas–based Orthofix also administered the first patient implant of the 3D-printed Construx Mini Ti system, which is designed to enhance anterior cervical discectomy and fusion (ACDF) procedures, according to a news release. The Construx Mini Ti […]
GE Healthcare 2D/3D imaging system wins FDA nod
GE Healthcare has announced FDA 510(k) clearance for a new surgical imaging system capable of 3D and 2D imaging. OEC 3D offers interoperative 3D imaging with precise volumetric images for spine and orthopedic procedures, according to GE Healthcare. It combines the benefits and familiarity of 2D imaging with OEC C-arms, delivering a familiar user experience with […]
Companies, docs alarmed by proposed 510(k) rollback
Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process. HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, […]
FDA clears Catalyst OrthoScience reverse shoulder system
Catalyst OrthoScience today announced that it received FDA 510(k) clearance for its reverse shoulder system. The reverse shoulder system is a total shoulder prosthesis designed for severe shoulder arthritis patients in conjunction with a grossly deficient or non-functional rotator cuff. The design is inverted compared to traditional anatomic total shoulder prosthesis where the articulating sphere […]
Qardio lands 510(k) for ambulatory ECG device
Qardio this week announced that it received FDA 510(k) clearance for its QardioCore ambulatory ECG device. QardioCore is an extension of Qardio’s remote patient monitoring platform for primary care and hypertension monitoring to acute care and cardiology. The device requires no special skin preparation, gels, adhesives or patches. It can be easily self-fit, removed and […]
ControlRad gains clearance for imaging tech to sell to Boston Sci
ControlRad announced today that it received FDA 510(k) clearance to market its ControlRad Select radiation reduction technology. Atlanta-based ControlRad’s technology uses proprietary semi-transparent filters with a user-interface tablet and imaging processing algorithms that are retrofitted onto customers’ existing Siemens Artis zee interventional imaging systems, according to a news release. ControlRad, ahead of its commercialization efforts […]
