Approvals

ConforMIS Hip Replacement System Gets 510(k) Clearance

The FDA has granted 510(k) clearance to ConforMIS’ iTotal Hip Replacement System.

The devices use single-use 3D-printed instruments in combination with the company’s patient-specific technology.

The system uses the personalization technology to design customized knee implants, cutting out risks associated with hip replacements such as dislocation, uneven leg lengths and limited reproducibility. Because the replacement hips offer a better match for the patient’s anatomy, the system can address these shortcomings and improve patient outcomes, said Scott Ball, M.D., of the University of California, San Diego’s Department of Orthopedic Surgery, a member of the device’s design team.

FDA Clears Custom Ultrasonics to Resume Manufacturing Endoscope Reprocessor

The FDA cleared devicemaker Custom Ultrasonics to resume manufacture of its System 83 endoscope washer-disinfector.

The agency had previously required the company to perform validation testing for the device’s water filtration system and its inline disc filter. The filters underwent testing by independent laboratories with no change in design, and the agency then accepted the performance data, the company said.

The FDA has reinstated the use of the components in flexible endoscopes that are not duodenoscopes. The company is currently working with the FDA to validate the system for duodenoscopes, and it strongly recommends against reprocessing those until further notice.

LiveNova’s Epilepsy Device Gets Expanded Approval for Use With MRIs

The FDA granted an expanded approval for LiveNova’s AspireHC and AspireSR vagus nerve stimulation devices to allow use in combination with MRIs.

The devices prevent or shorten seizures in patients with drug-resistant epilepsy by sending mild pulses to the vagus nerve.

Previously, the device could only be used with special MRI equipment. Under the expanded access, the AspireHC and AspireSR models can now be used with any MRI.

Royal Philips Gets FDA Clearance for Latest Radiology Platform

Royal Philips announced FDA marketing clearance for its IntelliSpace Portal 9.0 radiology platform.

The platform uses multimodal applications that allow radiologists to visualize and quantify extremely subtle symptoms and differences over time, according to Mark van Buchem, professor of neuroradiology at the Leiden University Medical Center, one of the platform’s development partners.

The platform has been available outside of the United States since last November and is set to hit the U.S. market by the end of June. The newest version will feature additional applications for longitudinal brain imaging, multi-modality tumor tracking and optimized lung nodule assessment.