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The company is currently conducting a randomized, multicenter pivotal study for the device. The study, which began in May 2020, will continue at up to 25 U.S. sites. Read More
The system features wireless capabilities, including a hospital connectivity tool, a mobile app for home use and a cloud-based web management platform for healthcare providers. Read More
A clinical trial in metastatic prostate cancer patients found that the software’s sensitivity was 92 percent for regional lymph nodes, 91 percent for distant lymph nodes and 87 percent for bone, the company said. Read More
The agency kicked off the Quality in 510(k) Review pilot in September 2018 with the goal of simplifying how devicemakers submit certain 510(k) notifications. Read More
The company, which is headquartered in Munich, Germany, has received FDA designation as an ASCA accredited laboratory, which authorizes it to perform premarket testing for device makers looking to enter the U.S. market. Read More
The platform consists of proprietary software using computer vision and artificial intelligence algorithms and connected smart glasses that are worn by the surgeon. Read More
The device delivers photoacoustic-generated, laser-induced optical breakdown to quickly fracture and fragment artificial and natural pigments in the skin. Read More
According to the company, the test offers performance comparable with reverse transcription polymerase chain reaction (RT-PCR) analyses that use nasopharyngeal swabs. Read More