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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
The company said its submission is meant to bring its regulatory clearance for the system up to date, implement updated features and address the issues it’s seen with recalls. Read More
The device does not directly contact blood flow, limiting the risk of thrombosis, stroke and infections that can occur from devices implanted inside the heart. Read More
Using automated software analysis and the company’s PlexPrep liquid handling system, 480 to 1,920 patient samples can be processed in an 8-hour shift, the company said. Read More