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The FDA noted that Acella has received 43 reports of serious adverse events to date that may be linked to the substandard underactive thyroid drugs. 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 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 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 experimental gene therapy has also secured Fast-Track, Orphan Drug, Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations from the FDA. 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