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The FDA hit Heany Industries, a manufacturer of industrial ceramics and thermally based coatings, with a Form 483 for inadequate validations and corrective and preventive action (CAPA) procedures after an inspection of its Scottsville, N.Y., facility in March. Read More
Endologix said it is preparing to submit its Detour percutaneous bypass system for the FDA’s premarket approval, following the successful outcome of a pivotal study. Read More
The blood test can detect a biomarker for NETosis, can predict disease severity and can monitor its progression and the response to treatment, the company said. Read More
Failure to treat all medical device complaints as complaints is among the leading pitfalls related to Medical Device Reporting (MDR), according to Pamela Forrest, a former FDA official who is now a partner in the law firm Covington & Burling. Read More
Insightec’s Exablate ultrasound cancer therapy is safe and effective against prostate cancer, according to the results of a multisite study reported in The Lancet Oncology. Read More
Angel Medical Systems, a device company that offers an implantable cardiac monitoring and alerting system, was hit with a Form 483 for corrective and preventive action (CAPA) and documentation lapses observed during a March inspection of its Eatontown, N.J., facility. Read More