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BioVision Technologies, a Boulder, Colo.-based device company, has shut down in the wake of an FDA inspection that observed multiple failures in procedures, controls and documentation. Read More
In a new guidance on ethical issues, the Advanced Medical Technology Association (AdvaMed) advises against letting a device company’s sales department select as trainers if the company aims to implement bona fide training and education programs for healthcare professionals (HCPs). Read More
Medtronic has completed its $1.1 billion acquisition of the ear, nose and throat (ENT) implant manufacturer Intersect ENT, picking up Intersect’s Propel and Sinuva drug-eluting sinus implant product lines and its Menlo Park, Calif., facility. Read More
Manufacturers of legacy devices that were not designed with cybersecurity in mind must tell customers during the procurement process when they will stop providing cybersecurity support, the International Medical Device Regulators Forum (IMDRF) advises in a just-published draft document. Read More
The FDA was slow to begin phasing out its policy that allowed the emergency authorization of hundreds of COVID-19 tests before their efficacy was proven. Read More
Inadequate procedures for validations, design changes and complaints were spelled out in a five-observation Form 483 handed to Pemco, a cardiothoracic surgical devicemaker, after an inspection of its facility in Independence, Ohio last December. Read More
Kansas-based Telememory, doing business as MoodSpark, has acquired Dthera Sciences, gaining the San Diego, Calif. company’s cognitive behavioral therapy (CBT) technology for seniors suffering from confusion or memory loss. Read More
Patients whose feeding tubes were placed using Baltimore, Md.-based CoapTech’s PUMA-G bedside ultrasound imaging system had shorter hospital stays, according to researchers at the University of Maryland’s medical center. Read More