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The FDA has extended its delay on conducting in-person domestic surveillance in-spections through Feb. 4 with the goal of restarting the activities as soon as safely pos-sible. Read More
In responses to two Republican senators, Robert Califf — the Biden administration’s nominee for FDA commissioner — provided a deeper look into the priorities he would set at the helm of the agency if confirmed to the top post once again. Read More
SoftSmile is currently working with several aligner manufacturers, but will now start marketing Vision as a standalone application to be used directly by doctors. Read More
If the chemical breakdown occurs, it may cause serious harm to patients, including irritation of the respiratory tract and lung swelling caused by excess fluid, the FDA said. Read More
The system combines AI-based image guidance with anatomy recognition to create a patient-specific plan that is presented to the surgeon using the augmented reality display. Read More
New Britain, Pa.-based Thrombolex said its endovascular-thrombolytic delivery system cleared 90 percent of totally occluded pulmonary arteries in an interim analysis from a pivotal trial. Read More
In its continuing effort to hire highly skilled senior executives from the private sector, the FDA took advantage of provisions in the 21st Century Cures Act to offer higher salaries than it could under traditional federal hiring authorities, but it still needs an overall workforce strategy for drugs and devices, the Government Accountability Office (GAO) said in a new report. Read More
The FDA expedites regulatory reviews of breakthrough devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Read More