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To meet a requirement of the 21st Century Cures Act, the FDA is seeking comments for a report on the patient safety and best practices impact of nondevice software functions. Read More
Precision Nuclear of Virginia landed a Form 483 following a March 22 to 25 inspection of its Roanoke, Va., facility where FDA officials observed multiple quality lapses. Read More
The FDA’s review of proposed instructions for use (IFU) for a new drug, biologic or combination product will focus on accuracy and consistency with the agency-approved prescribing information, according to a final labeling guidance issued yesterday. Read More
Combining murmur analysis AI with digital stethoscopes transforms the traditional stethoscope into a low-cost screening tool, the company said. Read More
With an option for future acquisition of CathWorks, Medtronic has announced that it will invest $75 million and immediately begin co-promotion of CathWorks’ FFRangio System in the U.S., Europe and Japan. Read More