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The FDA’s Medical Devices Advisory Committee recommended in a March 23 meeting that patients have their vision evaluated before periocular treatment with dermal fillers. Read More
Australia’s Therapeutic Goods Administration (TGA) has outlined its expectations for developers of in vitro diagnostic (IVD) self-tests for infectious diseases like influenza, hepatitis B and hepatitis C, chlamydia, gonorrhea and syphilis. Read More
The FDA said it is investigating numerous medical device reports (MDRs) of patient infections and contamination associated with reprocessed urological endoscopes, including three reported deaths outside the United States. Read More
The acquisition, which is comprised of a $714 million cash payment and $81 million in net debt, is expected to close early in the fourth quarter. Read More
The microneedle works by creating controlled micro-injuries that spur the body’s natural wound-healing process while minimizing cellular damage. Read More
The clip-based therapy is a nonsurgical heart valve repair option that enables physicians to customize valve repairs based on the patient’s unique anatomy. Read More
The company said it redesigned the system by reshaping the mesh strip and relocating its initiator chemical, addressing common complaints in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Read More
“Patients who receive the XIENCE stent with shorter dual anti-platelet therapy durations do not have an increase in cardiac events and showed a reduction in severe bleeding, proving short dual anti-platelet therapy strategies with the XIENCE stent are safe in high bleeding-risk patients,” Abbott said. Read More