The company has provided two products since 2002. Read More

Two major manufacturers of duodenoscopes marketed in Australia have initiated recalls to address contamination after reprocessing. Read More

This cartridge is designed to mimic the function of the digestive enzyme lipase. Read More

Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis. Read More

Monteris Medical initiated a nationwide recall of its SideFire Select 2.2 mm Directional Laser Probe, following reports of fracture that resulted in CO2 introduction in the brain. Read More

In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics. Read More

The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test. Read More

Patients already implanted with the product should be followed as usual. Read More

The systems are intended for gynecologic laparoscopies. Read More

Health Canada has finalized its regulations on in vitro diagnostic labeling 18 years after issuing draft guidance. Read More

The FDA is investigating the risk of serious burns and potential permanent scarring with the use of Teva’s iontophoretic transdermal patch Zecuity to treat acute migraine headaches. Read More