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More federal regulators are knocking on Theranos’ door, keen on getting answers to questions about staff qualifications and improper review of patient test results. Read More
Aiming to improve the safety of medical device connections in clinical settings, ISO has published a new standard on neuraxial applications for small bore-connectors. Read More
Explosion fears have prompted the FDA to warn facilities and consumers not to use one of OxySure Therapeutic’s portable emergency oxygen systems. Read More
Stakeholders are encouraging the FDA to beef up its stance on cybersecurity, making suggestions provided in draft guidance mandatory rather than voluntary. Read More
The FDA has slammed Advanced Vision Science for potentially distributing intraocular lenses in the U.S. that were rejected for the Japanese market. Read More
The FDA has labeled the recall of Cook Medical’s single lumen central venous catheters and pressure monitoring sets and trays as Class 1, meaning it could cause serious injury or death. Read More
Companies that develop laboratory-developed tests should begin to incorporate design controls and establish a quality system ahead of the expected finalization of FDA guidance this year, experts advise. Read More