May 20, 2019

Vol. 16 No. 96

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DiaSorin Molecular’s Herpes Assay Grabs CE Mark

The assay produces results in about an hour and involves minimal hands-on interaction. Read More

Flat Medical’s Epidural Protector Cleared by FDA

The syringe alerts anesthesiologists to the moment it has arrived at the epidural space, avoiding the risk of accidental puncture. Read More

FDA Greenlights Masimo’s Tetherless Pulse Oximetry Monitor

The monitor allows patients to move freely for easy transitions between care areas. Read More

North Carolina Devicemaker Cited Over Design Controls

“The firm's missing design plans were necessary to ensure that the supporting device test records submitted with the 510(k) were complete and accurate,” the FDA said. Read More