May 24, 2019

Vol. 16 No. 100

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Editor’s Note

In observance of the Memorial Day holiday, FDAnews Device Daily Bulletin will not be published Monday, May 27. The next issue will be published Tuesday, May 28. Read More

FDA Broadens Clearance of Roche’s STD Diagnostic Test

The test can use various sample types to detect the two STDs, including urine samples, vaginal swabs and endocervical swabs. Read More

Reflexion Health’s Digital Physical Therapy System Grabs FDA OK

The system keeps track of a patient’s physical therapy progress and statistics via a dashboard. Read More

FDA Finds Quality Lapses at Las Vegas Defibrillator Manufacturer

FDA investigators found that the firm’s battery testing and calibration equipment was not validated. Read More

Royal Philips Snags Additional 510(k) Clearance for Radiotherapy Simulator

The simulator gathers both soft tissue and density maps from a single MR exam. Read More