News and Notes

Advanced Sterilization Products (ASP) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a 15-minute time to result on the STERRAD VELOCITY® Biological Indicator (BI)/Process Challenge Device (PCD) for use in STERRAD...

The U.S. Food and Drug Administration (FDA) has announced a public meeting entitled: Communications About the Safety of Medical Devices, which will be held on April 1, 2020. During this meeting, we will: Share the FDA’s current practices about medical device safety...

Checkpoint Surgical has announced that it will add 18 new jobs at its headquarters in Highland Hills, Ohio, with the assistance of an Ohio Job Creation Tax Credit totaling $200,000. The addition of these 18 jobs comes with an associated payroll of $1.9 million;...

Amolea AT2 and the AsahiKlin AE-3000 series of environmentally sensible fluorinated solvents from AGC Chemicals provide medical device manufacturers a safer, highly effective and environmentally friendly alternative to other solvents such as n-propyl bromide and...

In a letter to customers, Cardinal Health issued an “Urgent Medical Device Recall” for some of its surgical gowns. “The purpose of this letter is to advise you that Cardinal Health is voluntarily recalling specific production lots of single-sterile and bulk...

Mindray Medical has announced the release of a new point-of-care ultrasound system. The TE7 ACE is a new touch screen ultrasound system that provides targeted solutions to diverse point-of-care scenarios including: anesthesia, critical care and emergency. Featuring...