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With less than one year before the EU’s Medical Device Regulation takes effect, an industry group is raising increasing alarm about the lack of “essential guidance” and the shortage of notified bodies needed to certify products in compliance with the new requirements. Read More
The deal nets Canady a robotic needle holder and a 5mm motorized articulated surgery device that enables access to intra-abdominal areas, among other items. Read More
Devicemakers that participate in the Medical Device Single Audit Program (MDSAP) should not have to undergo notified body certification, the committee says. Read More
Acting FDA Commissioner Ned Sharpless said that ACell placed profit above patient safety when it failed to notify the FDA about the product’s recall. Read More