US FDA Announces Trial-Focused Spinal Devices Workshop
Executive Summary
The 17 September session will home in on the details of spinal device regulation, including adverse event reporting and efforts to increase diversity in study populations.
You may also be interested in...
Medtronic Recalls Cardiac Defibrillators Due To Reduced Shock Potential
The device giant is recalling Cobalt and Crome defibrillators because they may deliver weaker shocks than intended.
US FDA Waits Until December To Enforce Unique Device Identifier Database For Low-Risk Devices
Agency won’t require manufacturers to submit class I devices to the database for an extra 75 days, and doesn't plan to enforce GUDID regulations against consumer health products.
Surgalign Pays $2M To Resolve SEC Investigation
US financial regulators said that the spinal device company falsely attributed future sales to the current quarter as a way to disguise lower-than-expected sales.