Life Spine To Pay Almost $6M In Kickback Settlement
The spinal implant company and two executives have agreed to pay almost $6m to resolve a health-care fraud case. Life Spine Inc. reportedly paid out almost $7m in illicit consulting and licensing fees between 2012 and 2018.
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The US agency is warning manufacturers about an alarming device submission trend toward unreliable data generated by third-party labs.
News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.
A year after Congress officially gave the FDA the power to ban devices for a specific use, the school that inspired the new law is taking the agency back to court on allegations it has failed to respond to document requests.