Life Spine has entered into a settlement agreement with the USA government that successfully resolves all of the government’s claims. As part of the agreement, it will pay $5.5 million to the US government which noted historical shortcomings in its compliance programme. A press release reports that the company has made significant progress formalising and strengthening its compliance programme, adding that this was a process that began before any discussions with the government.
Furthermore, according to the press release, the government’s complaint made no claims questioning the quality, safety, or effectiveness of Life Spine products. Life Spine chose to settle the matter in order to focus on the future: developing new products and devices to enable doctors to better treat their patients.
Life Spine is a Research & Development driven company. Part of this process relies on surgeons who advise the company, a required industry practice. In accordance with industry guidelines and practice, no payments are tied to usership of Life Spine products. This collaboration has led to Life Spine being awarded more than 170 patents for medical devices and procedures. Life Spine looks forward to continuing to put patient needs first through innovation and surgeon collaboration.
For more information and to see the facts as agreed to, click here