The U.S. FDA warning letter to Globus Medical Inc., highlights some long-running concerns at the agency about medical device reporting practices, but the agency was keen to point to a problem with the company’s complaint trending practices.
Zimmer Biomet Holdings Inc. reported it will buy Orthogrid Systems Inc., a company that makes artificial intelligence-driven surgical guidance systems for total hip replacement for an undisclosed amount, and expects to complete the deal by the end of the fourth quarter of 2024.
Royalties for licensed patents ordinarily need not be paid after the underlying patent has expired, but the case of Zimmer Biomet Holdings Inc. v. Insall would seem to throw out a cautionary flag regarding such agreements.
Loci Orthopaedics Ltd. raised €12.8 million ($14 million) in an oversubscribed series A funding round that will help bring its Indx implant system for thumb base joint arthritis to the market. “There is a major unmet clinical need in orthopedics extremities and thumb base joint arthritis is a highly and increasingly prevalent condition,” Brendan Boland, co-founder and executive chairperson of Loci, told BioWorld.
Inosys Korea Co. Ltd. gained U.S. FDA 510(k) clearance for Unispace, a cervical spine cage manufactured with 3D printing technology. Unispace can be used during spinal fusion surgery, Busan-based Inosys said, wherein operators can remove a patient’s diseased or damaged disc and replace it with the cervical cage to maintain the original length of the spine.
Amber Implants BV reported promising results from the first-in-human trial of patients fitted with its Vcfix spinal system which treats vertebral compression fractures. Data showed that patients experienced significant pain relief and regained the ability to walk without discomfort.
After Novosis Putty gained U.S. FDA breakthrough device designation of bio-fusion spine implantation device, South Korea’s Cgbio Co. Ltd. posted positive findings of similar ceramic bone graft, Novosis, to lay groundwork for U.S. market entry.
Crescom Co. Ltd., of Seongnam-si, Gyeonggi-do, gained domestic approval for its AI-powered software to grade knee osteoarthritis, dubbed MediAI-OA, while launching a new AI-mobile platform, Onzaram, to help manage child growth care.
As Johnson & Johnson's (J&J) first-quarter revenue missed Wall Street estimates for medical devices on April 16, CEO Joaquin Duato noted that the company will continue to look for major M&A plays to boost long-term growth in the wake of its recently reported $13.1 billion buy of Shockwave Medical Inc.
In what represents its first patenting, Pittsburgh-based Reach Neuro Inc. is seeking protection for methods, sensors, and systems for detecting movement of a spine and stimulating specific regions of the spinal cord in response to the movement.