The term of follow-up in clinical studies is the subject of massive speculation at FDA advisory hearings, but a recent FDA workshop suggests the agency may adjust its expectations, depending on the device. Darrell Brodke, of the University of Utah, said on a recent spinal device workshop that the two-year endpoint in some spinal device studies struck him as somewhat arbitrary, adding that a longer duration of follow-up is necessary to capture some device failures, but that two years is perhaps overly long where some other outcomes measures are concerned.

Orthopedics device startup Amber Implants BV has received an FDA breakthrough designation for its cementless spinal implant Vcfix. The system is designed to treat vertebral compression fractures (VCFs), which can cause patients severe back pain and limited mobility. Currently, VCFs are treated with injection of bone cement into the vertebra.

TORONTO – Numalogics Inc. has entered a partnership deal with Sawbones Inc. to develop computational modeling and simulation software for small and medium sized orthopedic manufacturers. Adding Montreal-based Numalogics’ computational simulation software to Seattle-based Sawbones’ biomechanical test line is intended to help customers optimize their orthopedic device designs more quickly and efficiently. The software is expected to be market ready in 2022.

Australia’s TGA provided updates regarding up-classification of several device types, including a number of spinal implants, which will henceforth be regulated as high-risk, class III devices, rather than medium-to-high risk devices (class IIb).

Medtronic plc strengthened its suite of products for minimally invasive spine surgery with several new additions. The portfolio provides an integrated solution that includes implants, navigation, robotics, and artificial intelligence to streamline transforaminal lumbar interbody fusion (TLIF), customize treatment for patients and improve outcomes.

Locate Bio Ltd. has closed a £10 million (US$13.8 million) funding round co-led by investors Mercia Asset Management and BGF to advance its orthobiologics product pipeline. The Nottingham, U.K.-based startup, which spun out from the University of Nottingham’s School of Pharmacy, is hoping to disrupt the orthobiologics market with its drug releasing, bone grafting products.

Onkos Surgical Inc. nabbed an additional $15 million from its existing investors in a series C fundraising round. The Parsippany, N.J.-based company plans to use the new cash to accelerate research and development for its product line which is designed to meet the specialized needs of oncology patients who require orthopedic surgery and the surgeons who work with them.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia against Medtronic Australasia Pty Ltd. for alleged unlawful supply of its Infuse bone graft kit, which contains a medicine and other components to stimulate bone growth in patients.

Digital health has made only limited headway in the orthopedics space, but Zimmer Biome Inc. and Canary Medical Inc. have nudged the cause along with a smart implant that blends a 21st century sensor with a traditional knee replacement device. The marriage of Zimmer’s Persona knee implant and the Canary Medical Canturio TE sensor will give physicians a better way to track the patient’s recovery from knee replacement procedures.

Auctus Surgical Inc. took another step toward straightening out one of the most vexing problems in pediatric scoliosis with the announcement of FDA breakthrough device designation for its vertebral tethering system. The system offers a non-surgical option to correct spinal curvature without use of fusion or braces and its dynamic magnetic technology enables adjustment as a child grows, avoiding the overcorrection that plagues the only other tethering system currently available.