The agenda for the U.S. FDA’s Sept. 8-9 advisory hearing includes a proposed down-classification of bone growth stimulator (BGS) devices to class II, but while the proposal met some resistance from an industry group, the panel sided with the FDA and declared BGS units ready for prime time as 510(k) devices.
Keeping you up to date on recent developments in orthopedics, including: Implant choice more important than surgeon skill for hip replacement success; Vertebral body tethering shows clinical success as treatment for scoliosis; Hip fracture risk linked to nanoscale bone inflexibility; Bioventus reports first use of its Signfuse bioactive bone graft in strip format.
Keeping you up to date on recent developments in orthopedics, including: Hip fracture risk linked to nanoscale bone inflexibility; High intensity physical activity in early life could lead to stronger bones in adulthood; Xtant Medical reports U.S. launch of the Matriform Si; Opioid prescription rates for knee surgery vary, but higher strength dosage common.
Medtronic plc reported first-quarter worldwide revenue of just over $6.5 billion, a decrease of 13% as reported. As Cowen’s Josh Jennings wrote, the company’s results were better than expected, with an organic revenue growth decline of 17% vs. the Street’s prediction of a 25% decrease.
Keeping you up to date on recent developments in orthopedics, including: Simultaneous stimulation helped a spinal cord injury patient regain the ability to walk; Researchers identify better classification system for adult idiopathic scoliosis; Mixing silk with polymers could lead to better biomedical implants.
Keeping you up to date on recent developments in orthopedics, including: Long-term risks of joint implants; New approach to treating osteoarthritis advances; Osmotic therapy device reduces swelling to prevent secondary injuries in rats.
Keeping you up to date on recent developments in orthopedics, including: Implanted neural stem cell grafts show functionality in spinal cord injuries; Silk scaffolds and magnetism to generate bone tissue and be able to use it in implants; Hydrogel paves way for biomedical breakthrough; New strategy against osteoporosis.
Orthopedic companies felt pressure from COVID-19 in their most recent quarters. For example, Zimmer Biomet Holdings Inc. reported second-quarter net sales of $1.226 billion, a decrease of 38.3% from the prior-year period. Still, those revenues did come ahead of expectations, as Wells Fargo analyst Larry Biegelsen noted – $432 million ahead of his group's estimate and $305 million ahead of consensus.
A bioelectronic platform that stimulates the vagus nerve to reduce inflammatory activity and restore balance in the immune system is the ultimate aim of Setpoint Medical Inc. The Valencia, Calif.-based startup is preparing to start a U.S. pivotal trial for its most advanced program in rheumatoid arthritis (RA) later this year or early next.
Keeping you up to date on recent developments in orthopedics, including: Lego-inspired bone and soft tissue repair with tiny, 3D-printed bricks; Mutant zebrafish reveals a turning point in spine's evolution; Newly discovered cells act as a warning signal for rheumatoid arthritis flares.
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