LONDON – Sirakoss Ltd. has received FDA 510(k) clearance for its nanoparticle synthetic bone graft substitute, after showing the ready-to-use putty is equivalent to the CE-approved dry formulation. Rather than granules that are mixed with a patient’s blood before administration, the inorganic calcium phosphate-based Osteo3 Zp putty consists of the granules suspended in a fully synthetic resorbable carrier.
Keeping you up to date on recent developments in orthopedics, including: Osteoporosis treatment also may protect against pneumonia; Study finds similar short-term outcomes after common MI spine procedures; New biomaterial has potential to repair damaged bone with lower risk of inflammation; Diabetics face greater risk of bone fractures.
The U.S. FDA granted Gtx Medical BV a breakthrough device designation for its implantable Go-2 Targeted Epidural Spinal Stimulation (TESS) system. The device enabled patients who had sustained traumatic spinal cord injuries to regain voluntary control over previously paralyzed muscles and walk again four or more years after paralysis, according to a study previously published in Nature.
Keeping you up to date on recent developments in orthopedics, including: Researchers restore injured man's sense of touch using brain-computer interface technology; Down to the bone: Understanding how bone-dissolving cells are generated; Improved MRI scans could aid in development of arthritis treatments.
Keeping you up to date on recent developments in orthopedics, including: IMPACT study shows 25% reduction in health care costs associated with earlier prosthetic care; Human growth hormone treatment after ACL injury may prevent loss of muscle strength; Osteoporosis treatment may also protect against pneumonia.
Lowell, Mass.-based startup Launchpad Medical LLC has picked up an additional $1.8 million grant from the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center to advance the development of its bone graft solution. The company plans to use the funds to conduct a pivotal animal study of the injectable biomaterial, which will pave the way for a U.S. FDA-approved clinical trial.
Keeping you up to date on recent developments in orthopedics, including: Cell 'pores' discovery gives hope to millions of brain and spinal cord injury patients; Little skates could hold the key to cartilage therapy in humans; Spinal cord injury increases risk for mental health disorders.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. has submitted a 510(k) application to the U.S. FDA for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The submission follows positive results from an FDA-guided bone regeneration study, which is a key component toward the goal of gaining U.S. marketing approval.
Keeping you up to date on recent developments in orthopedics, including: Lab engineers 3D-functional bone tissues; Comparison of early postoperative pain after first vs. second total knee arthroplasty; Vitamin B3 revitalizes energy metabolism in muscle disease; Worldwide IOF-ISCD survey of bone densitometry units published.
Keeping you up to date on recent developments in orthopedics, including: UCLA scientists create first roadmap of human skeletal muscle development; Excess coffee consumption a culprit for poor health; Arthritis clinical trial shows support for dextrose injection to alleviate knee pain; Gene therapy in mice builds muscle, reduces fat.
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