Cymedica Orthopedics Inc. received FDA clearance for its Intellihab system to reduce pain associated with osteoarthritis in the knee. The system uses neuromuscular electrical stimulation to strengthen muscles supporting the knee without requiring typical exercises such as squats that could increase pain and further degrade the joint. Intellihab includes a knee brace that emits the pulses and a smartphone app patients use to track and manage the therapy.
Imagine an orthopedic implant that not only accelerates bone healing but also captures data to support real-time clinical decisionmaking. That’s the vision of Intelligent Implants Ltd., whose Smartfuse system recently won FDA breakthrough device designation. The first indication is for lumbar spinal fusions.
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.
TORONTO – Arthrolense Inc. has just seen its bank balance swell after Lynx Equity Ltd. invested $2 million to further develop the startup’s augmented, mixed reality surgical guidance systems for hip and knee replacement. According to orthopedic surgeon and company CEO David Backstein the Arthrolense system uses vastly improved hologram-based technologies to solve problems that persist in computer navigation and robotic systems.
TORONTO – Startup company Stoko Inc. has raised C$6 million (US$4.74 million) in seed funding to accelerate market expansion of a device it said will give rigid knee braces a run for their money.
My01 Inc. has received FDA clearance for its My01 Continuous Compartmental Pressure Monitor with full Bluetooth capabilities. The device is intended to help doctors diagnose and avert the risks of developing compartment syndrome, a potentially devastating complication of certain fractures and trauma injuries.
Keeping you up to date on recent developments in orthopedics, including: Skin and bones repaired by bioprinting during surgery; Researchers use AI to detect wrist fractures; Smart Score quantifies clinical outcomes for shoulder arthroplasty patients.
Keeping you up to date on recent developments in orthopedics, including: 3D biomaterial used as 'sponge' for stem cell therapy to reverse arthritis; New biomaterial regrows blood vessels and bone, RCSI research; Without major changes, gender parity in orthopedic surgery will take two centuries.
Zimmer Biomet Holdings Inc. has won the FDA’s nod for its Rosa Partial Knee system for robotically assisted partial knee arthroscopy. The new system is the latest addition to the Rosa Robotics platform, which also includes the Rosa Knee system for total knee replacement and Rosa One for neurosurgical and spine procedures. The Rosa Partial Knee system is designed to be compatible with Zimmer’s Personal partial knee. It incorporates 2D to 3D X-Atlas imaging technology and real-time, intraoperative data collection on both soft tissue and bone anatomies to ensure accurate bone cuts and improve range of motion gap analysis.
Agnovos Healthcare LLC, a company using regenerative medicine to treat localized effects of bone disease, has received the FDA’s nod for an IDE clinical trial to assess its AGN1 local osteo-enhancement procedure (LOEP) small-volume (SV) kit in patients with vertebral compression fractures (VCFs). The investigational device is intended to treat stable but painful VCFs via a minimally invasive procedure. The kit, which comes in the form of two single-use trays, contains a calcium-based, resorbable, triphasic implant material that is designed to align the pace of resorption with bone formation, providing treated vertebrae with immediate and durable protection.
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