Zimmer Biomet Holdings Inc.’s Rosa robotics surgical assistant snapped up its fourth application with the U.S. FDA’s 510(k) clearance for use in shoulder replacement surgery. Over the past five years, the system has built a portfolio that includes partial and total knee replacement and total hip replacement.
Wandercraft SAS broadened its U.S. FDA clearance for the Atalante X to include rehabilitation in individuals with spinal cord injuries at levels T5 to L5. The self-balancing exoskeleton was already given the greenlight by the FDA for use in stroke rehabilitation in December 2022. “We are thrilled to have two FDA clearances, first for stroke and now spinal cord injury, in less than a year,” CEO Matthieu Masselin, told BioWorld.
It’s been a good month for Illuminoss Medical Inc. In less than three weeks, the East Providence, R.I.-based company received U.S. FDA clearance of its new light-emitting diode (LED) console, achieved the 10,000th use of its bone-strengthening technology and presented promising results of research on use of its signature blue light for antimicrobial applications.
A team of inventors from Artarmon, Australia-headquartered Saluda Medical Pty Ltd. including founder and former CEO, John Parker, applied for patent protection for enhancements to the neurostimulation monitoring capabilities of Evoke.
A new wearable “hip-assist” robot developed by Samsung Electronics Co. Ltd. significantly improves gait, balance and dynamic movement in older adults and has the potential to not only enhance physical function but also mitigate the risk of falls.
In a boon to older women worldwide, Bone Health Technologies Inc. received U.S. FDA clearance for its Osteoboost device, which reduces loss of bone strength in postmenopausal women. It is the first device cleared for intervention to slow loss of bone density or osteopenia before it advances to osteoporosis.
Investors bailed on many med-tech companies last year, fearing that the frenzy surrounding GLP-1 agonists would tank companies in the weight-loss, diabetes and orthopedics segments. Their concerns now appear overblown in many instances, with some of the most directly affected businesses reporting a “rising tide” associated with an increased focus on obesity treatment that has lifted their boats rather than sinking them.
Researchers from three California-based institutions are seeking patent protection for systems, devices and methods that allow brain-controlled limb movement and sensation.
Renovos Biologics Ltd. was granted a U.S. FDA breakthrough device designation for its Renovite BMP-2 (bone morphogenetic protein-2) product, which is designed for interbody spinal fusion.
Asia continues its push to be the global leader with precision health and artificial intelligence/machine learning (AI/ML) models for diagnosing disease. Most health care systems in Asia’s major markets include universal health care coverage and are leaning toward electronic health records, paving the way for seamless use of data. At the same time, AI/ML is making its way across the entire health care spectrum, including applications to diagnose breast cancer, kidney disease, cognitive decline, depression and even retinal imaging to detect cardiac disease.