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Home » Topics » Disease categories and therapies » Orthopedics

Orthopedics
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Device makers back on US FDA’s warning letter radar screen

March 18, 2024
By Mark McCarty
The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
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U.S. FDA headquarters

Manufacturing change prompts removal of Cardinal’s Monoject

March 12, 2024
By Mark McCarty
The U.S. FDA announced March 7 that Cardinal Health of Dublin, Ohio, has expanded a product correction for Monoject devices to a product removal because of manufacturing changes that could affect product performance.
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Zimmer Biomet Rosa shoulder

Zimmer Biomet wins new FDA clearance of Rosa robotic shoulder system

Feb. 23, 2024
By Annette Boyle
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.
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Wandercraft Atalante-X Exoskeleton

Wandercraft gets second FDA nod for self-balancing exoskeleton

Feb. 16, 2024
By Shani Alexander
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.
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IlluminOss Medical ABL light fiber

Illuminoss blue-light special gains new clearance, shows antimicrobial efficacy

Feb. 12, 2024
By Annette Boyle
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.
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Saluda Evoke SCS
Patents

Saluda improves its Evoke SCS system for pain management

Feb. 1, 2024
By Simon Kerton
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.
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Samsung GEMS device

Wearable ‘hip-assist’ robots improve gait, balance in older adults

Jan. 23, 2024
By Tamra Sami
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.
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Osteoboost Belt

FDA clearance strengthens Osteoboost’s position as first osteopenia device

Jan. 19, 2024
By Annette Boyle
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.
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Coin stacks layered with charts

GLP-1 not all loss, sweet side emerges for med tech

Jan. 16, 2024
By Annette Boyle
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.
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brain bionic suit
Patents

Researchers develop bidirectional brain-computer interface for ‘bionic suit’

Jan. 4, 2024
By Simon Kerton
Researchers from three California-based institutions are seeking patent protection for systems, devices and methods that allow brain-controlled limb movement and sensation.
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