Schwarzenegger Becomes Zimmer’s First Chief Movement Officer
Action star and former governor of California Arnold Schwarzenegger can add a new title to his resume: device-industry advocate.
Schwarzenegger will take on the newly created role of chief movement officer at Zimmer Biomet, the company announced on 13 November. In this role, he will work with Zimmer Biomet to “motivate, engage and support individuals to increase mobility, maintain joint health and proactively incorporate movement into their daily routines to foster overall health and wellness,” the company said in a press release.
The company explained that Schwarzenegger’s focus on innovation and lifelong fitness make him a natural match for Zimmer Biomet’s priorities.
“People are seeking to lead healthier, more active lifestyles as they age, and the demand for people to keep moving pain-free is increasing. Innovative solutions like ours are making it easier to achieve that goal,” explained Zimmer Biomet president and CEO Ivan Tornos. “I cannot think of a better partner than Arnold to join us as chief movement officer to help advance our shared mission to alleviate pain and improve the quality of life for people around the world.”
Schwarzenegger added, “I am energized by Zimmer Biomet’s Mission because it aligns with my own 50-year fitness crusade. I want every single person in the world to discover the joy of fitness and movement that has made my life better every step of the way. Through this partnership with Zimmer Biomet, I can continue to encourage others to make positive changes each and every day that support them living their best and most active lives possible.”
J&J MedTech Prepares Clinical Sites For Ottava Robotic System
Johnson & Johnson said 12 November the US Food and Drug Administration greenlighted its Ottava robotic surgical system investigational device exemption (IDE), which allows it to start clinical trials.
The company said it will prepare clinical sites to receive the Ottava systems, enroll patients and begin surgical cases, but did not reveal further details about the clinical study. J&J’s Ottava robotic system incorporates four robotic arms into a standard size surgical table, which allows the robotic arms to be stowed under the surgical table when they aren’t needed. This adaptable design will give surgeons more space to improve workflow, increase safety and enable a 360-degree patient access, said Eduardo Parra-Davila, a colorectal and general surgeon at the Palm Beach Digital Institute in a company statement last November when J&J MedTech first announced it submitted the robotic surgical system for an IDE.
“We are excited about reaching this important milestone and progressing our differentiated general surgery robotic platform for the benefit of patients and surgeons,” said Rocco De Bernardis, president, Ottava, J&J MedTech. “With approval to move to clinical investigation, our teams are focused on training clinical trial investigators and teams as they enroll patients and prepare for cases.”
The bed-side soft-tissue system will compete against Intuitive Surgical’s da Vinci surgical robot. The global robotics industry is expected to grow at a compound annual growth rate of 29% and reach $586bn by 2030, according to analysis by Global Data. The surgical robotics market is estimated to reach $10bn by year-end.
Dassault Systèmes Develops First Guide On Virtual Twins In Medtech Development
French software firm Dassault Systèmes has worked with the US FDA to develop the world’s first guide for the medical device industry on the use of virtual twins to accelerate clinical trials, the company announced recently.
The 44-page ENRICHMENT Playbook discusses how manufacturers can use a hierarchical framework and a strategic approach to challenges to conduct reliable virtual clinical trials, the company said. Virtual twins allow developers to accurately simulate patient populations through computer models, allowing researchers to reduce the use of human and animal testing.
Dassault and leaders from the FDA’s Office of Science and Engineering Laboratories, as well as stakeholders from academia and industry, collaborated on the ENRICHMENT project for five years. The final playbook incorporates recommendations drawn from the FDA’s final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.
“As the health care industry continues to embrace digital transformation, the ENRICHMENT Playbook represents a pivotal moment in the evolution of clinical trial methodologies,” said Claire Biot, vice president, life sciences and health care industry, Dassault Systèmes. “The strong participation and input from diverse experts was crucial in ensuring that the playbook meets the highest scientific and regulatory standards and is highly practical for immediate application in the field. We remain committed to driving collaborative innovation in this sector to improve the patient experience.”
GE HealthCare Wins FDA Clearance For Signa Magnus MRI Scanner
GE HealthCare announced on 13 November it received FDA 510(k) clearance for its Signa Magnus 3.0 T magnetic resonance imaging (MRI) system specifically designed for neuroimaging.
“With Signa Magnus, we are providing neuroradiologists and neuroscience researchers a tool that supports advanced imaging and biomarker research and discovery previously impossible on conventional systems,” said Jason Polzin, general manager, MR applications platform and research technologies at GE HealthCare.
Four investigational Magnus systems have been installed at Walter Reed National Military Medical Center, University of Iowa, University of Wisconsin and Madison and Brigham and Women’s Hospital, GE HealthCare said.
“FDA clearance is important because there’s a broad need for new biomarkers to study neurodegenerative disorders, and there’s an opportunity to better understand what’s happening in psychiatric disorders,” said Vince Magnotta, director of the MR Research Facility at the University of Iowa.
The system allows for faster imaging, which is particularly beneficial for patients who have difficulty remaining still, the company said.
Eko Health’s Digital Heart Platform Closer To Coverage
Medicare beneficiaries might soon have access to an advanced digital health tool that can detect heart disease during routine physicals.
Eko Health recently announced its SENSORA platform, which the FDA cleared in April, has received a category III procedural terminology, or CPT, code from the American Medical Association, which goes into effect in July 2025, putting the platform on the road to coverage and reimbursement.
In conjunction with a digital stethoscope, the SENSORA platform incorporates AI-infused algorithms to detect heart anomalies during standard checkups.
Eko Health’s Low Ejection Fraction (EF) AI, developed with the Mayo Clinic, allows physicians using the Eko digital stethoscope to detect Low EF, a key indicator for heart failure, in at-risk patients within 15 seconds.
The FDA-cleared algorithms can also identify other structural issues, such as heart murmurs and arrhythmias, including AFib.
Eko Health says receiving the code reflects SENSORA’s growing role as an “essential tool” in cardiac care, which the company expects to expand across multiple clinical environments.
Weill Cornell Receives Grant To Fight Alzheimer’s
Researchers at Weill Cornell Medicine have received a big boost in their efforts to combat Alzheimer’s disease. The National Institute on Aging, which is part of the National Institutes of Health, has awarded the medical school with a five-year, $6.2m grant to build a portable, high-resolution positron emission tomography, or PET, scanner that can detect the disease in its earliest stages.
The school said the scanner will stand upright, which is different from current scanners, to allow patients to sit during scanning.
Amir Goldan, an associate professor of electrical engineering in radiology at the university, said the scanner’s construction will enable researchers to move it to various medical centers that do not have brain imaging technology, which means expanded access and bringing “the highest-level of care to more diverse populations.”
Current scanners, according to Goldan, have poor spatial resolution that limits image quality and cannot provide reliable quantitative information on biomarkers, such as amyloid plaques and tau tangles, which are protein clumps found in the brains of those with Alzheimer’s.
The Weill Cornell scanner, however, called the Prism-PET, will detect “hot spots” — areas of increased concentrations of radioactive tracers — to enhance early detection.
“The earlier you can diagnose Alzheimer’s disease, the better the chances of therapy being effective,” Goldan said.
Mainz Biomed And Thermo Fisher Team Up Against Colorectal Cancer
Molecular genetics diagnostic company Mainz Biomed and life sciences company Thermo Fisher have joined forces to fight colorectal cancer.
The joint effort seeks to develop and potentially commercialize Mainz Biomed’s next generation colorectal cancer screening product.
The collaboration will harness Thermo Fisher’s powerful technologies, instrumentation, and information translation systems to enable Mainz Biomed to develop the proprietary assays for its mRNA-based next-generation CRC screening tests.
Mainz Biomed says its flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, demonstrating significant clinical success in both US and European trials.
As part of the collaboration, Mainz Biomed says the testing solutions for the assay are being developed in its laboratories in Mainz, Germany.
FDA Clears Omron’s AI-Based Home Blood Pressure Monitor
The US FDA has granted de novo authorization to an Omron home blood pressure monitor integrating AI technology, the company announced 14 November. The monitors feature an AI-powered algorithm, IntelliSense AFib, that checks blood pressure measurements against more than 300 data points to automatically detect leading stroke cause atrial fibrillation.
The company described the authorization as a crucial step in the fight against the growing AFib epidemic. In clinical research published in the October 2024 Heart Rhythm Journal, the Omron monitors showed a sensitivity of 95% and a specificity of 98% for detection of AFib.
“Omron Healthcare is making AFib screening a more integral part of our blood pressure monitoring experience as part of our Going for Zero mission to eliminate heart attack and stroke,” said Omron Healthcare President and CEO Ranndy Kellogg. “AFib is a serious condition that is under-discussed, under-checked and underdiagnosed. We want to change that.”
Omron plans to launch blood pressure monitors featuring Intellisense across the US in early 2025.
Ceribell Gets Green Light To Operate From VA
Ceribell announced it received authority to operate from the Department of Veterans Affairs, which means it can fully deploy its point-of-care EEG technology and leverage VA Wi-Fi networks and enable remote access to EEG reports and sharing EEG data between VA locations.
Ceribell has been used in certain VA facilities since 2018. The new authority from the VA allows it to broaden its use at VA hospitals to manage neurological emergencies by supporting timely interventions, the company said.
Death Prompts Medical King To Recall Adult Bed Rails
Following the death of a resident in a care facility, Medical King issued a recall of its adult bed assistance rails, according to the US Consumer Product Safety Commission.
In total, around 222,000 rails of three different models were recalled due to the risk of entrapment and asphyxia from users becoming stuck in the rail or between the rail and the mattress.
According to the recall notice, this is how a 66-year-old man in a South Carolina residential care facility died last year.
The company says consumers using the recalled beds are urged to immediately stop and contact Medical King for a free repair kit or replacement.
Manufactured in China, the recalled rails were sold online from January 2020 through March 2024 at Amazon.com, Walmart.com, Target Plus, eBay, Kohls.com and medicalkingusa.com.