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Catalyst OrthoScience Receives FDA 510(k) Clearance of Its Reverse Shoulder System

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The addition of the reverse shoulder system allows Catalyst to offer a broader shoulder portfolio and multiple arthroplasty options to shoulder surgeons across the U.S. Reverse shoulder arthroplasty is estimated to encompass more than 60 percent of the shoulder arthroplasty market.

“With the addition of our reverse shoulder system, Catalyst is now addressing the two fastest growing segments of the shoulder arthroplasty market – stemless anatomic and reverse TSA,” said Brian K. Hutchison, chairman and CEO of Catalyst. “This is beneficial for our distributors as well, who can now help surgeons more easily meet the needs of patients.”

Catalyst’s reverse shoulder system is a single-tray arthroplasty system that was engineered to combine the most beneficial and evidence-based attributes of reverse shoulder arthroplasty design. The system offers surgeon-targeted implant positioning, a streamlined and versatile system, and bone sparing implants.

The Catalyst reverse shoulder system is a total shoulder prosthesis designed for patients experiencing severe shoulder arthritis in conjunction with a grossly deficient or non-functional rotator cuff. In a reverse shoulder system, the design is inverted compared to a traditional anatomic total shoulder prosthesis where the articulating sphere is on the glenoid side of the joint and the mating insert is fixed into the humeral stem implant.

Catalyst is one of the fastest-growing players in the anatomic stemless total shoulder arthroplasty market with its Catalyst CSR™ Total Shoulder System. The Catalyst CSR system combines innovative components and unique instrumentation to bring about a precise, accurate restoration of the shoulder. It features a stemless, ellipsoid humeral component that is engineered to accurately replace the elliptical shape of the patient’s native non-spherical humeral head.

About Catalyst OrthoScience Inc.

Catalyst OrthoScience develops innovative medical solutions that make orthopedic surgery less invasive and more efficient for both surgeons and patients. Catalyst was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D., who saw the need to make shoulder replacement surgery less invasive and give patients a more natural-feeling shoulder after surgery.

The Catalyst CSR Total Shoulder System is unique, offering precision and accuracy in shoulder restoration while preserving the patient’s bone and soft tissue. The Catalyst CSR is a single-tray, bone-preserving total shoulder arthroplasty system containing a precision elliptical humeral head and less invasive glenoid component, using patented instrumentation designed for consistent anatomic joint line restoration and glenoid insertion. The Catalyst CSR system can be used in both inpatient and outpatient settings and was cleared for use by the FDA in 2016.

Catalyst OrthoScience has a growing portfolio of U.S. patents with several more pending nationally and internationally. The company is headquartered in Naples, Fla., and its products are available across the U.S. For additional information on the company, please visit www.CatalystOrtho.com/.

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Source: https://www.biospace.com/article/releases/catalyst-orthoscience-receives-fda-510-k-clearance-of-its-reverse-shoulder-system/?s=93

Medical Devices

New York Bone & Joint Specialists: New Invention Stops or Delays the Progression of Osteoarthritis of the Knee

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Source: https://infomeddnews.com/new-york-bone-joint-specialists/

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Medical Devices

Ping An AskBob Doctor’s Smart Imaging Model for Diagnosis of Pelvic and Hip Injuries is a Breakthrough for Artificial Intelligence

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April 1, 2021

Ping An Insurance (Group) Company of China, Ltd. “Ping An” announced that Ping An AskBob Doctor’s smart imaging model for diagnosing pelvic and hip injuries is the first of its kind to accurately detect all kinds of trauma-related findings simultaneously in X-ray images.

In a research paper published in the international journal Nature Communications, the model is shown to overcome the limitation of other artificial intelligence (AI) systems, which can only detect individual fractures.

The model, a deep learning algorithm, can help physicians make faster, more accurate diagnoses and save lives. Hip fractures mainly occur in elderly people and patients with major trauma. Although they are not directly fatal, complications can lead to a high mortality rate. Reducing the rate of missed diagnoses, improving the comprehensiveness of the detection, and providing accurate diagnoses is critical.

Ping An Health Technology Research Institute, Ping An Smart City, Ping An Good Doctor and the Department of Trauma and Emergency Surgery of Chang Gung Memorial Hospital in Taiwan jointly released the research paper “A scalable physician-level deep learning algorithm detects universal trauma on pelvic radiographs”. The research team gathered the pelvic X-ray data of 1,888 emergency room patients to evaluate the model’s performance in obtain the fracture results and locations. It achieved an overall accuracy of 92.4%. Compared with general clinical diagnoses, the model substantially improves detection accuracy, speeds up the treatment progress, improves the treatment effectiveness on high-risk patients, and reduces the economic cost to patients through earlier detection and treatment.

This is the first AI algorithm to detect all fracture types captured on the X-ray images, including, but not limited to, hip fractures, pelvic fractures, femoral fractures, hip dislocation and artificial joint peripheral fractures.

As of March, 2021, the AskBob Doctor AI pelvic trauma detection technology has been used in the real-life clinical environment in Chang Gung Memorial Hospital in Taiwan for nearly eight months. The results have shown that the misdiagnosis rate has significantly reduced. Since adopting the AI system, the misdiagnosis rate has dropped from 9.7% to 0.7% among emergency physicians, 11.3% to 1.58% among resident physicians and 6% to 0.5% among specialist physicians. The model has performed comparably to radiologists and certain orthopedic specialists in terms of quantitative indicators such as sensitivity and specificity.

The smart imaging model for the diagnosis of pelvis and hip injuries is Ping An’s latest achievement in smart imaging technology. Ping An’s smart imaging technology covers nine major systems of human body — the motor, digestive, respiratory, urinary, reproductive, endocrine, immune, nervous and cardiovascular systems. It supports various equipment including computed tomography (CT,) X-ray, ultrasound and fundus optical coherence tomography (OCT).

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Source: https://infomeddnews.com/ping-an-askbob-doctors-smart-imaging-model/

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Medical Devices

Sander de Vos Is Appointed Chief Business Officer of IME Medical

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April 1, 2021

Sander de Vos will be responsible for the worldwide roll-out of the company’s medical electrospinning strategy, based on IME’s ground-breaking MediSpin™XL industrial production platform.

Judith Heikoop, CEO of IME Medical Electrospinning said, “We at IME are thrilled to welcome Sander to our fast-growing team of professionals. Sander clearly brings a wealth of well-needed life science experience into the company, that will certainly be of key-value to the further development of our electrospun medical device franchises. Our aim is to become the first partner of choice worldwide for the development of a novel, groundbreaking class of medical devices and pharma products based on nanofibers. Our ever-growing portfolio of customers and partners includes the Medtech and Pharma industry, universities, hospitals, and medical institutes.”

Sander de Vos (46) is an accomplished executive with more than 15 years of leadership experience across healthcare and biotech commercial and business development positions. Prior to joining IME, Sander worked at Mimetas, an innovative Dutch start-up company providing novel human cell biology models for improved therapies, where he played a key role in expanding the collaborations with its pharma and biotech partners.

In previous roles, Sander led the commercial team of Isogen Life Science and acquired experience as an entrepreneur growing a private business. His commercial career started at Westburg Life Sciences and for more than 10 years he shaped and directed the sales strategy and commercial development of part of their life science business.

Sander has a background in molecular biology, co-developed a molecular diagnostic test for simultaneous detection of tick-borne pathogens, and contributed to the development of a vaccine against ticks at the Faculty of Veterinary Medicine of the Utrecht University.

Sander de Vos, Chief Business Officer of IME Medical Electrospinning, said: “With the potential of becoming the global leader in large-scale production of best-in-class nanofiber based medical devices and drug delivery solutions, I’m proud, gratified and delighted to become a member of the IME management team. The company’s technology enables faster and better recovery of tissues and body structures, and therefore IME is uniquely positioned to make a meaningful difference in the lives of patients.”

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Source: https://infomeddnews.com/sander-de-vos-ime-medical/

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Medical Devices

Dipti Itchhaporia, MD, FACC: New American College of Cardiology President

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April 1, 2021

Dipti Itchhaporia, MD, FACC, today begins her term as president of the American College of Cardiology.

During her one-year presidency, she will lead the over 54,000-member global organization in its mission to transform cardiovascular care and improve heart health.

“From the moment I became a Fellow of the ACC, I’ve been excited about being a part of this community and contributing to advancing the field of cardiology and the patients we serve,” Itchhaporia said. “I’m looking forward to connecting the cardiovascular community over the next year, as we emerge from a mostly virtual world, to make strides in our strategic priorities and improve the lives of heart disease patients. We must be prepared as a profession to embrace and move to center stage our solutions and vision of digital transformation and health equity.”

Itchhaporia is an interventional cardiologist who is the Eric and Sheila Samson Endowed Chair in Cardiovascular Health, director of disease management for Hoag’s Jeffrey M. Carlton Heart and Vascular Institute in Newport Beach, California, and associate professor of medicine at the University of California, Irvine. She has been a leader in the College for over 20 years, previously holding positions both nationally and in the ACC California Chapter.

Most recently, Itchhaporia held the position of ACC vice president. She previously served as a member of the ACC’s Board of Trustees and the Board of Governors, secretary of the ACC as chair of the Board of Governors, and president of the ACC California Chapter. She has also served on multiple ACC committees and helped to advance the College’s education, science and innovation efforts, including as a member of the ACC Lifelong Learning Oversight Committee, Science and Quality Committee, Governance Committee, Practice Administrator Workgroup and as an advisor for the ACC’s Innovation Program.

Itchhaporia’s professional interests include quality measurement and improvement in cardiovascular disease, focusing on emerging risk factors and medical and lifestyle interventions to prevent coronary heart disease. She is also extensively involved in advancing technology and innovations that will advance the digital transformation of cardiovascular medicine to ultimately improve the lives of patients and clinicians, while helping to achieve health equity.

Itchhaporia’s professional passions have led to leadership roles in advancing the ACC’s strategic priorities, including serving as chair of the ACC Board of Trustees Health Equity Task Force, which addresses issues of health disparities, the social determinants of health and improving access to care for underserved patients. Further work toward health equity will be at the forefront of her presidential year.

“Health equity has been a priority for the College for a long time and for the first time we are feeling like this could be actualized,” Itchhaporia said. “In cardiology we need to have the mindset to prioritize health equity issues, and I’m excited that this is in our reach.”

She received her medical degree from St. Louis University School of Medicine and completed her residency in internal medicine at Stanford University Medical Center. She then joined the general medicine faculty at the University of California, San Francisco (UCSF), ultimately pursuing a cardiology fellowship at Georgetown University and an interventional cardiology fellowship at Stanford University.

Other ACC officers for 2021-2022 are Vice President Edward T. A. Fry, MD, FACC; Board of Governors Chair Joseph Marine, MD, FACC; and Treasurer Christopher M. Kramer, MD, FACC.

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Source: https://infomeddnews.com/dipti-itchhaporia-president-acc/

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