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Proximate Concepts Receives ISO 13485:2016 Certification, Expands Education and Scholarly Publications With iNPLANT Funnel

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ALLENDALE, N.J., March 17, 2021 /PRNewswire/ — iNPLANT LLC, a medical device company and manufacturer of the iNPLANT Funnel, announced today that its parent company, Proximate Concepts LLC, has been awarded ISO13485:2016 certification for Medical Device and Quality Management Systems from SGS, the world’s leading inspection, verification, testing and certification company. This ISO designation indicates that Proximate Concepts meets or exceeds the stringent quality standards required in the medical device industry.

Proximate Concepts/iNPLANT Receives ISO 13485:2016 Certification

The company’s CEO, Paul Rosenberg, MD, explained, “Our team is proud and humbled to be awarded this certification, which illustrates Proximate Concepts’ ongoing commitment to innovation and quality in the aesthetic plastic surgery community.” The scope of ISO 13485:2016 certification includes design, development, quality assurance, quality management, product safety, customer service, and quality improvement.

“We are beyond excited to be at the forefront of aesthetic surgery innovation with this important ISO certification and to be able to contribute to the academic education and clinical improvement of outcomes for our colleagues in plastic surgery,” explained Dr. Rosenberg. Toward this end, we are pleased to share that an article featuring the double loading technique with the iNPLANT Funnel, by Dr. Paul Rosenberg and President of the Aesthetic Surgery Research and Education Foundation (ASERF) Dr. Luis Rios, has just published in the award-winning open access journal Aesthetic Surgery Journal Open Forum, entitledDouble Loading of Breast Implants in Aesthetic and Reconstructive Plastic Surgery With the iNPLANT Funnel.” The article and clinical videos illustrate the technical benefits of the iNPLANT funnel.

About iNPLANT LLC and Proximate Concepts LLC

iNPLANT LLC and Proximate Concepts design and develop surgical devices with a particular focus on the plastic surgery arena. Their flagship product, the iNPLANT funnel, is a disposable protective sleeve that permits the rapid and “no-touch” delivery of breast implants in patients undergoing cosmetic and reconstructive breast surgery, that contributes to lower complication rates. The interior surface of the device is coated with a lubricious substance which, when activated, dramatically reduces friction on delivery of the implant, avoids contact of the implant with the patient’s skin surface, and minimizes contact between the implant and any bioactive substances on or around the operative site. iNPLANT LLC holds numerous US and international patents on several other devices in various stages of development. The launch of their novel suction drain system, FlatVac, is expected in Q3 of 2021. As with the iNPLANT funnel, FlatVac will also be manufactured under contract with Proximate Concepts LLC.

For more information, visit www.inplantfunnel.com.

Contact: Brittany Garabed, 201-913-8833, bgarabed@.inplantfunnel.com

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/proximate-concepts-receives-iso-134852016-certification-expands-education-and-scholarly-publications-with-inplant-funnel-301249573.html

SOURCE iNPLANT LLC

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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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