Anatomy

Zimmer Biomet Receives FDA Clearance for ROSA® Shoulder System - the World's First Robotic Assistant for Shoulder Replacement Surgery

Retrieved on: 
Thursday, February 22, 2024

WARSAW, Ind., Feb. 22, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the ROSA® Shoulder System for robotic-assisted shoulder replacement surgery. ROSA Shoulder is the world's first robotic surgery system for shoulder replacement, and the fourth application for the Company's comprehensive ROSA® Robotics portfolio, which includes the ROSA® Knee System for total knee arthroplasty and ROSA® Hip System for total hip replacement.

Key Points: 
  • WARSAW, Ind., Feb. 22, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the ROSA® Shoulder System for robotic-assisted shoulder replacement surgery.
  • ROSA Shoulder is the world's first robotic surgery system for shoulder replacement, and the fourth application for the Company's comprehensive ROSA® Robotics portfolio, which includes the ROSA® Knee System for total knee arthroplasty and ROSA® Hip System for total hip replacement.
  • ROSA Shoulder strengthens Zimmer Biomet's innovative shoulder implant portfolio, which includes the Identity Shoulder System, and joins ZBEdge™ Dynamic Intelligence™ , which has the power to enhance the company's cutting-edge digital technologies, robotics and implant solutions.
  • "We are proud and excited to be the first company in the world to deliver a robotic surgical assistant for anatomic and reverse shoulder replacement surgery," said Ivan Tornos, President and Chief Executive Officer at Zimmer Biomet.

Sira Medical Wins FDA Clearance for Augmented Reality Preoperative Surgical Planning Software

Retrieved on: 
Wednesday, February 21, 2024

SAN FRANCISCO, Feb. 21, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration granted Sira Medical 510(k) clearance for its augmented reality preoperative surgical planning application, which provides clinicians with advanced imaging to assist in making key patient management decisions.

Key Points: 
  • SAN FRANCISCO, Feb. 21, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration granted Sira Medical 510(k) clearance for its augmented reality preoperative surgical planning application, which provides clinicians with advanced imaging to assist in making key patient management decisions.
  • The lack of clarity forces surgeons to make critical decisions on the fly during surgery, which can lead to errors and inefficiencies.
  • To validate its technology, Sira Medical has conducted multiple peer-reviewed studies which demonstrate greater surgical efficiency by reducing operating time, and a preference for using augmented reality models for surgical planning.
  • "By achieving this major milestone and attracting positive reviews from surgeons, we believe Sira Medical is poised to become a leader in the medical imaging sector."

"This Penis Business: A Memoir" Chronicles the Life Events That Compelled Georganne Chapin to Make Ending Circumcision Her Life's Work

Retrieved on: 
Tuesday, February 20, 2024

TARRYTOWN, N.Y., Feb. 20, 2024 /PRNewswire-PRWeb/ -- Chapin, Co-Founder and Executive Director of Intact America, Exposes the Big Business of Medical Circumcision and the Cruel Absurdity of Circumcising Baby Boys for No Medical Reason

Key Points: 
  • I chose to write a memoir about why I believe cutting the genitals of children who cannot consent is a massive human rights abuse," says Chapin.
  • But it wasn't until she went to law school mid-career and studied bioethics that Chapin turned to intactivism, the human rights movement dedicated to ending routine circumcision of baby boys in the United States.
  • "I wanted to write a book exposing the multi-billion-dollar medical circumcision business in the United States.
  • "This Penis Business" is available from Amazon , Barnes & Noble , and Bookshop , as well as local bookstores near you.

University of Saarland chooses Sectra Education Portal to bridge the gap to clinical reality for radiographer students

Retrieved on: 
Monday, February 19, 2024

LINKÖPING, Sweden, Feb. 19, 2024 /PRNewswire/ -- International medical imaging IT and cybersecurity company Sectra (STO: SECT B) will provide the University of Saarland with its platform for medical education — Sectra Education Portal.

Key Points: 
  • LINKÖPING, Sweden, Feb. 19, 2024 /PRNewswire/ -- International medical imaging IT and cybersecurity company Sectra (STO: SECT B) will provide the University of Saarland with its platform for medical education — Sectra Education Portal.
  • By adding Sectra's solution for medical education to their existing Sectra enterprise imaging solution, they are bridging the gap between education and the clinical reality.
  • Saarland University (UdS) is a public research university organized into six faculties covering all major scientific fields.
  • One of these being the Faculty of Medicine, which is located together with Saarland University Hospital (UKS) in Homburg/Saar in Germany.

KBRA Releases 12 Things in Credit: January 2024

Retrieved on: 
Thursday, February 15, 2024

KBRA releases topical and timely commentary on credit markets, compiled from our weekly podcast, 3 Things in Credit, hosted by our Chief Strategist, Van Hesser.

Key Points: 
  • KBRA releases topical and timely commentary on credit markets, compiled from our weekly podcast, 3 Things in Credit, hosted by our Chief Strategist, Van Hesser.
  • Among the wide-ranging topics Van has addressed over the past month are what rising credit card delinquencies signal, the anatomy of a soft landing, and the significance of nonbanks’ growing share of lending.
  • Each week, we dig into and provide perspective on issues credit-market participants care about.
  • And look for our monthly published recap to catch up on what you might have missed.

Subaru of America and AAAS Announce Winners of 2024 Prize for Excellence in Science Books

Retrieved on: 
Wednesday, February 14, 2024

CAMDEN, N.J. and WASHINGTON, Feb. 14, 2024 /PRNewswire/ -- Subaru of America, Inc. , and the American Association for the Advancement of Science , the world's largest general scientific society and publisher of the Science family of journals, today announced the 2024 winners of the AAAS/Subaru Prize for Excellence in Science Books .

Key Points: 
  • CAMDEN, N.J. and WASHINGTON, Feb. 14, 2024 /PRNewswire/ -- Subaru of America, Inc. , and the American Association for the Advancement of Science , the world's largest general scientific society and publisher of the Science family of journals, today announced the 2024 winners of the AAAS/Subaru Prize for Excellence in Science Books .
  • "AAAS believes that, through good science books, this generation, and the next, will have a better understanding and appreciation of science," said Sarah Ingraffea, the AAAS/Subaru Book Prize Award manager at AAAS.
  • Awards are given in four categories: Children's Science Picture Book, Middle Grades Science Book, Hands-on Science Book and Young Adult Science Book.
  • With today's announcement, the AAAS/Subaru Prize for Excellence in Science Books has now honored 76 books and more than 100 authors and illustrators.

Laura Davis Joins VisionAir Solutions as Executive Director of Education

Retrieved on: 
Wednesday, February 14, 2024

CLEVELAND, Feb. 14, 2024 /PRNewswire/ -- VisionAir Solutions, a Cleveland, Ohio-based company that creates patient-specific airway stents announced that Laura Davis has joined its team as Executive Director of Education.

Key Points: 
  • Business development and sales leader Laura Davis joins VisionAir Solutions team as Executive Director of Education.
  • CLEVELAND, Feb. 14, 2024 /PRNewswire/ -- VisionAir Solutions, a Cleveland, Ohio-based company that creates patient-specific airway stents announced that Laura Davis has joined its team as Executive Director of Education.
  • Business development and sales leader Laura Davis joins VisionAir Solutions team as Executive Director of Education.
  • Laura joins VisionAir from an impressive background as a sales leader and education consultant.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

Butterfly Network Launches Next-Generation Butterfly iQ3™ in the United States

Retrieved on: 
Tuesday, February 13, 2024

Butterfly iQ3 is powered by the Company’s most advanced semiconductor chip with a data transfer rate that is double that of its predecessor.

Key Points: 
  • Butterfly iQ3 is powered by the Company’s most advanced semiconductor chip with a data transfer rate that is double that of its predecessor.
  • View the full release here: https://www.businesswire.com/news/home/20240213652085/en/
    The Butterfly iQ3 device featuring a new user-centric ergonomic design that is smaller, lighter and better weight distributed.
  • The introduction of Butterfly iQ3 includes a focus on higher precision capabilities for cardiovascular point-of-care ultrasound applications to inform complex decisions.
  • Butterfly Network’s Chief Medical Officer, John Martin, MD, concludes, “With Butterfly iQ3, we set out to give clinicians the clear leading solution in point-of-care ultrasound.

Medacta to Feature GMK SpheriKA and Innovative Personalized Solutions at AAOS 2024

Retrieved on: 
Monday, February 12, 2024

“Improving patient outcomes with innovative and sustainable solutions is our highest priority at Medacta,” stated Francesco Siccardi, Chief Executive Officer of Medacta.

Key Points: 
  • “Improving patient outcomes with innovative and sustainable solutions is our highest priority at Medacta,” stated Francesco Siccardi, Chief Executive Officer of Medacta.
  • Attendees will have the opportunity to learn more about GMK SpheriKA.
  • “I am excited for the opportunity to share the GMK SpheriKA technique with AAOS attendees,” said Stephen Howell, MD.
  • All Medacta products, including GMK SpheriKA and NextAR, are supported by the comprehensive, tailored educational offerings provided by the M.O.R.E.