FDA Center for Devices and Radiological Health

Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine® IMA203 TCR-T Monotherapy

Retrieved on: 
Tuesday, October 24, 2023

IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.

Key Points: 
  • IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.
  • “The FDA RMAT designation for multiple indications underscores the broad potential of IMA203 and the benefits it may provide for advanced-stage solid tumor patients.
  • This is an important regulatory milestone and a recognition of our clinical development progress for this program,” said Cedrik Britten, Chief Medical Officer of Immatics.
  • As of Sep 30, 2023, the U.S. FDA has received at least 238 requests for RMAT designations and granted 922.

Introducing AAMI neXus, the Evolved International Standards Conference

Retrieved on: 
Monday, October 16, 2023

Held from February 20 to 23, 2024, at the Omni Shoreham Hotel in Washington, D.C., AAMI neXus takes the place of the International Standards Conference (ISC).

Key Points: 
  • Held from February 20 to 23, 2024, at the Omni Shoreham Hotel in Washington, D.C., AAMI neXus takes the place of the International Standards Conference (ISC).
  • Since 1991, ISC was the must attend conference for industry and regulatory leaders involved in the development and adoption of medical device standards.
  • AAMI neXus features ISC’s previous programming but includes a new focus on applying medical device standards.
  • Robert Burroughs, AAMI chief learning and development officer said, “We’re excited to bring the same focus from ISC to AAMI neXus but to add material on standards application.

OrthoPediatrics Joins Alliance for Pediatric Device Innovation

Retrieved on: 
Thursday, October 12, 2023

WARSAW, Ind., Oct. 12, 2023 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS) a company focused exclusively on advancing the field of pediatric orthopedics, has announced a strategic partnership with Children’s National Hospital in Washington, DC under the “Alliance for Pediatric Device Innovation” (APDI), to advice the development and commercialization of medical devices designed for children.

Key Points: 
  • WARSAW, Ind., Oct. 12, 2023 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS) a company focused exclusively on advancing the field of pediatric orthopedics, has announced a strategic partnership with Children’s National Hospital in Washington, DC under the “Alliance for Pediatric Device Innovation” (APDI), to advice the development and commercialization of medical devices designed for children.
  • The Company will serve as APDI’s strategic advisor and role model for device innovators whose primary focus is children.
  • New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.
  • “Children’s National looks forward to continuing our work as a champion for medical device innovation for children.

FDA Establishes New Advisory Committee on Digital Health Technologies

Retrieved on: 
Wednesday, October 11, 2023

SILVER SPRING, Md., Oct. 11, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.

Key Points: 
  • SILVER SPRING, Md., Oct. 11, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.
  • The Digital Health Advisory Committee will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency's understanding of the benefits, risks, and clinical outcomes associated with use of DHTs.
  • To support the development of safe and effective digital health technologies while also encouraging innovation, the FDA will solicit views from the committee, which will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds.
  • Those interested in serving or nominating a representative to serve as a voting or non-voting member of the FDA's Digital Health Advisory Committee, may either submit nominations electronically by accessing the FDA Advisory Committee Membership Nomination Portal or by mail.

Frost & Sullivan Launches the EmpowerHer Program to Bridge the Growth Gap in Women's Health

Retrieved on: 
Tuesday, October 10, 2023

SAN ANTONIO, Oct. 10, 2023 /PRNewswire/ -- Frost & Sullivan, a renowned leader in fostering innovation and driving transformative change, proudly announces the launch of its groundbreaking "EmpowerHer" Growth Council Think Tank series. This initiative, launched in July 2023, is dedicated to tackling the monumental growth gap in women's health, which currently stands at a staggering $17 trillion. To address this complex issue, Frost & Sullivan has brought together a diverse array of stakeholders, including experts, thought leaders, industry professionals, and key policymakers.

Key Points: 
  • This initiative, launched in July 2023, is dedicated to tackling the monumental growth gap in women's health, which currently stands at a staggering $17 trillion.
  • The growth gap in women's health is a multifaceted challenge rooted in three critical areas: a lack of comprehensive clinical research, limited access to healthcare, and insufficient funding for women's health technology.
  • Recognizing that closing this gap requires a collective effort from society as a whole, Frost & Sullivan has taken a bold step forward with its Growth Council Think Tanks.
  • For more information about Frost & Sullivan's Women's Health Program and the Growth Council Think Tanks, click here

Frost & Sullivan Launches the EmpowerHer Program to Bridge the Growth Gap in Women's Health

Retrieved on: 
Tuesday, October 10, 2023

SAN ANTONIO, Oct. 10, 2023 /PRNewswire/ -- Frost & Sullivan, a renowned leader in fostering innovation and driving transformative change, proudly announces the launch of its groundbreaking "EmpowerHer" Growth Council Think Tank series. This initiative, launched in July 2023, is dedicated to tackling the monumental growth gap in women's health, which currently stands at a staggering $17 trillion. To address this complex issue, Frost & Sullivan has brought together a diverse array of stakeholders, including experts, thought leaders, industry professionals, and key policymakers.

Key Points: 
  • This initiative, launched in July 2023, is dedicated to tackling the monumental growth gap in women's health, which currently stands at a staggering $17 trillion.
  • The growth gap in women's health is a multifaceted challenge rooted in three critical areas: a lack of comprehensive clinical research, limited access to healthcare, and insufficient funding for women's health technology.
  • Recognizing that closing this gap requires a collective effort from society as a whole, Frost & Sullivan has taken a bold step forward with its Growth Council Think Tanks.
  • For more information about Frost & Sullivan's Women's Health Program and the Growth Council Think Tanks, click here

FDA awards nearly $7.5 million to pediatric device consortium led by Children’s National Hospital

Retrieved on: 
Tuesday, September 19, 2023

WASHINGTON, D.C., Sept. 19, 2023 (GLOBE NEWSWIRE) -- To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital .

Key Points: 
  • WASHINGTON, D.C., Sept. 19, 2023 (GLOBE NEWSWIRE) -- To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital .
  • New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.
  • Along with Children’s National, APDI consortium members include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center and Medstar Health Research Institute.
  • Eskandanian says the new Children’s National Research and Innovation Campus provides the ideal environment for the collaborative work needed to advance pediatric innovation.

Elanco Launches Varenzin™-CA1 (molidustat oral suspension) – the First-of-its-Kind Oral Treatment for Anemia in Cats with Chronic Kidney Disease

Retrieved on: 
Thursday, September 7, 2023

CKD is common among mature and senior cats, occurring in about 15-30% of feline patients over 12 years old.

Key Points: 
  • CKD is common among mature and senior cats, occurring in about 15-30% of feline patients over 12 years old.
  • “Chronic kidney disease is not curable, so veterinarians and pet owners are focused on improving quality of life and slowing disease progression in affected cats,” said Dr. Melinda Wood, Specialty Consulting Veterinarian at Elanco.
  • Varenzin-CA1 is indicated for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats.
  • Elura has not been evaluated in cats younger than 5 months of age or in breeding, pregnant or lactating cats.

Healthcare Logistics Market to increase by USD 87.9 billion during 2022 to 2027; Growing global pharmaceutical sales to drive the growth- Technavio

Retrieved on: 
Tuesday, September 5, 2023

NEW YORK, Sept. 5, 2023 /PRNewswire/ -- The healthcare logistics market size is expected to grow by USD 87.9 billion between 2022 and 2027.

Key Points: 
  • NEW YORK, Sept. 5, 2023 /PRNewswire/ -- The healthcare logistics market size is expected to grow by USD 87.9 billion between 2022 and 2027.
  • The report analyses the market size and growth and provides accurate predictions on the growth of the market.
  • View a PDF Sample
    Growing global pharmaceutical sales drives the growth of the healthcare logistics market.
  • The growth of the global market can be attributed to factors such as the growing geriatric population and new product launches by pharmaceutical manufacturers.

Digital Medicine Society Report Benchmarks Industry Needs for Regulatory Science and Policy Innovation

Retrieved on: 
Tuesday, August 29, 2023

BOSTON, Aug. 29, 2023 /PRNewswire/ -- Today, the Digital Medicine Society (DiMe) released findings from a digital health industry needs assessment to identify 1) the drivers of successful digital health product development and adoption, and 2) the regulatory policy needed to facilitate these drivers. 86 industry experts from 66 organizations spanning the digital health product development market participated in a series of three workshops and an industry benchmarking survey. The resulting report has been shared with the Food and Drug Administration's (FDA) Digital Health Center of Excellence in support of their commitment to medical device innovation to protect and promote public health.

Key Points: 
  • BOSTON, Aug. 29, 2023 /PRNewswire/ -- Today, the Digital Medicine Society (DiMe) released findings from a digital health industry needs assessment to identify 1) the drivers of successful digital health product development and adoption, and 2) the regulatory policy needed to facilitate these drivers.
  • 86 industry experts from 66 organizations spanning the digital health product development market participated in a series of three workshops and an industry benchmarking survey.
  • To date, FDA's Center for Devices and Radiological Health (CDRH), which houses the Digital Health Center of Excellence, has released 24 guidance documents with digital health content.
  • DiMe's report outlines the top industry needs to provide clear direction on where regulatory advancements can have the greatest impact.