The time to diagnosis of sepsis infection to a patient in the hospital can be critical, with underdiagnosis resulting in rapid deterioration, risk of organ damage and need for readmission, and overdiagnosis leading to the avoidable and sometimes serious health consequences of overtreating patients with broad-spectrum antibiotics.
In a new report from the U.S. International Trade Commission (USITC), concerns about global inequities accessing diagnostics and medicines for COVID-19 reveal that there are varied and divergent opinions on whether the intellectual property (IP) protections that support the development of new medicines may also act as a barrier to access, particularly in developing countries. In December 2022, U.S. Trade Representative Katherine Tai asked the USITC to respond and identify significant data and information gaps.
The U.S. Congress passed a five-year reauthorization of the Medical Device User Fee Amendment (MDUFA) agreement, the fifth iteration of this user-fee agreement since the system's implementation in 2002, after many months of back and forth with the med-tech industry. The extension passed as part of a temporary spending bill needed to avoid a partial government shutdown ahead of Friday’s deadline. The spending bill passage gives lawmakers a reprieve until after the midterm elections when they'll need to figure out a longer-term funding plan for the fiscal year ending Sept. 30, 2023.
Keeping you up to date on recent developments in orthopedics, including: Skin and bones repaired by bioprinting during surgery; Researchers use AI to detect wrist fractures; Smart Score quantifies clinical outcomes for shoulder arthroplasty patients.
Keeping you up to date on recent developments in orthopedics, including: 3D biomaterial used as 'sponge' for stem cell therapy to reverse arthritis; New biomaterial regrows blood vessels and bone, RCSI research; Without major changes, gender parity in orthopedic surgery will take two centuries.
Keeping you up to date on recent developments in orthopedics, including: X-rays confirm promise of new luminescent markers; Pillar of support: Breakthrough discovery could speed up bone implant recovery; New biosealant can stabilize cartilage, promote healing after injury.
Keeping you up to date on recent developments in orthopedics, including: New study expands evaluation of gene therapy for spinal muscular atrophy; High risk of AKI in patients undergoing treatment for infected total knee replacement; Tadpole nerve regeneration capacity provides clue to treating spinal cord injury.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: COVID-19 inventions included in USPTO awards program; First thrombosis incident reported in Australia; FDA revises Moderna EUA; GAO refuses to reconsider VA challenge.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MDIC accepting applications for the ASC pilot study.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.
