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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.
Keeping you up to date on recent developments in orthopedics, including: Scientists use nanotechnology to detect bone-healing stem cells; Premia reports FDA breakthrough device designation for Its Tops system; 'Break a leg' not so lucky when it leads to limb deformities.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, other stent graft products in line for FDA panel safety probe; New conditions imposed on vaccine authorization; MRNA vaccine efficacy holds in real world; STIs on the rise in U.S.
