FDA
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Recon
Hip Innovation Technology Receives FDA Investigational Device Exemption (IDE) Approval to Initiate Landmark Study of its Reverse Hip Replacement System
HIT’s Reverse Hip Replacement System may Revolutionize Total Hip Replacement Surgery BOCA RATON, Fla., Jan. 18, 2022 /PRNewswire/ — Hip Innovation Technology, LLC…
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Regulatory
FDA authorizes COVID-19 pills from Pfizer and Merck
The treatment has been cleared for anyone 12 years old and older who is at high risk for severe COVID-19,…
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Extremities
Paragon 28’s Patient Specific Titanium Talus Spacer Has Been Approved by the U.S. Food and Drug Administration
December 13, 2021 ENGLEWOOD, Colo.–(BUSINESS WIRE)–Paragon 28, Inc. (NYSE: FNA) announced today that it has received a supplemental approval order from…
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Regulatory
Amber Implants VCFix® spinal system receives US FDA Breakthrough designation
HAGUE, Netherlands, Oct. 5, 2021 /PRNewswire/ — Amber Implants, an innovative medical technology company developing next generation spinal implants for spinal injuries, today…
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COVID-19
Merck says new COVID-19 medication cuts the risk of hospitalization and death
Merck plans to submit an application for Emergency Use Authorization to the FDA soon based on these findings. October 4,…
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Financial
CMS wants to pull Trump-era pathway that speeds up Medicare coverage of breakthrough medical devices
by Robert King | Sep 13, 2021 The Biden administration wants to pull a controversial Trump-era regulation that would hasten Medicare coverage of…
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Spine
NuVasive Simplify Cervical Disc Data Published In International Journal Of Spine Surgery
Peer-reviewed data results from multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF SAN DIEGO, Sept. 9, 2021 /PRNewswire/ —…
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Biologics
Ortho Regenerative Technologies Announces Extension of FDA Clinical Hold of ORTHO-R Investigational New Drug Application
Most complex, and majority of additional information on characterization at point of care and CMC related data submitted accepted by…
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Biologics
Ortho Regenerative Technologies Receives Clinical Hold Letter From the U.S. FDA
Additional CMC related data and characterization requested by the FDACompany confident of providing requested information over the coming weeksPhase I/II…
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Regulatory
CUREXO’s spinal surgery robot, ‘CUVIS-spine’ acquired FDA (US) licensing
‘CUVIS-spine’ is available in all countries by acquiring the license from the FDA (US), Korea and Europe.‘CUVIS-spine’ reduces surgery duration with…
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Regulatory
MCRA CRO Assists Simplify Medical, Recently Acquired by NuVasive, on FDA-Approval for Two Level use of its Cervical Disc
– MCRA’s CRO assisted Simplify Medical, Inc. (Simplify Medical) with the conduct, execution and oversight of the clinical study, including…
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