FDA
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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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Biologics
Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease
– P-15L Bone Graft is currently being studied in the Company’s ASPIRE IDE clinical trial – WESTMINSTER, Colo., April 29, 2021 /PRNewswire/…
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Regulatory
Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis
SAN CARLOS – 31 March 2021 – Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal…
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Regulatory
Premia Spine Announces FDA Breakthrough Device Designation for Its TOPS™ Spinal Arthroplasty System
First-of-a-kind system designed to offer new treatment option for patients with spinal stenosis and spondylolisthesis March 31, 2021 NORWALK, Conn.–(BUSINESS…
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COVID-19
FDA says to limit mask decontamination to 4 cycles
January 22, 2021 By Nancy Crotti Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations…
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Biologics
Organogenesis ReNu® Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation For Osteoarthritis of the Knee
FDA Determines ReNu Preliminary Clinical Evidence Indicates Potential to Address Unmet Medical Needs for the Management of Symptoms Associated with…
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COVID-19
SCONE Medical Receives FDA Emergency Use Authorization for Novel Aerosol Infection Containment Device
PHOENIX, Jan. 4, 2021 /PRNewswire/ — As the world faces a new era of emerging and re-emerging infectious diseases, new technologies are…
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Recon
FDA Authorizes Marketing of New Implant to Repair a Torn ACL
SILVER SPRING, Md., Dec. 16, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review…
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Hospitals
Vuzix Receives Follow-on Smart Glasses Orders from Pixee Medical to Support European Commercialization of their Augmented Reality Smart Glasses Solution for Orthopedic Surgery
ROCHESTER, N.Y., Dec. 2, 2020 /PRNewswire/ — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or, the “Company”), a leading supplier of Smart Glasses and Augmented Reality (AR)…
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Extremities
Full-Service Product Development: BAAT Medical Products Hits Home Runs
Elizabeth Hofheinz, M.P.H., M.Ed. In today’s tight climate, there is less room than ever for wasted effort. However, many medical…
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