FDA Approval
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Hospitals
Another FDA Approval For Spinal Cord Stimulation
Spinal Cord Stimulation has been around since 1989 as a treatment for chronic pain, and companies that make the devices…
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Financial
Wright Medical delays Augment timeline
By Brad Perriello Wright Medical says it now expects its Augment bone graft to win FDA approval in the 2nd…
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Hospitals
What are the FDA Usability Testing Requirements for Device Approval?
By Thomas Klein In a government-sponsored workshop on usability in 2011, the FDA’s 510(k) team leader regarding human factors presented…
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Extremities
Cartiva Announces 510(k) Clearance for ProxiFuse Hammertoe Correction System
ALPHARETTA, GA. — Cartiva, Inc., (the “Company”) a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and…
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Recon
EOS imaging Obtains FDA Approval for hipEOS, the First 3D Stereoradiographic Planning Software for Hip Arthroplasty
PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI), the pioneer in orthopaedic 2D/3D imaging, announced today that the U.S. Food and…
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Spine
SIGNUS receives clearance to launch MOBIS® II ST (Structural Titanium) interbody fusion device
“Intervertebral fusion implants made from structural titanium (ST Line™) are designed to improve bone ingrowth and ongrowth” Alzenau (Germany) September 29, 2014…
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Spine
Nanovis Spine, LLC receives FDA 510(k) clearance of its novel FortiCoreTM cervical and lumbar interbody fusion device platform
Carmel, Ind. (September 22, 2014) – Nanovis Spine, LLC (Nanovis) announced today that it has received U.S. Food and Drug…
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Life Spine® Announces FDA Clearance of LONG BOW™ Expandable Lateral Interbody System
HOFFMAN ESTATES, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment…
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Extremities
Arthrosurface’s KISSloc Suture System receives FDA approval
Arthrosurface, Inc. (www.arthrosurface.com), a developer of novel joint technologies, has received FDA 510(k) clearance for the KISSloc Suture System, a…
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Spine
MEDICREA’s K-JAWS(R) Obtains FDA Approval for Its Marketing in the United States
LYON, France--(BUSINESS WIRE)--August 01, 2014-- Regulatory News: The MEDICREA Group: (Paris:ALMED) (FR0004178572-ALMED), which specializes in the development of innovative surgical…
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Uncategorized
Report: Medtech M&A exits don’t hinge on FDA approval
July 31, 2014 by Arezu Sarvestani Medical device startups face significant headwinds in finding funding and getting to an exit, but at…
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Financial
Report: Medtech M&A exits don’t hinge on FDA approval
July 31, 2014 by Arezu Sarvestani Medical device startups face significant headwinds in finding funding and getting to an exit,…
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Spine
Medtronic (MDT) PRESTIGE LP Cervical Disc System Approved by FDA
Medtronic, Inc. (NYSE: MDT) announces that it has received approval from the U.S. Food and Drug Administration (FDA) to market the…
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Robotics
Blue Belt Technologies Receives 510(k) Clearance for Patellofemoral Joint Replacement Application
MINNEAPOLIS–(BUSINESS WIRE)–Blue Belt Technologies has received FDA clearance to market their latest surgical application for the Navio® Surgical System, patellofemoral…
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Baxano Surgical Receives 510(k) Clearance for the Avance MIS Pedicle Screw System
RALEIGH, N.C., April 10, 2014 (GLOBE NEWSWIRE) — Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing…
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