FDA
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Biologics
Congress should hold oversight hearings to ensure FDA prioritizes safety for biosimilars
By James Weisman The Food and Drug Administration recently approved the first in a new category of biologic drugs known…
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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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Hospitals
FDA Files Consent Decree Against Medtronic and CEO Omar Ishrak
The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of…
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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
Congress Should Hold Oversight Hearings to Ensure FDA Prioritizes Safety for Biosimilars | Commentary
By James Weisman The Food and Drug Administration recently approved the first in a new category of biologic drugs known…
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Extremities
FH Ortho Receives FDA 510(K) Clearance for Its Arrow® Reverse Shoulder Long Keel & Short Keel Glenoid Base
CHICAGO–(BUSINESS WIRE)–FH Ortho, maker of thoughtfully designed orthopedic devices, instruments and procedures for orthopedic surgeons around the world, announces it…
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Hospitals
BioStructures announces FDA approval for bone graft solution
BioStructures recently announced they have received FDA clearance for their new Silhouette MCS Bone Graft. Indicated for better biologic responsiveness…
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Extremities
SI-BONE, Inc. Announces Appointment of Fidelity Health Insurance Services, LLC’s Martin Watson to Board of Directors
SAN JOSE, Calif., April 21, 2015 — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse…
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Hospitals
UNITED SPINAL URGES CONGRESS TO HOLD OVERSIGHT HEARINGS ON BIOSIMILAR MEDICINES TO ENSURE FDA PRIORITIZES SAFETY
WASHINGTON, April 16, 2015 /PRNewswire-USNewswire/ — United Spinal Association, a national organization dedicated to enhancing the quality of life of all people living…
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Hospitals
FDA clears iPad app for pre-operative surgical planning
Israel-based Voyant Health, a subsidiary of Germany-based medical technology company Brainlab, received FDA clearance for its iPad app, called TraumaCad Mobile, which…
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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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Financial
K2M Announces Enhanced Complex Spine Portfolio With Addition of Its Innovative NILE(TM) Alternative Fixation Spinal System
LEESBURG, Va., March 25, 2015 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global medical…
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