All posts in Regulatory
57 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in March
The Food and Drug Administration issued 57 orthopedic- and spine-related 510(k) clearances in March, according to an FDA report. 1. MSA Hip System from Global Manufacturing Technology. 2. Laguna Pedicle Screw System from Phygen. 3. Concorde Bullet Cage System from ...
ArthroCare Announces Settlement of SEC Investigation
ArthroCare Corp. (NASDAQ: ARTC) (the "Company") announced today that it has entered into a settlement with the United States Securities and Exchange Commission ("SEC") that fully resolves the
Judge strikes down healthcare reform law
By Tom Brown MIAMI | Mon Jan 31, 2011 4:45pm EST (Reuters) - A federal judge in Florida struck down President Barack Obama's landmark healthcare overhaul as unconstitutional on Monday, in the
Alphatec Spine, Inc. 1/11/11
WARNING LETTER VIA UPS EXPRESS JAN 11 2011 Paula Morgan, RAC Senior Director, Regulatory Affairs Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Dear Ms. Morgan: The Food and Drug Administration (FDA)
49 Orthopedic and Spine Devices Receive FDA 510 (k) Clearance in December
The Food and Drug Administration issued 49 orthopedic- and spine-related 510(k) clearances in December, according to an FDA report. 1. NuVasive Spherx II-Mas Deformity Spinal System from NuVasive. 2. Concorde
Stryker Sues Zimmer Over U.S. Wound-Treatment Device Patents
By: Susan Decker Dec. 14 (Bloomberg) -- Stryker Corp., a maker of artificial knees and hips, filed a patent-infringement lawsuit against Zimmer Holdings Inc. to block sales of a
Minnesota senators recruit buddies to pressure FDA over 510(k)
As the duly elected representatives of the great state of Minnesota, Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry,
Exactech announces resolution of government investigation
Exactech, Inc., a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced in a press release that it has
10 Orthopedic and Spine Devices Recently Launched or Approved
Here are ten device companies that recently launched orthopedic products or received FDA approval for the products. 1. Integra LifeSciences' Ruggles kerrison rongeurs. The Ruggles kerrison rongeurs is a
Biomet Receives FDA Warning Letter, Seeks Resolution with FDA
WARSAW, Ind. - (Business Wire) On July 28, 2010, Biomet received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding the Signature™ Personalized Patient Care
Device makers under scrutiny in international bribery beef
Federal investigators are looking into payments to foreign physicians by at least three major medical device makers and several pharmaceutical firms, examining whether the practice runs afoul of
FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP)
Indiana medical device makers say fight isn’t over
It was a rare, stinging setback for medical device and supply companies, including dozens in Indiana that make hospital beds, stents, biopsy needles, artificial joints and thousands
ArthroCare (ARTC) entered a Settlement Agreement with Progressive Casualty Insurance
Click Here for Complete Filing UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549
Legislation circulating in the Mass. House of Representatives would kill the 2008 gift ban governing industry relationships with physicians.
An omnibus economic development bill wending its way through the Mass. House of Representatives would put paid to the Bay State's two-year-old "gift ban" governing the relationship between