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Orthovita, Inc, a developer of orthopedic biomaterials, reported today that it has obtained pre-market approval (PMA) from the U.S. Food and Drug Administration to market its VITAGEL surgical hemostat.
Medtronic Inc. revealed regulatory approval from the government of the People's Republic of China for selling the Endeavor drug-eluting coronary stent system in that country.
The Food and Drug Administration (FDA) San Francisco District, in cooperation with AdvaMed's Medical Technology Learning Institute,
is announcing a public workshop on FDA device regulations.
The FDA and the National Institute for Occupational Safety and Health (NIOSH) have updated their previous recommendations on the use of sealing-type washers (reusable, metal-bound rubber seal) and crush-type gaskets (single use, not reusable) with oxygen regulators.
Vascular solutions has received conditional approval from the FDA in the form of an investigational device exemption (IDE) for its clinical study to support the use of Thrombin-VSI in its hemostatic devices, the firm has reported.
A Canadian company selling massage devices as over-the-counter medical treatments in the U.S. has drawn the ire of the Department of Justice (DOJ) and the FDA.
Phoenix Data Systems (PDS) and Trio Clinical Research (Trio) announce the launch of the Four Corners Clinical Alliance, a collaboration of specialized, clinical organizations offering new trial outsourcing alternatives to other clinical organizations.
Providence-based Afferent Corp., an early-stage medical device company focused on treating chronic neurologic dysfunction,
announced Tuesday that David M. Hable has joined the company as president and CEO.
NIR Diagnostics Inc., a leading-edge developer of handheld spectroscopy based medical instruments, announced today that it has entered into a definitive license and royalty agreement with Shaklee Corporation, a nutrition, skin care, and household products company, to develop, manufacture, distribute and market NIR Diagnostics' in-vivo light-based technology and the HemoNIR CO-oximeter device.
BioElectronics Corporation announced today that it has
signed an agreement with Adams BioMedical, Inc., Bremerton, Washington, to establish a national network of independent sales agents and distributors in the Podiatry, Orthotics and Prosthesis Markets.