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The FDA needs to evaluate data in two recent studies before it can determine the true risk of blood clots in patients implanted with drug-eluting stents, the agency said in a Sept. 14 statement.
To help device firms remain in compliance with Medicare and Medicaid regulations, AdvaMed is asking HHS' Office of Inspector General (OIG) for clearer guidance on physician investments in firms that make or distribute devices.
Seven separate clinical studies (all peer review published,including the Journal of Hypertension), conducted on over 250 participants, showed that the RESPeRATE medical device can lower blood pressure by up to 36 points systolic and 20 points diastolic.
Smith & Nephew's Endoscopy division announced the launch of its new DYONICS ARTHROPAK Customized Procedure Kits, which contain medical devices used in the most common arthroscopic procedures.
The only medical center to offer virtual-reality therapy for Sept. 11-related PTSD, NewYork-Presbyterian/Weill Cornell has proven the therapy effective and successfully treated patients since first offering it in 2002.
The Malaysian medical devices industry is expected to continue to register an average year-on-year growth of 8 per cent over the next few years, says the Association of Malaysian Medical Industries (AMMI).
The biotechnology industry is making another attempt to ease Sarbanes-Oxley (SOX) reporting and auditing requirements for smaller companies to ensure that product innovation is not hindered.
The American Association for Homecare sent a letter Sept. 12 to HHS Secretary Michael Leavitt and Centers for Medicare & Medicaid Services (CMS) Administrator Mark McClellan asking them to postpone implementation of a new coverage policy for power mobility devices (PMDs).