MASSDEVICE ON CALL — Federal dollars may pay for STD tests on elderly. Centers for Medicare and Medicaid Services (CMS) officials are considering including tests for venereal diseases, such as syphilis and hepatitis B, in coverage for the elderly and disabled, according to Reuters.
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Plexus wins FDA clearance for hemorrhoid-prevention device | Regulatory roundup
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
Entellus wins FDA clearance for sinus endoscope | Regulatory roundup
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
Gore wins European approval for vascular graft | Regulatory roundup
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
ViewRay wins FDA 510(k) clearance for MRI-based radiotherapy technology
ViewRay Inc. received federal regulatory clearance to begin commercializing its MRI-based technology to deliver radiation therapy to cancer patients.
The Oakwood, Ohio-based company’s imaging device received clearance under the Food & Drug Administration’s 510(k) program for medical devices in January, according to the agency.
CEO Greg Ayres declined comment through a spokeswoman.
Shuren fires back on 510(k), Europe
Dr. Jeffrey Shuren, head of the Food & Drug Administration’s medical device arm, defended his agency’s performance before a U.S. House subcommittee today, rebutting a spate of recent criticism directed at the Center for Devices & Radiological Health.
Australia releases regulatory update for in vitro devices
By Stewart Eisenhart, Emergo Group
The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo application audits.
According to Australia’s Therapeutic Goods (Regulations) 2002, eight types of IVDs fall under the application audit requirements:
Medical device industry tees off
The medical device industry’s public relations campaign to push the regulatory agenda its way hit another level today, with industry advocates testifying before a U.S. House subcommittee, studies taking aim at the Food & Drug Administration and even an op-ed from a pair of friendly legislators.
A House Energy and Commerce panel, the subcommittee on health, is slated to hear about the “Impact of Medical Device Regulation on Jobs and Patients” today, led by chairman Rep. Joe Pitts (R-Pa.). Med-tech industry reps will likely find a sympathetic ear in Pitts.
FDA slaps Bioptigen with warning over marketing claims
Medical imaging technology company Bioptigen received a warning from the Food & Drug Administration alleging that the company is marketing its eye imaging scanner without proper approvals.
The Research Triangle Park, N.C.-based company makes a medical device that allows for imaging of the inner areas of the eye. The company has marketed the product for research as well as medical applications.
Covidien wins 510(k) clearance for small jaw surgical tool | Regulatory roundup
Covidien plc (NYSE:COV) won 510(k) clearance for a new "small jaw" cutting and sealing surgical instrument.
The clearance adds another device to the Mansfield, Mass.-based medical products maker’s 12-year-old LigaSure line of surgical tools.
Thermo Fisher wins FDA clearance for kidney-transplant test | Regulatory roundup
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.