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An FDA draft guidance released last week provides recommendations on reporting data from studies of diagnostic tests and identifies common "inappropriate practices."
The time and expense required to get an FDA premarket approval (PMA) for a device may be worth it, as some devicemakers are finding themselves in court after taking the more streamlined 510(k) approval route, compliance lawyers say.
In recognition of the sometimes dizzying pace at which innovation is taking place in the medical device industry, the FDA announced last week that it was launching an initiative designed to approve devices more quickly by modernizing the development process.
Illinois company Hearing Health Express May 11 filed an appeal in the U.S. Court of Appeals for the Eighth Circuit against the Missouri Board of Examiners for Hearing Instrument Specialists, which has sought to prevent the company from selling hearing aids to Missouri residents “without the prior fitting or testing required by state law.”
Quebec-based medical device company ART Advanced Research Technologies has launched a Phase III clinical trial of its SoftScan breast imaging system at Toronto’s Princess Margaret Hospital.
Angioplasty with coronary drug-eluting stent therapy may be a viable alternative treatment to more complicated bypass surgery for patients with left main coronary artery (LMCA) disease, according to a new study conducted at Cedars-Sinai Medical Center.
The Merci Retriever, the only medical device cleared by the FDA to remove clots from the brain during an ischemic stroke, restored blood flow in nearly 70 percent of stroke patients, according to a new study.