Devices & Diagnostics Letter

Joshua Sharfstein has stepped down as the FDA’s principal deputy commissioner, the agency’s No. 2 post, to head the Maryland Department of Health and Mental Hygiene.

Indefinite waits for major guidances may become a thing of the past if the FDA develops timelines for producing the documents.

Sponsors of device trials will have until March 7, 2012, to modify their informed consent forms following a new rule from the FDA.

Devicemakers will face some hurdles in getting innovative technologies to market over the next decade, CDRH says in a 10-year forecast that anticipates advances in a number of device areas.

CDRH has launched a database to make information about postapproval device studies more accessible.

AdvaMed spent more than $358,000 lobbying the federal government in the third quarter of 2010, much of which went to fight efforts to overturn device preemption and push for caution in the 510(k) reform process.

Despite professional guidelines, years of clinical practice and industry comments, the Centers for Medicare & Medicaid Services (CMS) is sticking to its decision to deny coverage of home-use oxygen for cluster headaches.

The impact of a global diagnostic isotope shortage last year is still reverberating throughout the device industry as healthcare providers continue to use the alternative imaging methods they were forced to adopt to deal with the prolonged technetium-99m (Tc-99m) shortage.

Nearly 25 percent of patients who receive implantable cardioverter-defibrillators (ICDs) for primary prevention don’t meet the evidence-based criteria, a new study published in the Journal of the American Medical Association (JAMA) says.

Makers of in vitro diagnostics (IVD) for Lyme disease should conduct cross-reactivity studies to establish the performance of their devices in detecting antibodies to Borrelia burgdorferi, the FDA advises in a new draft guidance.

Sponsors of nucleic acid-based in vitro diagnostics (IVDs) intended to detect Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) should indicate the cutoff values for all outputs of the assay, including the cutoff value for defining negative and positive results, according to a new draft guidance.

Boston Scientific has completed the $1.5 billion sale of its neurovascular business to Stryker.

As the number of Americans with multiple chronic conditions increases, device sponsors may be asked to expand their clinical trials to include more subjects with two or more health problems.