The FDA’s Center for Devices and Radiological Health (CDRH) has released its ombudsman report for 2011, the first year the office’s electronic tracking system has been used to facilitate record-keeping and trending.

The FDA has granted clearances for GE Healthcare's Brivo NM615, a single-head nuclear medicine gamma camera with SPECT capability.

The FDA has issued draft guidance to clarify current review practices of premarket notification 510(k) submissions for FDA staff and manufacturers of medical devices.

The FDA has sent a warning letter to International Isotopes, a radiochemical product manufacturer based in Idaho Falls, Idaho, due to violations of Current Good Manufacturing Practice regulations.

The International Contrast Ultrasound Society (ICUS) has applauded the FDA’s decision to modify the U.S. product label for Definity Injectable Suspension, an ultrasound contrast agent. 

The FDA’s MedWatch program, established in 1993, allows physicians, nurses or patients to report an adverse event associated with an approved device or drug. Not only does the program evaluate and generate information based on the reports, but it also makes that information available to providers, manufacturers and the public, explained Brenda J. Rose, pharmaceutical director, Office of Special Health Issues, FDA, during an Oct. 20 FDA webinar.

A proposed guidance document from the Global Harmonization Task Force (GHTF) recommends standardizing conformity assessments for four medical device classes. The recommendations take into account the relative potential of each class to cause user or patient harm.

The FDA is seeking public comment on eight draft proposals aimed at increasing access to compliance and enforcement data. The proposals were made in compliance with President Barack Obama’s Memorandum on Regulatory Compliance, which requires federal agencies to make publicly available compliance information easily accessible, downloadable and searchable online.

Infinitt North America, a developer of image and information management technologies for healthcare, has received FDA clearance for its fusion software, Xelis Fusion. The software is now available to the North American market.

The FDA has released draft guidance clarifying when device modifications trigger the need for a new premarket review, or 510(k) submission. When finalized, it will supersede the previous 1997 guidance on the subject.

NeuroLogica has received CE Mark approval for its portable inSPira HD SPECT camera.

In releasing draft guidance on premarket approval applications for medical devices earlier this week, the FDA stated it will accept public comment on the draft until Nov. 14.

The recently released FDA guidance on current good manufacturing practice (cGMP) for PET drugs addresses resources, procedures and documentation expected of facilities, as well as distinguishes between PET drug production practice and pharmacy practice.

Neoprobe, a developer of oncology surgical and diagnostic products, has submitted a new drug application for Lymphoseek (tilmanocept) to the FDA.

Siemens Canada Healthcare has received a Health Canada medical device license for the Biograph mMR, a whole-body molecular MR with simultaneous MR and PET data acquisition.

The FDA released a draft guidance defining in vitro (IVD) companion diagnostic devices and explaining the review and approval standards for related products. Additionally, the guidance clarifies instances when IVD companion diagnostic devices or therapeutic products may be approved singularly, as well as labeling requirements.

In an effort to reduce regulatory burden for in vitro diagnostic and radiology devices, the FDA stated its intent to exempt a number of devices from certain premarket regulatory requirements.

Intended to improve the usability of medical devices, as well as reduce errors, injuries and product recalls, the FDA issued a draft guidance June 22 for conducting tests to see how humans interact with technology.

As part of a new strategy to keep up with imported regulated products, the FDA said it will work with international regulatory bodies to foster safe product development globally. The agency said the strategy, titled “Pathway to Global Product Safety and Quality,” includes developing international data information systems and networks to share regulatory resources across world markets.

Specialty pharmaceutical company Acusphere has reached an agreement with the FDA on a Special Protocol Assessment clinical trial to assess the ability of the company’s Imagify drug to detect coronary artery disease (CAD) on stress ultrasound.