It’s no surprise to hear that industry’s view of a device’s inherent risk differs from that of the U.S. FDA, a disparity that came to surface in a new citizen petition from Metaltronica SpA of Pomezia, Italy. The company petitioned the agency to down-classify digital breast tomosynthesis system to class II, a move that would align the risk classification with full-field digital mammography and ease the premarket path for future digital breast tomosynthesis applications.

In a May 8 Senate hearing, U.S. FDA commissioner Bob Califf described the agency’s advisory committee process as a useful source of information, but Califf reassured members of the Senate that the FDA is not intent in doing away with advisory hearing votes altogether.

This time a positive result for a cancer screening test brought good news, as Geneoscopy Inc. secured U.S. FDA approval for its RNA screening test for colorectal cancer. The agency based its decision on strong results from the phase III CRC-PREVENT trial in its approval of the noninvasive test for use in individuals aged 45 years and older with average risk for the disease.

Researchers from the University of Pittsburgh have developed a device designed to collect exhaled respiratory aerosols from mechanically ventilated patients. Their device is designed to be non-invasive, highly efficient and can be readily placed in the exhalation line of ventilators without interfering in the functions of the ventilator.

Angle plc recently signed an agreement with Astrazeneca plc to develop an androgen receptor (AR) detection assay for use in prostate cancer studies, based on its Parsortix system, which captures and harvest circulating tumor cells for subsequent analysis.

Heartflow Inc. reported exceptional results in a study published in the Journal of Vascular Surgery that revealed coronary computed tomography angiography with fractional flow reserve care reduced mortality by more than 60% at five years in patients with peripheral arterial disease undergoing major vascular surgery, far surpassing the current standard of care.

The U.S. FDA and industry have been in scramble mode for some time to address the Environmental Protection Agency’s actions on ethylene oxide, but some manufacturers must also deal with other regulators’ perceptions of what constitutes an acceptable method of sterilization.

Researchers have developed a new blood collection device inspired by the behavior of a leech which attaches itself to a host, penetrates their skin with its teeth and swallows to create negative pressure drawing blood.

Mexico’s Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has released a draft proposal that would overhaul the 2008 version of the rule for device labeling, a document that includes several key proposed reforms.