The FDA's September 2019 final guidance for the humanitarian device exemption program brought some clarity to several issues, but device makers must still untangle the question of which tasks an institutional review board (IRB) has delegated to an appropriate local committee for a specific clinical site.

The U.S. FDA has given 510(k) clearance to the Advanced Intelligent Clear-IQ Engine (AiCE) for Canon Medical Systems USA Inc.'s Aquilion Precision CT scanner. The regulatory green light brings artificial intelligence (AI)-based image reconstruction capabilities to the world's first ultra-high resolution CT imaging system.

Researchers at the Abramson Cancer Center at the University of Pennsylvania have developed an algorithm to better personalize immunotherapy treatment. The algorithm works by examining neoantigen quality, not just their quantity. Neoantigens are proteins that are the result of genetic mutations in a tumor.

The FDA has granted 510(k) clearance to the first hernia mesh featuring a nanometer-level surface texture, enabling better post-implant tissue ingrowth and reducing the incidence of adverse reactions. The Exogenesis Hernia Mesh, by Billerica, Mass.-based Exogenesis Corp., is indicated for the repair of abdominal wall hernias and deficiencies that require reinforcement to stabilize the condition and achieve a positive surgical outcome. The company expects to launch the product nationwide in 2020.

HONG KONG – South Korean biomarker-based molecular diagnostic firm Genomictree Inc. has built a U.S. unit in Pasadena, Calif., with an investment of KRW12 billion (US$10 million). The Daejeon, South Korean-based company first disclosed its plan to build the U.S. branch in March.

Lisle, Ill.-based Endotronix Inc. scooped up $70 million in an expanded series D funding round led by Life Science Partners. The funds will support the company's PROACTIVE-HF IDE clinical trial of the Cordella Pulmonary Artery Sensor System and further commercialization of the Cordella Heart Failure (HF) System.

Sterigenics US LLC, of Oak Brook, Ill., has announced it will not reopen its ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., a development that could strain the capacity for sterilization of devices such as duodenoscopes. Illinois is not the only state that is taking action on EtO, however, a predicament that suggests the U.S. federal government may have to insert itself into the discussion in order to avoid a shortage of critical, life-saving devices.

Functional Neuromodulation Ltd. is looking to help those suffering from mild Alzheimer's disease. To that end, it recently disclosed that it has kicked off the global ADvance II Study (NCT03622905), a pivotal clinical trial to assess deep brain stimulation (DBS) in these patients.

The U.S. FDA's emphasis on device safety is well known. Now, the agency has published a draft guidance that aims to provide expedited reviews for device and diagnostic applications that are "reasonably expected to significantly improve" safety, which, in conjunction with the breakthrough devices program, suggests that many other applications will be in the queue for increasingly longer periods of time.