In what is claimed as the first co-authored research between regulatory scientists at the U.S. FDA and a commercial manufacturer of organ-on-a-chip devices, CN Bio's Physiomimix system is shown to perform better than the current standard in vitro liver toxicity tests.
A green light from the U.S. FDA has significantly brightened Seno Medical Instruments Inc.’s image of its immediate future. The San Antonio-based company developed a novel breast cancer imaging technology that combines noninvasive opto-acoustic (OA) technology with ultrasound (US) to more accurately distinguish benign from malignant breast lesions following ambiguous mammography results.
Vericiguat became the first oral soluble guanylate cyclase stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. But its commercial potential could be hampered by its modest clinical efficacy and increasing competition in the space, as well as difficulties launching a new drug during a pandemic.
In what is claimed as the first co-authored research between regulatory scientists at the U.S. FDA and a commercial manufacturer of organ-on-a-chip devices, CN Bio's Physiomimix system is shown to perform better than the current standard in vitro liver toxicity tests. In addition to maintaining its function for longer than 2D hepatocyte cultures or 3D spheroids, Physiomimix was found to reproducibly assess toxicity, metabolism and intracellular accumulation of drugs.
The U.S. Department of Health and Human Services (HHS) has awarded a contract for validation of lab-developed tests (LDTs) for the pandemic to a private company, a move that was apparently an effort to address the resource crunch at the U.S.
Johnson & Johnson has been looking to make a big splash in robotics. Now, its Depuy Synthes unit has made progress on this front, gaining U.S. FDA clearance for the Velys robotic-assisted solution designed for use with the Attune total knee system. The solution aims to help simplify surgeons’ existing workflow around total knee replacement.
The U.S. FDA notice regarding device risk classification proposes to eliminate premarket notification requirements for several device types, a welcome development for industry. However, Amanda Johnston, senior attorney at Gardner Law PLLC, of Stillwater, Minn., told BioWorld that there is a question regarding the provenance of the document, as it fails to identify any FDA staff member. In addition, the notice omits several device types that are solid candidates for down-classification.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. saw its shares rise 27% on the heels of its first U.S. approval for its collagen medical device for dental guided bone and soft tissue regeneration applications. “It’s an important milestone for us, and one that came quicker than I was expecting it to come,” Orthocell CEO Paul Anderson told BioWorld. The company submitted its 510(k) application to the FDA in May, and he was expecting approval by the middle of 2021.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS examines device classification process at FDA; NIH offers NGS system for SARS-CoV-2; FDA issues pandemic policy for coagulation systems.
Reports of multiple new variants of the SARS-CoV-2 virus have emerged, raising questions about the efficacy of vaccines, but also regarding the utility of diagnostic and other tests. The U.S. FDA’s Tim Stenzel said single-target tests are thus at a greater risk of returning a false negative result, adding that these developers “should consider this carefully” in surveillance of their tests.
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