The comment period has closed on the Environmental Protection Agency’s draft rule for ethylene oxide (EtO) used in device sterilization, and the docket is littered with pushback from industry on several points. Ruey Dempsey of the Advanced Medical Technology Association argued a fundamental methodological point in her comments to the docket, stating that the EPA approach to determining safe levels of EtO relies on “a single epidemiological study.” Dempsey also said the National Academies of Science (NAS) has expressed reservations about such an approach, and called on EPA to consult with NAS regarding that 2016 EPA assessment.
PERTH, Australia – Brisbane-based Field Orthopaedics was formed when a group of orthopedic surgeons were frustrated by ongoing shortcomings in surgical practice and decided to do something about it. Orthopedic surgeons Chris Jeffery, Greg Couzens and Libby Anderson were frustrated by the longstanding shortcomings in devices for extremity surgery, “because 40% of the time there is a complication or suboptimal outcome with an extremity operation secondary to the devices,” Field Orthopaedics CEO Chris Jeffery told BioWorld.
Alydia Health, of Menlo Park, Calif., has completed enrollment in the pivotal PEARLE investigational device exemption study, which is assessing the safety and effectiveness of the Jada System to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage. Anne Morrissey, Alydia’s CEO, explained to BioWorld that abnormal bleeding following childbirth affects 10% of mothers. “In the U.S., we have a high rate of complications from childbirth requiring treatment including hysterectomies and other invasive procedures, and a high rate of blood transfusions (up to 2%), which can have real short- and long-term impacts on a new mom,” she added. “We can do better for our mothers.”
LONDON – Surgeons in the Netherlands have carried out what is claimed as the first human supermicrosurgery, connecting vessels of a diameter as low as 0.3 mm using a purpose-designed robotic system. Although microscopes and instruments are available to carry out surgery on vessels ranging from 0.3 mm – 0.8 mm, performance is constrained by the precision and dexterity of human hands. Now, researchers have reported the first procedure with MUSA, a robotic system designed to stabilize the hand movements of surgeons by filtering out tremors and scaling down motion.
BEIJING – Researchers from The Hong Kong Polytechnic University have developed a diagnostic system that they claim is the world’s most comprehensive as it can identify 30 to 40 pathogens in one single test within an hour. The automated multiplex diagnostic system comes with a fully automated machine and a multiplex full-screening panel for point-of-care genetic testing (POCT) of respiratory infectious diseases, including COVID-19, which has infected nearly 60,000 people and killed over 1,300 as of Feb 13.
The articles from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak are available at www.bioworld.com/coronavirus. The collection includes breaking research, clinical, regulatory and business development news on coronaviruses reaching back to 1991. Featured topics: vaccines and diagnostics in development, the science underpinning the virus, comparison to previous outbreaks such as Severe acute respiratory syndrome (SARS) and Middle Eastern respiratory syndrome coronavirus (MERS-CoV), global regulatory factors and the business news underpinning the research including development collaborations and investment trends.
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