A study published in Human Reproduction showed no developmental delays in children conceived using capacitation-in vitro maturation (CAPA-IVM) technique developed by Lavima Fertility Inc. compared to those born through conventional in vitro fertilization (IVF). Researchers presented the results at a July 6 session of the European Society of Human Reproduction and Embryology in Milan, Italy.
Oxford University has opened the doors to its new Pandemic Sciences Institute, a £100 million (US$119.5 million) initiative to build on the research and experience of COVID-19, to counter future pandemic threats.
A French public-private consortium of seven med-tech companies, research institutes and specialist cancer hospitals is launching a new project to standardize and improve access to health care data for cancer research. Paris-based Arkhn SAS and Owkin SAS joined forces with INRIA, the French national institute for research in digital science and technology, to launch Oncolab.
Companies in the device and diagnostics spaces are familiar with how government agencies react to acquisitions that bolster the acquiring company’s product pipeline, but vertical mergers provoke a different set of regulatory concerns. The European Commission (EC) recently updated its guidelines for vertical agreements, a development that could hamper some EU corporate activity going forward.
Envision Technologies BV’s latest artificial intelligence (AI)-powered smart glasses for the blind and visually impaired are designed to help with reading, scanning faces and navigating everyday tasks. This visual assistant was introduced at California State University Northridge (CSUN) 2022 Assistive Technology Conference. Envision has updated its AI-based platform and ecosystem with improved optical character recognition (OCR) and better text recognition with contextual intelligence.
If GE Healthcare’s GM of Monitoring Solutions Neal Sandy gets his way, nursing staff will perk up and notice a newly launched wireless patient monitoring system that helps them detect patient deterioration much earlier than periodic, manual monitoring.
In an era of ever-increasing change in regulation of medical devices, the 2021 draft regulatory proposal by the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) might have seemed like an invitation to regulatory balkanization. However, MHRA said the responses to the draft proposal indicated widespread support for “international collaboration with like-minded regulators,” thus reassuring industry that their developmental devices won’t face an entirely new set of barriers to access to a market of more than 67 million.
Humacyte Inc. provided its Human Acellular Vessel (HAV) implants to Ukrainian hospitals on the front-line of the Russian invasion as part of the company’s humanitarian relief initiative. Two patients have received the implants for treatment of vascular trauma injuries. One patient had sustained a severe gunshot wound to the leg and the other was injured by shrapnel.
Biocartis Group NV received CE-marking of its Idylla Gene Fusion lung cancer biomarker test. The automated panel is designed to detect chromosomal translocations that generate fusion genes and cause non-small-lung cancer (NSCLC). Mechelen, Belgium-based diagnostics company Biocartis recently reported results from a study that found the assay enables rapid screening with quicker turnaround and lower tissue requirements compared to standard methods.
Los Angeles-based cancer diagnostics company Nonagen Bioscience Corp. obtained CE marking for its Oncuria immunoassay for bladder cancer. The multiplex urine test is designed to detect the concentration of 10 proteins that are associated with bladder cancer in urine samples. Clinical studies found the test has a 93% sensitivity and 93% specificity for detecting bladder cancer. The test is also designed to predict whether people are more likely to respond to bacillus Calmette-Guérin (BCG) therapy, a first-line treatment for bladder cancer.
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