Shanghai Microport Medbot (Group) Co. Ltd. started trading its shares on the Hong Kong Stock Exchange on Nov. 2, with shares increasing over 6% in the middle of the day. It raised HK$1.56 billion ($201 million) with shares going at HK$43.2 apiece in an initial public offering. The firm plans to use 35% of the proceeds for the development and commercialization of its core product, the laparoscopic surgical robot Toumai. Read More
As a counterpoint to the raft of wellness-promoting smartwatches, Purdue University and Physiq Inc. have developed a smartwatch algorithm that flags illness. A year after launching their co-development program, the two organizations reported they have created an algorithm designed for smartwatches that enables detection of early signs of infection. The algorithm is already in use in a number of Physiq’s customers’ applications, Physiq Chief Scientific Officer Stephan Wegerich told BioWorld. Read More
The FDA convened a Nov. 2 advisory panel to review the data for the AFX2 by Endologix LLC, of Irvine, Calif., with some indication that the agency believes the data suggest a poor benefit-risk ratio when used in treatment of abdominal aortic aneurysms (AAAs). The panel concluded that the benefits of the device do outweigh the risks for some patients, although the applicable patient population is likely to be smaller than is currently seen in clinical practice. Read More
Astrazeneca plc has signed an agreement with liquid biopsy testing company Saga Diagnostics AB to develop dPCR assays. Lund, Sweden-based Saga Diagnostics will develop Sagasafe dPCR assays towards undisclosed methylated targets for analysis of tissue samples and liquid biopsies. The assay is part of Saga’s portfolio of “ultrasensitive technologies,” comprising Sagasign for personalized monitoring of cancer burden and minimal residual disease. Read More
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) is inviting manufacturers to submit electronic cigarettes for approval as medical devices, after drawing up new guidance on the standards that will be required for approval. The move means the U.K. could become the first country in the world where e-cigarettes are available on prescription as smoking cessation aids. Read More
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued an advisory regarding the risk of anaplastic large cell lymphoma (ALCL) in association with breast implants, but stopped short of recommending explant for asymptomatic patients. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Argon Medical Devices, Hyperfine, Infusystem, Kaia Health, Luna. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Magstim, Orasure, Perimeter Medical Imagining AI, Transit Scientific, Vuno. Read More
