Integra Lifesciences Holdings Corp. will not launch any new product in the EU before the U.S. because of the challenging requirements under the new Medical Device Regulation, Stuart Hart, chief medical officer at the Princeton, New Jersey-based company, told delegates at the LSX conference in London.
In what represents just the third PCT filing to have been published in the name of Zurich, Switzerland-based Siva Health AG, protection is sought for a computer-implemented method of classifying an individual suffering from chronic cough.
Front Line Medical Technologies Inc. recently received CE mark for its Cobra-OS, the smallest REBOA (resuscitative endovascular balloon occlusion of the aorta) device for use in emergency situations on the market. The company believes that Cobra-OS could help save the lives of patients during traumatic bleeding situations as it could buy valuable time until definitive care can be provided.
Owlstone Medical Ltd. received $6.5 million in funding from the Bill & Melinda Gates Foundation which will go towards expanding its Breath Biopsy platform as well as developing breath-based diagnostic tests to identify breath biomarkers for tuberculosis and HIV.
The EU has declared that it will investigate the anticompetitive practices of the People’s Republic of China where medical devices are concerned, a clear sign that device makers in the European Union succeeded in persuading Brussels that the Made in China 2025 initiative represents an intolerable form of economic adversarialism.
Researchers have developed and validated a new technique that allows them to measure the lipid compounds in live cancer cells, one by one, according to a study published in the journal Analytical Chemistry. The new method paves the way for analyzing cells in greater detail to better understand infection, immunity and other phenomena, and could lead to the development of new, more targeted treatments.
Smart Reporting GmbH raised €23 million (US$24.5 million) in a series C funding round for its medical reporting software which automates and streamlines physicians’ workload. The funding is a “significant accelerator” for the company, “catalyzing business growth, product development, and expansion into international markets,” Wieland Sommer, founder and co-CEO of Smart Reporting told BioWorld.
The Netherlands-based research company Stichting imec Nederland filed for protection of a smart toilet seat for the non-invasive measurement of physiological parameters, and especially for detecting a bowel movement and/or urination, and for characterizing excrement or feces in terms of a firmness level.
Researchers from the U.K. reported seeking protection for a device and method that combines electromyography (EMG) and Raman spectroscopy to improve the diagnostic pathway for patients with neuromuscular disorders, and that may be used as a minimally invasive bedside test of muscle health.
Reliance may be the regulatory buzzword of the moment, but mutual recognition agreements between regulators are much more near and dear to the hearts of device makers. Richard Phillips, director of strategy for Association of British Health Tech Industries Ltd., told an audience of device makers that the U.K. is considering recognition of devices approved and cleared by the FDA, although Phillips said such recognition for 510(k) devices might be less than a simple exercise.