Cytovale Inc., a San Francisco-based medical technology company, has picked up $15 million in financing to advance its technology that enables the early detection of sepsis in the emergency department. Specifically, the company raised $7.4 million in an extension of series B equity financing, co-led by existing investors Breakout Ventures and Blackhorn Ventures. Western Technology Investment also participated, providing a venture debt facility to the company. Read More
The U.S. FDA's overhaul of the 510(k) program continues apace with the recent final guidance for the special 510(k) mechanism. However, a member of the FDA staff said clerical errors account for a conspicuous number of conversions of these applications to traditional 510(k)s than any other problem. The agency posted the final guidance for the special 510(k) program in September with features seen in the draft that drew opposition from device makers. Read More
HONG KONG – Indonesian regulators have introduced a medical device risk classification system, as part of a harmonization of regulations across the Association of Southeast Asian Nations (ASEAN) region. The 'Sistem Klasifikasi Risiko Alat Kesehatan' system, known by the acronym Siklara, takes its cues from the ASEAN Medical Device Directive (AMDD). Read More
PARIS – Myriade SAS reported the commercial launch of its Videodrop technology at the second congress of the French Society of Extracellular Vesicles (FSEV) held in October in Nantes. This new nanoscale imaging technique captures all nanoparticles ranging from 30 nm to 10 μm in a droplet of solution (5-10μl volume), without initial data labeling. Read More
A Chinese study has identified small-molecule compounds that can selectively reduce levels of the mutant Huntingtin (HTT) protein involved in the pathogenesis of Huntington's disease (HD), and possibly other neurodegenerative diseases involving mutant protein accumulation. Read More
