Cvaid Medical Ltd. secured $4 million in a series A financing to further develop its mobile stroke diagnostic, monitoring and treatment platform. The Israeli Rad Biomed investment fund led the round with participation from Philips Ventures and Sanara Capital. As part of the financing, a representative from Philips will join the board. The smartphone-based system, Cvaid uses artificial intelligence to process and analyze video and voice recordings to identify and assess the severity of patients experiencing stroke, also called cerebrovascular accidents. Read More
LONDON – The European Commission (EC) has put forward proposals for a Data Act that is intended to both give users greater rights over their own data and allow greater third-party access. The Act sets out who can use and access data generated in the EU across all sectors of the economy. It is pitched by the EC as opening the doors to an under-used resource that will in turn promote research and innovation and create new markets in information services. Read More
A Seattle-based startup has secured breakthrough device designation for its blood-based Alzheimer’s disease (AD) test. Altpep Corp.’s Soba-AD platform is designed to selectively detect toxic forms of amyloid-beta peptide associated with AD progression. The company said early data indicated the assay can detect AD before symptoms including cognitive impairment and neurodegeneration arise. Read More
The FDA’s proposal to harmonize the Quality System Regulation (QSR) with ISO 13485 has finally become more than just a hot topic among device makers, and the agency held a March 2 advisory hearing on the matter. One of the critical concerns for industry is the proposal of a one-year term of implementation upon publication of a final harmonization rule, a timeline that some argue should be doubled or tripled in order to serve as a practicable implementation timeline. Read More
Differential leg length is perhaps not the most common orthopedic problem in the medical literature, but the U.K. National Institute of Health and Care Excellence (NICE) sees a place for some sort of improvement over the standard of care. Read More
New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biointellisense, Bio Lab, Biotrust, Curevac, Eli Lilly, Empyrean Medical, GC Labs, Green Cross, Heartbeam, Neptune, Quanterix, Second Genome, Sensus Healthcare, Verso Biosense. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Gleamer, Intrivo, J&J Vision, Valencia Technologies. Read More
