Abbott Laboratories has received CE mark approval for its Tendyne transcatheter mitral valve implantation (TMVI) system, the first such device approved for use in Europe and the world. The system is intended for patients with leaky mitral valves that are beyond repair and those at high risk for open heart surgery. Read More
BEIJING – Chinese regulators are speeding up to approve more test kits for the deadly coronavirus that already has killed 170 people and infected more than 7,700 globally. Companies also are working around the clock to develop better products and maintain supplies. Read More
The World Health Organization (WHO) has declared a "public health emergency of international concern" over the global outbreak of novel coronavirus (2019-nCoV), reversing a week-ago decision by its International Health Regulations Emergency Committee. The move comes "not because of what is happening in China, but because of what is happening in other countries," said WHO Director General Tedros Adhanom Ghebreyesus, noting his confidence in China’s capacity to control the outbreak. "Our greatest concern is the potential for the virus to spread to countries with weaker health systems, and which are ill-prepared to deal with it," he said. Read More
Early detection of neurodegenerative disease even before symptoms emerge is the ideal when it comes to trying to treat or prevent progression. But that has remained difficult, as brain tissue that isn’t available until after death is typically the most definitive. Now, researchers have used an artificial intelligence (AI) algorithm to identify genetic expression data over time and correlate them in blood and postmortem brain tissue samples from subjects with either Alzheimer’s or Huntington’s disease. Read More
TORONTO – Calgary, Alberta-based Orpyx Medical Technologies Inc. has launched a sensory insole with remote patient monitoring to prevent potentially fatal diabetic foot ulcers (DFU) and neuropathy-related ulcers. According to Orpyx CEO Breanne Everett, development of the Orpyx SI sensory insole system follows years of study on how DFUs occur and how best to share information with patients and doctors so they can react quickly to first signs of the condition. Read More
The U.S. FDA’s emphasis on internationalized regulations continues with the agency’s adoption of ISO 14971, the risk management framework published by the International Organization for Standardization (ISO). The FDA said it will accept declarations of conformity to the previous edition until December 2022, giving device makers roughly three years to update their systems. Read More
PARIS – White Fund SA, of Lièges, Belgium, secured $22 million for early stage financing of Belgian med-tech companies. “Our shareholders are investing in a specialized fund [that], beyond financial returns, [creates] expectations in terms of supporting the strong med-tech ecosystem in Belgium and advantages in terms of job creation,” explained Benoît Fellin, investment manager at Noshaq SA, manager of the White Fund. Read More
Med-tech firms raising money in public or private financings, including: Emboline, Establishment Lab Holdings, Lyra Therapeutics, MRI Interventions Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Genetesis, Profusa, Righteye, Venturemed Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcam, Applied Stemcell, Best Medical International, Bgi, Biofourmis, Conmed, Curetis, Fuzionaire Diagnostics, Healthfirst, Hollister, ImagineMIC, Microsoft, Nationshearing, Transenterix Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Bionik, Medtronic, Sony Read More
Keeping you up to date on recent developments in diagnostics, including: Increasing early disease detection; Adapting NGS for coronavirus surveillance; AD and HHV: Still a mystery; Increasing accuracy of malaria diagnoses Read More
