Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerin Medical, Blackswan Vascular, Cytovale, Elucid, Nanovibronix, Neovasc, Sirtex Medical.
Keeping you up to date on recent developments in cardiology, including: PCI still the treatment of choice for COVID-positive STEMI patients; Utility of risk scores for TAVR patients questioned; Plaque similarly predictive in women and men.
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
Koelis SAS reported the first successful procedures for its platform in 3D fusion imaging-guided focal ablation of prostate cancer at the Clinique Nantes Atlantis in Saint-Herblain, France. These first procedures take place against the background of a multicenter prospective clinical trial starting on the Koelis platform. This includes eight European urology centers, of which six are in France, with data being stored in a dedicated registry.
The FDA has finalized a 2018 draft rule that excludes several digital products from the definition of a medical device, a list that includes medical device data systems (MDDS) used in hospitals. The rule responds to requirements spelled out in the 21st Century Cures Act, which was signed into law in late 2016, making this a project of nearly five years’ duration on the FDA’s part.
Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients.
Lumicks BV raised $93 million in a series D financing led by new investors Farallon Capital Management and Lauxera Capital Partners. The proceeds are earmarked for expansion of the Lumicks’ product pipeline and for commercialization of its Z-Movi cell avidity analyzer.
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