Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ciliatech, Neusoft.
The 50 million Europeans with peripheral artery disease have a new treatment option thanks to help restore blood flow to vessels below the knee now that Abbott Laboratories' Esprit BTK everolimus-eluting resorbable scaffold system has received CE mark. The stent, made of a material similar to dissolvable sutures, dissolves within three years.
A new entry in the peer-reviewed literature on Boston Scientific’s Agent drug-coated balloon seems to call into question whether in-stent restenosis should be treated with another stent, a discussion that could torque practice away from the stent-in-stent approach and toward the use of drug-coated balloons.
Rhovica Neuroimaging AG raised CHF 2.3 million (US$2.85 million) in a pre-seed financing round for Sonav, its bedside navigation system designed for extraventricular drainage. With its integrated sensors that provide real-time visualization to guide catheter insertion into brain ventricles, Sonav has the potential to transform emergency neurosurgery by improving safety and precision.
The U.S. Patent and Trademark Office has reacted to the Federal Circuit’s decision in Shockwave v. CLSI with a policy memo that draws tighter lines around the use of applicant admitted prior art in attempts to invalidate a patent during inter partes reviews.
The Medical Device Authority of Malaysia reported on Aug. 22 the piloting of a bilateral medical device approval program with Singapore to streamline the review and launch of medical devices in both countries.