Johnson & Johnson launched its latest pulsed field ablation (PFA) catheter, Varipulse Pro, in Europe following CE mark approval, bringing another option to electrophysiologists looking to adopt PFA technology. The system features a new pulse sequence with a lower temperature profile and enables ablation that is five times faster than the previous sequence, while achieving equivalent lesions. It represents another significant development in the rapidly evolving PFA market that has transformed cardiac ablation treatment.
With CE-marked products accounting for about 90% of medical devices currently used in Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) is considering proposals for a path forward that would help the U.K. achieve its goal of becoming a leading country for med-tech access by 2030.
Highlife SAS secured CE mark for its transcatheter mitral valve replacement (TMVR) system, bringing a much needed treatment option for patients with limited alternatives. The Highlife TMVR system is indicated for individuals with symptomatic moderate-severe or severe mitral valve regurgitation who are unsuitable for surgical repair or replacement and transcatheter edge-to-edge repair.
Boston Scientific Corp.’s intent to acquire Penumbra Inc. for $14.5 billion will not only allow it to expand its minimal invasive care portfolio in areas such as embolization and peripheral vascular disease, but to also reenter the neurovascular space, Kathleen Van Vlierberghe, vice president of Peripheral Interventions EMEA, told BioWorld.
Roche AG received regulatory clearance from the U.S. and European authorities for a new diagnostic test that detects Bordetella infections, including whooping cough, as cases surge globally. The point-of-care test, which delivers PCR-accurate results in just 15 minutes, will help health care providers to quickly identify infections and act to prevent severe complications, onward transmission and deaths.
Overture Life SLU secured CE mark certification for its Davitri system that automates the vitrification and thawing of oocytes and embryos, making the processes more efficient, consistent and cost-efficient. Davitri has the potential to transform IVF, giving women and families more control over their fertility timelines and ensuring every egg and embryo has the best possible chance of survival.
Roche Holdings AG received CE mark approval for its Elecsys Dengue Ag test, a fully automated, high-throughput immunoassay to help diagnose acute dengue virus infections. With cases of dengue on the rise worldwide, the test, which delivers results in 18 minutes, offers high sensitivity and specificity across all four dengue virus serotypes, and will help clinicians confidently distinguish dengue from other illnesses causing acute fever.
Rhythm Diagnostic Systems SAS (RDS) raised €14 million (US$16.6 million) in a series A funding round for Multisense, its wearable device that continuously monitors key physiological parameters of patients in hospital or at home. Already CE-marked and deployed in approximately 15 hospitals across France, Belgium and Germany, the funds will enable RDS to expand its commercial and customer support teams and prepare reimbursement filings in key European markets, Elie Lobel, CEO of RDS, told >BioWorld.
Kent Imaging Inc. received CE marking for its SnapshotNIR imaging device which uses near-infrared spectroscopy to measure oxygenated and deoxygenated hemoglobin in the microvasculature. The non-invasive point-of-care device provides real-time data to clinicians to help them make decisions which can change the trajectory of a wound, from chronic and non-healing, into a healing one, significantly improving the patient’s quality of life.
Convatec Group plc secured CE mark and UKCA approvals for Convamatrix, its porcine placenta-based wound dressing designed for hard-to-heal wounds. The single use, skin substitute product is intended to cover, protect and provide a moist wound environment to support the body’s natural healing process.
