The FDA granted 510(k) clearance to Sky Medical Technology Ltd.’s Geko device for patients with venous insufficiency and/or ischemia. The neurostimulation device is worn at the knee and increases blood flow in lower limb soft tissue of patients. The company said it will initiate a controlled market release in partnership with U.S. clinicians in a bid to reshape venous insufficiency treatment.

V-Wave Ltd. said on Dec. 17 that it has closed all remaining tranches of a $98 million extended series C financing led by Deerfield Management. The funds will be used to complete a pivotal IDE  trial for its Ventura interatrial shunt system for the treatment of advanced heart failure (HF) and submit a PMA to the FDA for U.S. marketing approval.

This year saw continued advances in smartwatches as they increasingly move from wellness assistants to medical monitors. Nowhere has that been clearer than in cardiovascular health, where multiple wearables now allow users to quickly detect atrial fibrillation, a notoriously shy condition previously only detectable in early stages by chance in a physician’s office or by wearing a cumbersome Holter monitor for 24 to 48 hours.

Royal Philips NV has signed an agreement to acquire Vesper Medical Inc., a U.S.-based developer of minimally invasive peripheral vascular devices. The deal expands Philips’s portfolio of technologies for the treatment of deep venous disease. The transaction is expected to be completed in the first quarter of 2022. Financial details were not disclosed.

Intervene Inc. received breakthrough device designation from the FDA for its treatment for chronic venous insufficiency (CVI), Blueleaf endovenous valve formation system, which makes new venous valves in the leg using the patient’s own vein tissue. The catheter-based system splits and stretches the vein wall to create a new leaflet. In a recently published study, 14 patients underwent the procedure, of which 13 successfully had at least one new valve created. No patients experienced adverse events during the procedure and no deep venous thromboses developed through a one-year follow up period.

Venus Medtech (Hangzhou) Inc. reported it has acquired 100% equity interest and corresponding equity in Cardiovalve Ltd. for $300 million. Or Yehuda, Israel-based Cardiovalve produces the Cardiovalve system, a transcatheter interventional replacement product for mitral or tricuspid regurgitation.

Stereotaxis Corp. reported positive results showing its robotic magnetic navigation (RMN) system significantly reduces the incidence of silent cerebral embolism (SCE) in patients undergoing atrial fibrillation (AF) ablation vs. hand-held catheters. The prospective, multicenter study is believed to be the first to compare AF ablation using RMN with manual control and to highlight the benefit in lowering SCE risk.

PARIS – Orixha SAS raised $2.25 million to bolster development of its Vent2cool medical device, pulmonary ventilation technology used in critical care settings. Investment company Erganeo SAS, the Angels Santé business angels group and three French industrial partners – Infiplast SAS, OEM Development SAS and Activation SAS – all participated in the round.

TORONTO – Opsens Inc. has successfully treated 20 patients in the first-in-human study employing a new surgical guidewire to improve procedural workflow during transcatheter aortic valve replacement (TAVR). According to Opsens CEO Louis Laflamme, the Savvywire will be the first guidewire to deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.

In the Dec. 3, 2021, issue of Science, researchers reported that a missense variant that is highly enriched in the Amish population was associated with reduced levels of both LDL cholesterol and fibrinogen. To date, very few variants have been identified that affect more than one risk factor for cardiovascular disease.