PARIS – One year after inception, Lauxera Capital Partners SAS reported final closing of its Lauxera Growth I fund at nearly $300 million, making it the leading European fund devoted to financing health-tech businesses. Lauxera Capital’s objectives involve supporting fast-growing European firms and ramping their international business development.
The FDA has approved Medtronic plc’s next-generation sacral neuromodulation (SNM) system, Interstim X, giving patients a recharge-free option with a 10-year+ lifespan. This newest member of the Interstim portfolio joins the rechargeable Interstim Micro as a treatment for overactive bladder (OAB), chronic fecal incontinence (FI) and nonobstructive urinary retention.
Germany passed a law in 2019 that provides for a combined premarket review and coverage mechanism for lower-risk devices that provides a staged path for rate-setting with the help of real-world evidence (RWE). That model has caught the attention of other European Union member states, such as France, but may be useful in the U.S. as well, given the FDA’s policy moves for RWE and digital health over the past few years.
A neurostimulation device developed to treat focal epilepsy has received breakthrough device designation from the FDA. Precisis AG’s Easee [Epicranial Application of Stimulation Electrodes] minimally invasive system is designed to deliver individualized brain stimulation without neurosurgery. The electrode is placed subcutaneously on the cranium and a current is applied to the affected brain area to prevent or mitigate seizures.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Dyad Medical, Medtronic.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cdx Diagnostics, Cleveland Diagnostics, Symap Medical.
The U.S. SEC reported a settlement Feb. 23 with Baxter International Inc. and its former treasurer, Scott Bohaboy, and former assistant treasurer, Jeffrey Schaible, resolving charges involving years of improper intra-company foreign exchange transactions that resulted in the misstatement of Baxter’s net income.
PARIS – Companion Spine SAS has raised $55 million to help develop its noninvasive diagnostic and interventional implant solutions for the treatment of degenerative disc disease and lumbar spinal stenosis. This series A round was led by Viscogliosi Brothers LLC, a New York-based investment company specializing in financing disruptive technology in spine treatment.
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