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. Read More
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. Read More
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. Read More
Noninvasix Inc. received a breakthrough device designation from the FDA for its noninvasive Livox central venous oxygenation monitor, which allows real-time monitoring of central venous oxygen saturation (ScvO2) in patients at risk of septic shock. The Noninvasix optoacoustic platform consists of a disposable patient interface with a reusable probe, data display and hardware. Read More
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. Read More
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. Read More
John-Michael Havrilla, formerly the director of investor relations at Pavmed, has agreed to pay $160,000 in civil penalties over allegations he used inside knowledge of an impending earnings report to help himself to $80,000 in ill-gained profits, a sure sign the SEC is not ignoring med-tech firms in its pursuit of insider trading charges. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cdx Diagnostics, Cleveland Diagnostics, Symap Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Dyad Medical, Medtronic. Read More
