LONDON – Nyxoah SA reported positive clinical results for Genio, its lead-free, battery-less implantable neurostimulation device, showing it resulted in a significant reduction of the severity of obstructive sleep apnea (OSA), the world's most common sleeping disorder.
Navidea Biopharmaceuticals Inc. disclosed positive results from the first interim analysis of its ongoing NAV3-31 phase IIb study. Analysis shows the data support Navidea's hypothesis that Tc 99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA).
TORONTO – Winnipeg, Manitoba-based Medicure Inc. said results of a study released last week could nudge the door open wider in the U.S. for a device adapted from the military to normalize lung fluid content in patients suffering from heart failure.
PARIS – Clinatec Research Center, of Grenoble, France, is heralding the publication of results from its Brain Computer Interface (BCI) Exoskeleton clinical trial in the journal Lancet Neurology. Its semi-invasive medical device, Wimagine, has enabled a quadriplegic patient to move by transmitting signals emitted by his brain to an exoskeleton. This is the first proof of concept for control of a four-limb exoskeleton by a neuroprosthesis.
Polarityte Inc., of Salt Lake City, reported positive results from a pilot study of its Skinte regenerative skin product in the closure of venous stasis leg ulcers (VLUs) after standard treatments have failed. The findings were reported at the Symposium on Advanced Wound Care fall meeting, Oct. 12-14, in Las Vegas.
Synthetic biology is seeing rapid advances, but the medical applications have thus far remained largely elusive. But now researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University and Harvard Medical School (HMS) have developed a tool that can track specific populations of bacteria in the gut of living organisms and document population changes over time.
San Clemente, Calif.-based Glaukos Corp. has finished enrolling patients in its U.S. investigational device exemption (IDE) trial for the Istent Infinite trabecular micro-bypass system, which is intended for standalone use in lowering intraocular pressure (IOP) in refractory glaucoma patients. If all goes as planned, the company is looking to commercially launch the treatment in the U.S. in 2021.
LONDON – There is no evidence for increased mortality in patients receiving paclitaxel-eluting stents and drug-coated balloons (DCBs) to treat peripheral arterial disease, according to the largest real-world safety analysis to date. The findings may come as a relief to many, particularly after a meta-analysis published in December 2018 led to safety warnings and restrictions on the use of coated and drug-eluting devices.
The routine application of medical device technology to neurological indications beyond pain remains challenging in all but the most severe patients. Micro-cap Neuronetics Inc. is aiming to change all that with its Neurostar transcranial magnetic stimulation (TMS) system that is noninvasive and used in the physician's office.