Wallaby Medical announced yesterday that it won FDA 510(k) clearance and CE Mark approval in the European Union for its Avenir coil system for intracranial aneurysms and other neurovascular abnormalities. The Laguna Hills, Calif.-based company also said it inked an exclusive distribution deal with Phenox for the commercialization of Avenir in the U.S. and Europe. […]
BioSig’s NeuroClear Technologies raises nearly $4m
BioSig Technologies (NSDQ:BSGM) said last week that its subsidiary, NeuroClear Technologies, raised nearly $4 million in an initial seed-funding round. NeuroClear said it intends to use the proceeds from the $3.7 million round to fund product development and initial pre-clinical studies, development of its intellectual property portfolio and for general corporate purposes. Founded in November 2018, […]
Nihon Kohden launches EEG device
Nihon Kohden (TYO:6849) today said it launched its VitalEEG wireless electroencephalogram headset in the U.S. The EEG system quickly evaluates brain-wave information of unconscious patients. It is designed for quick setup and efficient placement of electrodes within five minutes to allow clinicians to quickly assess brain health and determine the best treatment options for unconscious patients, […]
Integra LifeSciences buys Rebound Therapeutics
Integra LifeSciences (NSDQ:IART) said today that it has acquired Rebound Therapeutics, maker of a single-use, minimally invasive neurosurgery device. Financial terms of the deal were not disclosed. Rebound touts its Aurora Surgiscope system, — cleared by FDA in January — as the first single-use disposable neurosurgical endoscope. The Aurora system enables minimally invasive access, visualization and […]
FDA approves Axonics sacral neuromod for FI
Axonics Modulation Technologies (NSDQ:AXNX) today said it received FDA approval for its rechargeable sacral neuromodulation device. The rechargeable SNM device is designed to treat urinary and bowel dysfunction in adults and features a neurostimulator about the size of a USB drive that lasts 15 years in the body. Irvine, Calif.-based Axonics also has a pre-market approval […]
This medtech expert survived a brain tumor: Here’s what he learned
Bill Betten has developed medical devices for decades, but he gained a deeper understanding after hearing a doctor speak the words “brain” and “tumor.” “It’s a little different when it’s going to be done to you,” Betten recalled today during the latest podcast at MassDevice’s sister site Medical Design & Outsourcing. (Hear more from Betten […]
Cerus Endovascular tops $5m funding goal, raises target to $20m
Cerus Endovascular raised its fundraising goal to $20 million this week after it pushed past its previous $5 million target by about $900,000, according to a regulatory filing. The Oxford, U.K.-based company is developing the Contour neurovascular system, which is designed to reduce the risk of rupture when treating patients with intracranial aneurysms. The Contour […]
Nevro launches clinical trial of diabetic neuropathy treatment
Nevro (NYSE:NVRO) said today that it has completed patient enrollment in a clinical trial of its Senza HF10 therapy for patients with painful diabetic neuropathy. The Redwood City, Calif.-based company said the prospective, multicenter, randomized controlled trial compares its HF10 therapy plus conventional medical management to conventional treatment alone in 216 patients at 18 centers in […]
Study shows bioelectronic medicine reduces spasticity in stroke patients
A clinical trial of an investigational, non-invasive medical device has shown that trans-spinal direct-current stimulation and peripheral nerve direct-current stimulation significantly reduced upper-limb spasticity in participants who had experienced a stroke. The treatment involves passing a direct electrical current across the spinal cord with a skin-surface electrode, known as trans-spinal direct-current stimulation (tsDCS), and adding […]
Silk Road Medical proposes $159m stock offering
Silk Road Medical (NSDQ:SILK) has registered a $159 million stock offering to fund its transcarotid artery revascularization (TCAR) technology for the treatment of stroke, according to a regulatory filing. The Sunnyvale, Calif.-based company is proposing an offering of 4.04 million shares of its common stock at a maximum share price of $39.50 each, including 525,000 […]
Integra Lifesciences picks up Arkis Biosciences
Integra LifeSciences (NSDQ:IART) this week acquired Arkis BioSciences and its line of neurosurgery devices for an undisclosed amount. Knoxville, Tenn.-based Arkis makes the CerebroFlo external ventricular drainage catheter that uses its Endexo anti-thrombus additive to prevent blood clots. “Neurocritical care is an important area of focus for Integra. We recently introduced our CereLink intracranial pressure monitor […]
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