From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia […]
These medtech companies raised the most VC last year
Perhaps there’s a ray of hope that venture capital funding is recovering a bit for the medical device industry. VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There were a total 229 deals involving […]
NeuroPace touts 8-year brain-responsive neurostim trial data
NeuroPace today released eight-year prospective clinical study data from trials of its closed-loop brain-responsive neurostimulation system, touting a 73% median seizure reduction among patients. Data from the trials was presented at the American Epilepsy Society’s annual meeting in Washington D.C. this week, the Mountain View, Calif.-based company said. The data came from 256 adult patients across […]
NeuroPace raises $74m for anti-epilepsy implant
NeuroPace said today that it raised a $74 million funding round, saying it plans to use the infusion to speed the commercialization of its implantable neurostimulation device for treating epilepsy. Mountain View, Calif.-based NeuroPace said the round was led by the KCK Group and OrbiMed Advisors. NeuroPace’s RNS system monitors electrical activity in the brain, delivering stimulative therapy […]
NeuroPace touts 7-year data on RNS neurostim therapy for epilepsy
NeuroPace today released 7-year follow-up data from a clinical trial of its RNS neurostimulation system designed to prevent epileptic seizures, touting an over-70% reduction in seizure frequency. The company’s RNS system is a closed-loop brain-responsive neurostim system designed for preventing epileptic seizures, and has been approved by the FDA as adjunctive therapy to treat partial […]
DARPA taps NeuroPace for memory loss trial
Epilepsy treatment devices maker NeuroPace hopes to expand its clinical applications by supporting a research initiative to evaluate neurostimulation implants in treatment of memory deficits.
FLASH: FDA approves NeuroPace’s anti-epilepsy implant
FDA regulators today announced that they granted premarket approval for NeuroPace for its anti-epilepsy device, an implantable neurostimulator that helps prevent seizures.
Second Sight’s ‘bionic eye’ conquers Cleveland Clinic’s ‘Top 10’
Cleveland Clinic this week announced its picks for the top 10 medical innovations of 2014, placing the newly FDA-approved Argus II "bionic eye" from Second Sight in the #1 spot.
The device is a breakthrough for the U.S., designed to restore meaningful eyesight to patients suffering from retinitis pigmentosa, a condition that leaves patients with either bare light perception or none at all. There is currently no cure for the rare condition, which is diagnosed about 250 times each year.
Details on the FDA panel’s NeuroPace deliberations
An FDA advisory panel last week debated who should be allowed to implant NeuroPace’s anti-epilepsy device, where it should be implanted and which patients should be eligible for it on the way to recommending approval for the implant.
The federal watchdog agency’s Neurological Devices Advisory Panel, in a non-binding vote Feb. 22, recommended that the FDA approve NeuroPace’s RNS deep-brain stimulation therapy for certain categories of epilepsy, but had some reservations about the details
FDA panel recommends approval of NeuroPace’s anti-epilepsy implant
California neurostimulation devices maker NeuroPace crept 1 step closer to an FDA win for its epilepsy implant with near-unanimous approval from the FDA’s Neurological Devices Advisory Panel.
NeuroPace’s epilepsy implant lands a date with the FDA after more than 2 years
California medical device maker NeuroPace is finally getting a date with the FDA to review its premarket application for a neuromodulation implant for patients with epilepsy.
NeuroPace filed its application in July 2010 for its RNS System, hoping to win indication as an adjunct therapy for reducing seizures in patients aged 18 and older.
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