FDA clears Neurolief’s noninvasive neuromod tech to treat migraines

Neurolief today announced that it received FDA approval for its Relivion noninvasive neuromodulation system to treat migraines.

The noninvasive, multi-channel brain neuromodulation system is designed to treat acute migraines from home. It is a headset that administers personalized care to patients by delivering stimulation to six branches of the occipital and trigeminal nerves through three adaptive output channels. The output channels allow for the release of neurotransmitters in the brainstem and modulation of brain networks associated with control of pain.

“The FDA clearance of the Relivion noninvasive device is an important event for those suffering from migraines, as it is the only neuromodulation technology thus far that has demonstrated statistically significant efficacy in providing complete freedom of migraine symptoms within 2 hours after treatment, in a sham-controlled clinical trial,” principal investigator on the pivotal international trial Stewart…

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DTW Podcast: Vizient on PPE, Vicarious on VR-aided robotics and let’s all hope for pumpernickel

This week’s episode of DeviceTalks Weekly is brought to you by the later V, as in Vizient and Vicarious Surgical.

Bharat Sundaram, COO and president of Vizient, will share how the healthcare supplier is strengthening the supply of PPE for hospitals. He’ll also reveal when the company expects to see US hospitals running at pre-COVID levels. Hint: It’ll be a while.

Adam Sachs, CEO of Vicarious Surgical, tells us how the company will put a new round of capital from high-powered investors including Bill Gates and Vinod Khosla to work in developing to develop a surgical system employing robotic and virtual reality technologies. How does the start-up expect to compete with the established leaders in the robotics space?

Co-host Chris Newmarker, executive editor, life sciences, will walk us through the five biggest newsmakers on the MassDevice site involving C.R. Bard, Theranos, and Medtronic. Number one may surprise you, but given the time, perhaps …

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The top 5 MassDevice stories of the week — August 14, 2020

COVID-19 continues to batter medical device companies — not to mention the world as a whole. But some of this week’s top five MassDevice stories demonstrate that medtech companies continue to innovate and ink business deals as they look toward a post-pandemic future.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. Federal appeals court rejects preemption argument from BD’s Bard

The 9th U.S. Circuit Court of Appeals handed down an important medical device preemption opinion as it affirmed a $3.6 million award against Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard in a bellwether lawsuit case over inferior vena cava filters. Read the full story. 

4. Theranos founder Elizabeth Holmes’ trial to start in March

Ex-Theranos CEO Elizabeth Holmes’ federal fraud trial will now start in Ma…

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Neurolief wins FDA breakthrough nod for wearable neuromod for depression

Neurolief announced today that it received FDA breakthrough device designation for its Relivion DP system for treating major depression.

Relivion is a wearable, non-invasive, multi-channel brain neuromodulation device designed as an adjunctive treatment to pharmaceutical management of major depressive disorder (MDD) in adults who haven’t experienced satisfactory improvement from antidepressant medications, according to a news release.

Netanya, Israel-based Neurolief’s Relivion DP is a headset-like device placed on the head to stimulate the release of neurotransmitters in the brainstem and modulate brain networks associated with control of mood. The device transfers mild electrical pulses to the brainstem via six branches of the occipital and trigeminal nerves and can be used in tandem with its smartphone app and a cloud database that allows for remote monitoring and care.

“Gaining FDA recognition of our potential to substantially impact an ar…

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