Theranica Bio-Electronics Archives - Medical Design Sourcing

Theranica lands VA contract for migraine device

(Image courtesy of Theranica)

Theranica announced today that it has signed a contract to supply its Nerivio device to the U.S. Department of Veterans Affairs (VA) for use by veterans who suffer from chronic migraine headaches.

Nerivio is worn on the upper arm for 45 minutes and uses remote electrical neuromodulation to activate the brain’s native conditioned pain modulation mechanism to treat pain and associated migraine symptoms, according to Theranica. Nerivio was cited as one of TIME’s best inventions of 2019 and recently won FDA clearance for use by adolescents.

Get the full story on our sister site, Medical Design & Outsourcing.

FDA clears Theranica device for adolescent migraines

(Image courtesy of Theranica)

Theranica announced today that the FDA has granted expanded clearance for the use of its Nerivio acute migraine treatment device by people 12 years and older.

The use of the device in the treatment of adolescents is supported by a study recently published in Headache. According to the study, 28 of 39 (71%) of the adolescent participants using Nerivio experienced pain relief after two hours while 35% experienced complete freedom from pain. Pain relief and pain freedom were sustained for 24 hours in 90% of cases. Sixty-nine percent of the patients experienced improvement in their functional ability, defined by the ability to do schoolwork and perform “usual activities,” at two hours. There were no device-related serious adverse events.

Get the full story on our sister site, Medical Design & Outsourcing.

Ambu, Boston Sci execs see domination for single-use scopes

Hospital closures connected to COVID-19 have cut into the sales of many medical device companies, but executives at rival makers of single-use scopes say pandemic has only heightened existing concerns about contamination, exposure and cost.

In interviews in this week’s DeviceTalks Weekly Podcast, executives from Ambu A/S and Boston Scientific (NYSE:BSX) said improved technology make single-use scopes as effective as reusable scopes without carrying the price tag or risk of infection traditional scopes require.

Steve Block, president of Ambu US, projected that over the next decade disposable scopes will account for a majority of devices sold, saying they’ll perform better than traditional devices, cost less, and eliminate the risk of infection. “There is just no reason to use a reusable product,” he said. He said Ambu has sold single-use scopes into 96% of the Top 500 hospitals in the US performing bronchoscopies.

Block appeared on the podcast alongside…

The top 5 MassDevice stories of the week — September 11, 2020

From the Theranos case to wearable medical devices, it’s been another busy news week for the medical device industry.

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

5. Bardy Diagnostics names new CEO

Kevin Hykes— who over the years has led companies including Relievant Medical Systems, Metavention and Cameron Health — will take over the corner office at Bardy Diagnostics. Bardy has developed the CAM (Carnation ambulatory monitor) for monitoring cardiac rhythms. Read the full story.

4. Drug companies say they won’t release COVID-19 vaccine until it’s ready

Executives from nine different drug companies announced a pledge to ensure safety with a potential COVID-19 vaccine. “We believe this pledge will help ensure public confidence in the rigorous scienti…

Theranica lands CE mark for migraine device

Theranica announced today that it received CE Mark approval for its Nerivio device for the acute treatment of migraine.

Montclair, N.J.-based Theranica adds European approval just over a year since it received FDA de novo clearance for the neurostimulation device in May 2019. The approval allows for the company to begin marketing the device in 2021 under the new MDR European regulation, according to a news release.

The wearable, smartphone-controlled device is placed on the upper arm at the onset of a migraine attack and uses remote electrical neuromodulation to stimulate a conditioned pain modulation response for pain mitigation.

Additionally, the device has a corresponding phone app to keep track of migraine episodes, offering analytics that allow the patient and a doctor to monitor and tailor specific treatments.

“Nerivio combines clinical efficacy comparable to prescription drugs, with a high safety profile,” Theranica CEO Alon Iro…