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Neurological

Warning Letter: FDA Allege Wavi is Selling Unapproved Neurological Device Warning Letter: FDA Allege Wavi is Selling Unapproved Neurological Device

While the company states the device doesn’t need IDE or premarket approval because they claim its use is for research purposes only, FDA disagrees.

byKatie Hobbins

Nov 7, 2023|

2 Min Read

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What Does the Future Hold for Assure Holdings?What Does the Future Hold for Assure Holdings?

Sep 20, 2023

2 Min Read

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Medtronic Is Closing the Loop on Spinal Cord Stimulation Medtronic Is Closing the Loop on Spinal Cord Stimulation

byAmanda Pedersen

Sep 6, 2023

2 Min Read

brain-computer interface

BCI Study Helps Voiceless Woman Communicate BCI Study Helps Voiceless Woman Communicate

byKatie Hobbins

Sep 1, 2023

4 Min Read

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Artificial Intelligence

How AI Is Enhancing Nevro's Therapies for Chronic Pain How AI Is Enhancing Nevro's Therapies for Chronic Pain

Aug 30, 2023

13 Min Read

Nerivio Migraine Device Snags Expanded CE Mark Nerivio Migraine Device Snags Expanded CE Mark

byKatie Hobbins

Aug 9, 2023

1 Min Read

brain-computer interface

Neuralink Raises $280M in Financing While Federal Probes Linger

Neuralink Raises $280M in Financing While Federal Probes Linger

byKatie Hobbins

Regulatory & Quality

Why Is Penumbra Playing Hide and Seek with Information?

Why Is Penumbra Playing Hide and Seek with Information?

byAmanda Pedersen

Medical technology

Regulatory & Quality

FDA Expands TAP Pilot to Include Neurological, Physical Medicine Devices

FDA Expands TAP Pilot to Include Neurological, Physical Medicine Devices

byKatie Hobbins

neuropsychiatric disorders

Magnus Medical Starts Treatment in Neuromodulation System Study for Major Depression

Magnus Medical Starts Treatment in Neuromodulation System Study for Major Depression

byKatie Hobbins

cardioversion procedure using a defibrillator machine

Medtronic Warns That Cardioversion May Damage Neurostimulation Devices

Medtronic Warns That Cardioversion May Damage Neurostimulation Devices

byAmanda Pedersen

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Medtech in a Minute: Baxter Bows out of Biopharma, and More

Medtech in a Minute: Baxter Bows out of Biopharma, and More

byAmanda Pedersen

CEO Bernd Montag at the annual shareholders’ meeting 2023 of Siemens Healthineers.

Siemens Calls It Quits in Robotic Heart Surgery

Siemens Calls It Quits in Robotic Heart Surgery

byAmanda Pedersen

Businessman getting ready to flick the CEO icon off the top of a tiered stack of wooden cubes, illustrating CEO change

LivaNova CEO Departure Follows Pipeline Disappointments

LivaNova CEO Departure Follows Pipeline Disappointments

byAmanda Pedersen

Chinese currency shown in the background with a gavel and the China flag, and a downward arrow representing the impact of

Medical Device Regulations

China's VBP Regulation Impacts Medtronic Sales

China's VBP Regulation Impacts Medtronic Sales

byAmanda Pedersen

Medtronic MiniMed 780G insulin pump system for diabetes management

Medtronic Growth Catalysts to Watch for in 2023

Medtronic Growth Catalysts to Watch for in 2023

byAmanda Pedersen

trophy cup with flag of Ireland, representing the Irish Medtech Awards

Ireland Hails J&J Biz as Medtech Company of the Year

Ireland Hails J&J Biz as Medtech Company of the Year

byAmanda Pedersen

Axonics Touts Health Canada Nod for 4th Generation Neurostimulator

Axonics Touts Health Canada Nod for 4th Generation Neurostimulator

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Feds Probe Neuralink Over Animal Testing Practices

Feds Probe Neuralink Over Animal Testing Practices

byKatie Hobbins

The Intersection of Neuromodulation & Personalized Medicine

The Intersection of Neuromodulation & Personalized Medicine

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Musk Proclaims Neuralink Could Start Human Trials in Six Months

Musk Proclaims Neuralink Could Start Human Trials in Six Months

byKatie Hobbins

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NeuroPace RNS System Treats First LGS Patient in IDE Study

NeuroPace RNS System Treats First LGS Patient in IDE Study

byKatie Hobbins

PFO Closure for Migraine Relief?

PFO Closure for Migraine Relief?

bySusan Shepard

An image of the NeuroOne sEEG electrode used for diagnostic brain mapping procedures.

NeuroOne Tried Again – And Succeeded

NeuroOne Tried Again – And Succeeded

byAmanda Pedersen

Xilin Liu, a researcher at the University of Toronto, tests signal integrity of a prototype neural implant, which can be

Combining AI and Microelectronics to Make a Better Brain Implant

Combining AI and Microelectronics to Make a Better Brain Implant

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Medtech in a Minute: A Phoenix Rises, and More

Medtech in a Minute: A Phoenix Rises, and More

byAmanda Pedersen

Medtronic Teases Collaboration Platform for Stroke Innovation

Medtronic Teases Collaboration Platform for Stroke Innovation

byAmanda Pedersen

Tivic Health to Acquire Assets of Reliefband

Tivic Health to Acquire Assets of Reliefband

bySusan Shepard

Photo illustration of a man holding a smartphone with the text "And the survey says" showing on the screen.

Urologist Survey Good for Teleflex, Bad for Axonics

Urologist Survey Good for Teleflex, Bad for Axonics

byAmanda Pedersen

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Is HFES a Solution to Reducing Opioid Use & Treating Chronic Pain?

Is HFES a Solution to Reducing Opioid Use & Treating Chronic Pain?

byKatie Hobbins

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Thin, Flexible Electrode May Reduce Hospitalizations and Surgeries

Thin, Flexible Electrode May Reduce Hospitalizations and Surgeries

bySusan Shepard

Abbott Uses Spinal Cord Stimulation to Treat Pain in 6 Areas

Abbott Uses Spinal Cord Stimulation to Treat Pain in 6 Areas

Medtronic Updates Investors on Key Product Pipelines

Medtronic Updates Investors on Key Product Pipelines

byAmanda Pedersen

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SyncThink to Bring Eye-Tracking Tech to Europe

SyncThink to Bring Eye-Tracking Tech to Europe

byAmanda Pedersen

Hand written words "try again" with green underline and check mark.

Regulatory & Quality

NeuroOne Tries Again for Long-Term sEEG Clearance

NeuroOne Tries Again for Long-Term sEEG Clearance

byAmanda Pedersen

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