Transcutaneous electrical nerve stimulation

MANAMED Receives Expanded 510(k) Clearance for ManaFlexx 2

Retrieved on: 
Thursday, November 16, 2023
Transcutaneous electrical nerve stimulation, Arm, Chronic pain, TENS, EMS, US Foods, Exercise, Shoulder, FDA, Arthritis, System, Neurostimulation, Pain, NMES, Athlete, Leg, Skin, Poultry farming

DENTON, Texas, Nov. 16, 2023 /PRNewswire/ -- The US Food and Drug Administration (FDA) has granted over-the-counter marketing clearance for the ManaFlexx 2®, an Electrical Stimulation (EMS) device, from MANAMED®, LLC. ManaFlexx 2 is a compact medical device that delivers electrical pulses to the user's skin through the company's patented wireless technology for two distinct uses. The expanded indication applies to both ManaFlexx 2 device's indications: Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS).

Key Points: 
  • DENTON, Texas, Nov. 16, 2023 /PRNewswire/ -- The US Food and Drug Administration (FDA) has granted over-the-counter marketing clearance for the ManaFlexx 2®, an Electrical Stimulation (EMS) device, from MANAMED®, LLC.
  • ManaFlexx 2 is a compact medical device that delivers electrical pulses to the user's skin through the company's patented wireless technology for two distinct uses.
  • The expanded indication applies to both ManaFlexx 2 device's indications: Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS).
  • This expanded indication joins the previous FDA clearance granted for the noninvasive device as an adjunctive treatment in the management of post-surgical and post- traumatic acute pain.

New Study Shows Acupuncture Enhances Pregnancy Outcomes in Women Undergoing In Vitro Fertilization

Retrieved on: 
Tuesday, July 18, 2023
Olive, Systematic review, Pregnancy, LBR, Embryo transfer, Woman, Infertility, Meta-analysis, Fertilisation, IVF, Synthetic control method, Patient, Transcutaneous electrical nerve stimulation, LLLT, CPR, Traditional Chinese medicine, Pregnancy rate, Medical device, Birth control, Health care, Acupuncture

VANCOUVER, British Columbia, July 18, 2023 /PRNewswire-PRWeb/ -- A comprehensive systematic review and meta-analysis, conducted by researchers Menghao Xu, Mengdi Zhu, and Cuihong Zheng, has revealed the positive effects of acupuncture on pregnancy outcomes in women undergoing in vitro fertilization (IVF). The study, which was recently published in a leading scientific journal, sheds light on the benefits of acupuncture as an adjunctive therapy in assisted reproductive technology.

Key Points: 
  • The study, encompassing 25 trials with 4757 participants, demonstrated higher clinical pregnancy and live birth rates among acupuncture groups compared to control groups.
  • VANCOUVER, British Columbia, July 18, 2023 /PRNewswire-PRWeb/ -- A comprehensive systematic review and meta-analysis, conducted by researchers Menghao Xu, Mengdi Zhu, and Cuihong Zheng, has revealed the positive effects of acupuncture on pregnancy outcomes in women undergoing in vitro fertilization (IVF).
  • The study , encompassing data from 25 trials with a total of 4757 participants, examined the impact of acupuncture on IVF-FET (in vitro fertilization and embryo transfer) outcomes.
  • According to the researchers, these findings suggest that acupuncture can play a significant role in improving pregnancy outcomes for women undergoing IVF.

electroCore Announces Issuance of Two New U.S. Patents

Retrieved on: 
Wednesday, December 7, 2022
Indigestion, A luta continua, Migraine, Neurology, Adolescence, Nerve conduction study, Patient, Hearing, NVN, Nature, Ear, Hypertension, Disclosure, Marketing, FDA, Medication overuse headache, Patent, Skin, Pain, Neck, Risk, Cluster headache, Gastroparesis, Magnetism, Tachycardia, Union, ElectroCore, Disorder, Ileus, Transcutaneous electrical nerve stimulation, IP, Indometacin, Bradycardia, ECOR, Safety, 1836 U.S. Patent Office fire, Headache, Hemicrania continua, Vagus nerve, Functional gastrointestinal disorder, Hypotension, Medical device, Pharmaceutical industry

11,511,109 entitled “Non-invasive Magnetic or Electrical Nerve Stimulation to Treat Gastroparesis, Functional Dyspepsia, and other Functional Gastrointestinal Disorders” issued on November 29, 2022.

Key Points: 
  • 11,511,109 entitled “Non-invasive Magnetic or Electrical Nerve Stimulation to Treat Gastroparesis, Functional Dyspepsia, and other Functional Gastrointestinal Disorders” issued on November 29, 2022.
  • This patent is generally related to methods for treating gastroparesis, functional dyspepsia and/or ileus with nVNS.
  • 11,517,742 entitled “Non-invasive Vagal Nerve Stimulation to Treat Disorders” issued on December 6, 2022.
  • “The issuance of these two new patents continues to broaden and strengthen the usage of our nVNS therapy across multiple indications and methods,” Dan Goldberger, Chief Executive Officer of electroCore.

Neuromodulation Devices Markets, 2029 - ResearchAndMarkets.com

Retrieved on: 
Monday, November 28, 2022
Medical Devices, Health, Neurology, Other Science, Science, Biotechnology, Webbed toes, Hypoglossal nerve, Hospital, Incidence, TENS, Neuromodulation, Gastroenterology, Degenerative disease, Pain management, SCS, Weaning, Stroke, Epilepsy, Chronic pain, Patient, Anxiety, Government, OSA, Ageing, Heart failure, Parkinson's disease, Transcutaneous electrical nerve stimulation, Obesity, Rheumatoid arthritis, CNS, Autoimmune disease, Central sleep apnea, Obstructive sleep apnea, Functional electrical stimulation, Diabetes, Mood disorder, Obsessive–compulsive disorder, Multiple sclerosis, Urinary incontinence, Urology, OCD, NMES, Movement disorders, Central nervous system, Investment, Pharmaceutical industry, Medical device, Beauty salon, Medicine, Dystonia, Depression, Gastroparesis

The "Neuromodulation Devices Global Market- Forecast To 2029" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Neuromodulation Devices Global Market- Forecast To 2029" report has been added to ResearchAndMarkets.com's offering.
  • The treatment delivered by neuromodulation devices brings about life-changing transformation in patients who fail to get better by traditional approaches.
  • Based on the product, the neuromodulation global market is segmented into invasive neuromodulation devices and non-invasive neuromodulation devices.
  • Among these, invasive neuromodulation devices segment accounted for the highest revenue in 2022 and is expected to grow at an early teen CAGR from 2022 to 2029.

gammaCore Sapphire™ Non-Invasive Vagus Nerve Stimulator (nVNS) Receives Unique National Product Code Number by the Belgian Pharmaceutical Association

Retrieved on: 
Friday, November 18, 2022
COVID-19, Hypertension, Cluster headache, Medication overuse headache, Patient, IP, Skin, Adolescence, Vagus nerve, Bradycardia, Pharmacy, Indometacin, Nature, National Coding Week, Union, Pain, Safety, Overalls, Hemicrania continua, Neurology, Migraine, NVN, APB, Tachycardia, Transcutaneous electrical nerve stimulation, CNK, Senior, A luta continua, News, Hypotension, Nerve conduction study, Hearing, Sapphire, Headache, ElectroCore, ECOR, FDA, Pharmaceutical industry

CNK numbers are unique product code identifiers allocated by the Belgian Pharmaceutical Association (APB) for products and medicines commercially available from pharmacies throughout Belgium and enables product recognition throughout the pharmaceutical network.

Key Points: 
  • CNK numbers are unique product code identifiers allocated by the Belgian Pharmaceutical Association (APB) for products and medicines commercially available from pharmacies throughout Belgium and enables product recognition throughout the pharmaceutical network.
  • We have taken a big step forward in making our therapy more widely available throughout Europe.
  • The publication of the CNK code, makes gammaCore recognized within the Belgian pharmaceutical database and therefore available via any pharmacy in Belgium.
  • When placed on a patients neck over the vagus nerve, gammaCore stimulates the nerves afferent fibers, which may lead to a reduction of pain in patients.

electroCore Announces Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 3, 2022
Patient, Company, Migraine, Private Securities Litigation Reform Act, A luta continua, Skin, Cluster headache, Investment, Hearing, Time, Bradycardia, GAAP, NVN, Medication overuse headache, Headache, Neurology, Industry, Overalls, Indometacin, Hypotension, FDA, Adult, Webcast, Transcutaneous electrical nerve stimulation, EBITDA, Conference, Hypertension, Terminology, COVID-19, ElectroCore, Nature, Nerve conduction study, Research, Vagus nerve, Concussion, Safety, Tachycardia, Hemicrania continua, IP, Absorption, Union, Depreciation, SEC, Pain, Adolescence, Video game, Pharmaceutical industry

ROCKAWAY, N.J. , Nov. 03, 2022 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced third quarter 2022 financial results and provided an operational update.

Key Points: 
  • Gross margin for the third quarter of 2022 was 87%, compared to 76% in the third quarter of 2021.
  • Total operating expenses in the third quarter of 2022 were approximately $7.3 million, as compared to $5.1 million in the third quarter of 2021.
  • Research and development expense in the third quarter of 2022 was $1.6 million as compared to $470 thousand in the third quarter of 2021.
  • Selling, general and administrative expense in the third quarter of 2022 was $5.7 million as compared to $4.6 million in the third quarter of 2021.

electroCore, Inc. Announces Distribution Agreement with Joerns Healthcare, LLC

Retrieved on: 
Tuesday, November 1, 2022
Migraine, Nature, Tachycardia, Hearing, Hypotension, Adult, Medication overuse headache, Cluster headache, Bradycardia, Pain, Partnership, SEC, GLOBE, Patient, Time, LLC, Hypertension, Industry, COVID-19, ECOR, Sapphire, ElectroCore, Nerve conduction study, Hemicrania continua, Overalls, NVN, Indometacin, Terminology, Technology, Vagus nerve, Private Securities Litigation Reform Act, FDA, Union, Skin, Neurology, Safety, Headache, Adolescence, A luta continua, Transcutaneous electrical nerve stimulation, Pharmaceutical industry

Joerns mission is to simplify care delivery so providers can focus on patients needs and payors can be confident that the best value-based therapies are available to their beneficiaries, said Doug Ferguson, Chief Strategy Officer at Joerns Healthcare.

Key Points: 
  • Joerns mission is to simplify care delivery so providers can focus on patients needs and payors can be confident that the best value-based therapies are available to their beneficiaries, said Doug Ferguson, Chief Strategy Officer at Joerns Healthcare.
  • We are excited to be working with Joerns as we expand patient access to our therapy, commentedDan Goldberger, Chief Executive Officer of electroCore.
  • Joerns Healthcare is a healthcare technology and equipment services company focused on driving the transformation of care nationally across the post-acute continuum.
  • We are simplifying the complex post-acute care world by providing the technology, professionals, products, and data to help streamline the process, so providers concentrate on care.

electroCore and Joerns Healthcare Partner to Expand Use Of gammaCore™ Vagus Nerve Technology for Headache Sufferers

Retrieved on: 
Tuesday, November 1, 2022
Migraine, Nature, Tachycardia, Hearing, Hypotension, Adult, Medication overuse headache, Cluster headache, Bradycardia, Pain, Partnership, SEC, Patient, Time, LLC, Hypertension, Industry, COVID-19, Nerve conduction study, Sapphire, ElectroCore, Hemicrania continua, Overalls, NVN, Indometacin, Terminology, Technology, Vagus nerve, Private Securities Litigation Reform Act, Company, FDA, Union, Skin, Neurology, Safety, Headache, Adolescence, A luta continua, Transcutaneous electrical nerve stimulation, Pharmaceutical industry

"We are excited to be working with Joerns as we expand patient access to our therapy," commentedDan Goldberger, Chief Executive Officer of electroCore.

Key Points: 
  • "We are excited to be working with Joerns as we expand patient access to our therapy," commentedDan Goldberger, Chief Executive Officer of electroCore.
  • Joerns Healthcare is a healthcare technology and equipment services company focused on driving the transformation of care nationally across the post-acute continuum.
  • When placed on a patient's neck over the vagus nerve, gammaCore stimulates the nerve's afferent fibers, which may lead to a reduction of pain in patients.
  • gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

electroCore Provides Select Third Quarter 2022 Financial Guidance

Retrieved on: 
Friday, October 14, 2022
International, Vagus nerve, Time, Hypertension, Migraine, Growth, Bradycardia, Patient, Tachycardia, Cluster headache, Timeline of the COVID-19 pandemic, VA, United States Department of Defense, Private Securities Litigation Reform Act, Adolescence, Company, Transcutaneous electrical nerve stimulation, Industry, Department, ECOR, Neurology, United States Department of Veterans Affairs, Department of Defence, Nerve conduction study, Hemicrania continua, Pain, Nature, Indometacin, Adult, United, NVN, Medication overuse headache, Skin, Overalls, GLOBE, European, A luta continua, ElectroCore, Headache, Hearing, Hypotension, Safety, FDA, COVID-19, Terminology, Prescription, Medical device, Video game, Pharmaceutical industry

ROCKAWAY, N.J., Oct. 14, 2022 (GLOBE NEWSWIRE) -- electroCore, Inc. (the Company) (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided select unaudited preliminary financial guidance for the third quarter of 2022.

Key Points: 
  • ROCKAWAY, N.J., Oct. 14, 2022 (GLOBE NEWSWIRE) -- electroCore, Inc. (the Company) (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided select unaudited preliminary financial guidance for the third quarter of 2022.
  • Preliminary unaudited financial guidance for the third quarter of 2022:
    Revenue: The Company anticipates reporting third quarter 2022 revenue of approximately $1,976,000.
  • 113 VA and DoD military treatment facilities purchased gammaCore products through September 30, 2022, as compared to 96 through the third quarter of 2021.
  • Cash Position: The Company ended the third quarter of 2022 with approximately $21.9 million of cash and cash equivalents, compared to $26.6 millionas of the end of the second quarter of 2022.

NeuroSigma Announces Receipt of Permanent HCPCS Codes from CMS for Monarch eTNS System

Retrieved on: 
Tuesday, September 27, 2022
Adult, Centers for Medicare & Medicaid Services, Center, Policy, Medicare, Database, FDA, Food, HCPCS, CMS, Telephony, Product life-cycle theory, DME, ADHD, Anticonvulsant, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Transcutaneous electrical nerve stimulation, Trigeminal nerve, Monarch, Insurance, GLOBE, Monthly, Depression, Health insurance, Pharmaceutical industry

The Monarch eTNS System is a bioelectronic medical device that uses external trigeminal nerve stimulation (eTNS) to treat neurological and neuropsychiatric disorders.

Key Points: 
  • The Monarch eTNS System is a bioelectronic medical device that uses external trigeminal nerve stimulation (eTNS) to treat neurological and neuropsychiatric disorders.
  • "We are extremely pleased that CMS has confirmed the DME benefit category determination and permanent Level II HCPCS codes for the Monarch eTNS System and the single-use NS-2 Electric Patch, said Colin Kealey, M.D., President of NeuroSigma.
  • The company is currently commercializing the Monarch eTNS System to treat pediatric ADHD.
  • For more information on the Monarch eTNS System, please visit www.monarch-etns.com .