Epidural space

GLUCOTRACK’S EPIDURAL GLUCOSE MONITORING SENSOR DEMONSTRATES SUCCESSFUL 30-DAY SAFETY & PERFORMANCE IN LONG-TERM PRECLINICAL STUDY

Retrieved on: 
Donnerstag, Mai 16, 2024

Rutherford, NJ, May 16, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that its implantable continuous glucose monitor has successfully completed 30 days of a 60-day long-term preclinical study on measuring glucose in the epidural space.

Key Points: 
  • The Glucotrack sensor, implanted in the epidural space of animals, closely tracked both blood glucose and a commercially available subcutaneous continuous glucose monitor (CGM) throughout the 30-day period.
  • “We are excited by the performance of our epidural glucose sensor in this long-term study, which builds on the encouraging results from our acute testing,” said Paul V. Goode, PhD, CEO of Glucotrack.
  • Glucotrack previously announced that it had completed preclinical animal testing in an acute setting and had initiated this long-term animal study to assess sustained epidural glucose monitoring performance.
  • While the acute study demonstrated feasibility of accurately measuring glucose in the epidural space over several hours, this long-term study assesses the durability of the epidural glucose sensor measurement over a significantly longer duration of monitoring.

GLUCOTRACK ANNOUNCES EXPANSION OF ITS CONTINUOUS GLUCOSE MONITORING TECHNOLOGY TO EPIDURAL GLUCOSE MONITORING

Retrieved on: 
Dienstag, April 16, 2024

Rutherford, NJ, April 16, 2024 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced that it is expanding its glucose monitoring technology to include measuring glucose in the epidural space. A continuous glucose monitoring system that takes readings in the spinal epidural space may be integrated with existing treatments for patients with Painful Diabetic Neuropathy (PDN).

Key Points: 
  • A continuous glucose monitoring system that takes readings in the spinal epidural space may be integrated with existing treatments for patients with Painful Diabetic Neuropathy (PDN).
  • Combining SCS and continuous glucose monitoring (CGM) could provide several possible advantages, such as simplifying device management for those patients.
  • This is the second application of Glucotrack’s technology for implantable continuous glucose monitoring, in addition to its development of a long-term Continuous Blood Glucose Monitoring (CBGM) system.
  • The results demonstrated the Glucotrack epidural glucose values closely tracked both the blood glucose and subcutaneous CGM values.

Milestone Scientific CEO Provides Letter to Shareholders; Provides Positive Reimbursement Update

Retrieved on: 
Dienstag, Januar 16, 2024

I am proud to report we are making steady progress in advancing commercialization of the CompuFlo technology.

Key Points: 
  • I am proud to report we are making steady progress in advancing commercialization of the CompuFlo technology.
  • Several advisory sites were established across the US that implemented the CompuFlo technology in their practice.
  • The medical decision by physicians to use CompuFlo demonstrates the clinical utility and benefit of the technology in patient care.
  • A review and analysis of claims data shared by providers indicated that roughly one-third of claims have already received positive payor reimbursement.

Omeq Medical Receives FDA Regulatory Clearance for its Smart Device for Epidural Injections

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Dienstag, Mai 9, 2023

MISGAV, Israel, May 9, 2023 /PRNewswire/ -- Omeq Medical Ltd. a portfolio company of The Trendlines Group Ltd. (SGX: 42T) (OTCQX: TRNLY), announced today that it has received regulatory clearance from the United States Food and Drug Administration ("FDA") for its EpiFinder, which assists physicians to accurately position an epidural needle while performing the standard Loss of Resistance ("LOR") technique.

Key Points: 
  • The EpiFinder smart device offers to improve the performance of epidural technique for potentially better outcomes, with the intent to make epidural procedures safer and easier for doctors and patients."
  • Omeq Medical CEO, Lior Margalit remarked, "We are grateful to the anesthesia community that has supported our development.
  • EpiFinder is a sensor-based, battery-operated single-use epidural placement device for safe, accurate epidural injections.
  • The simple, easy-to-use device fits between a standard needle and syringe, requires no capital equipment, and is compatible with standard epidural syringes on the market.

NeuroOne® Successfully Completes Initial Animal Implant of Novel Thin Film Paddle Lead for Spinal Cord Stimulation

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Donnerstag, März 16, 2023

EDEN PRAIRIE, Minn., March 16, 2023 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced the successful completion of an initial animal implant of its novel thin film paddle leads for spinal cord stimulation. The devices are intended for the treatment of patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back and leg pain.

Key Points: 
  • The study evaluated the feasibility of implanting a variety of sizes and shapes of ultra-thin paddle leads in a sheep model.
  • The NeuroOne lead fit comfortably in the epidural space and the veterinary surgeon reported no concerns regarding the placement of the lead.
  • These results demonstrated feasibility for placement of a thin film paddle lead intended to treat chronic back pain due to multiple failed back surgeries.
  • The Company is also developing a percutaneous (through a needle) paddle lead placement system which would eliminate the need for an incision in the patient's back.

Milestone Scientific Announces 510(k) FDA Clearance for the Use of CompuFlo Epidural System in Thoracic Indications

Retrieved on: 
Montag, Februar 27, 2023

ROSELAND, NJ., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE:MLSS), a leading developer of computerized drug delivery instruments that provides painless and precise injections, today announced that its CompuFlo® Epidural System has received 510(k) FDA clearance for use in the thoracic region of the spine, including the cervical thoracic junction.

Key Points: 
  • ROSELAND, NJ., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE:MLSS), a leading developer of computerized drug delivery instruments that provides painless and precise injections, today announced that its CompuFlo® Epidural System has received 510(k) FDA clearance for use in the thoracic region of the spine, including the cervical thoracic junction.
  • This approval expands upon the Company’s prior approval of CompuFlo for use within the lumbar region of the spine, where the focus has been on labor and delivery.
  • An independent study has shown that the CompuFlo Epidural System has the potential to reduce costs associated with morbidity, providing a direct economic benefit to healthcare institutions.
  • The FDA clearance represents a major milestone as it broadens the market opportunity for CompuFlo Epidural System, with approximately 11 million epidural procedures performed in the U.S. on an annual basis.

FlatTech LLC Receives Innovative Technology Contract from Vizient for EpiFaith(R) Syringe for safer epidurals

Retrieved on: 
Montag, Januar 9, 2023

TAIPEI, Jan. 9, 2023 /PRNewswire/ -- FlatTech LLC announced its EpiFaith® Syringe for epidural has received an Innovative Technology contract from Vizient, Inc. the nation's largest member-driven health care performance improvement company. The contract was awarded based on the recommendation of EpiFaith® by hospital experts who serve on one of Vizient's member-led councils, and it signifies to Vizient members unique qualities that potentially bring improvement to the health care industry.

Key Points: 
  • TAIPEI, Jan. 9, 2023 /PRNewswire/ -- FlatTech LLC announced its EpiFaith® Syringe for epidural has received an Innovative Technology contract from Vizient, Inc. the nation's largest member-driven health care performance improvement company.
  • Innovative Technology contracts are recommended after review and interaction with products submitted through Vizient's Innovative Technology Program.
  • Through its Innovative Technology Program , Vizient works with member-led councils and task forces to evaluate products for their potential to bring real innovation to health care.
  • Vizient may award a contract to products deemed worthy of the Innovative Technology designation outside of the competitive bid cycle.

Accuro Epidural Guidance Device Demonstrated Superior for Spinal Anesthesia Administration Compared to Palpation & Conventional Ultrasound in a Parturient With Extreme Obesity

Retrieved on: 
Dienstag, August 16, 2022

As reported in the study, a patient requesting epidural analgesia for labor presented with a calculated BMI of 64.5 kg.

Key Points: 
  • As reported in the study, a patient requesting epidural analgesia for labor presented with a calculated BMI of 64.5 kg.
  • Secondarily, acquiring standard ultrasound imaging of the lumbar spine was ineffective in identifying target structures due to the amount of subcutaneous tissue.
  • It may offer a new advantage in improving outcomes and training for operators not experienced in neuraxial ultrasound techniques.
  • RIVANNA's technology platform combines the benefits of ultrasound with bone imaging capabilities of x-ray to fill unmet clinical needs.

Global Electroceuticals / Bioelectric Medicine Industry Report 2022 with Analysis of 50 Players, Including Abbott Labs, Biotronik, Boston Scientific Corp, Cochlear, and Medtronic - ResearchAndMarkets.com

Retrieved on: 
Freitag, Januar 28, 2022

The "Electroceuticals / Bioelectric Medicine - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Electroceuticals / Bioelectric Medicine - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • The heightened pace of research in the area of bioelectric medicine is also likely to boost future business.
  • This segment currently accounts for a 14.8% share of the global Electroceuticals / Bioelectric Medicine market.
  • The presence of leading medical device makers including Boston Scientific Corporation, Medtronic and BIOTRONIK in the region augurs well for the market.

Milestone Scientific Commences Sales of CompuFlo® Epidural Disposables within Prominent Pain Clinic with Leading Physician

Retrieved on: 
Donnerstag, Januar 6, 2022

Dr. Govil plans to utilize the CompuFlo Epidural instrument for office-based procedures to safely and quickly access the epidural space.

Key Points: 
  • Dr. Govil plans to utilize the CompuFlo Epidural instrument for office-based procedures to safely and quickly access the epidural space.
  • Dr. Govil commented, I am excited to incorporate Milestone Scientifics CompuFlo Epidural instrument into my practice, as I believe it represents an advancement in pain management.
  • The instrument provides real-time feedback and confirmation of epidural placement, which offers a number of advantages in terms of safety and efficacy.
  • Arjan Haverhals, CEO and president of Milestone Scientific, stated, We are delighted to announce that another major thought leader has incorporated the CompuFlo Instrument into his pain practice at a nationally recognized institution.