Axilla

Compression Works Receives Additional 510(k) Clearance from the FDA for the AAJT-S Life-Saving Junctional Tourniquet

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Tuesday, March 7, 2023
Groin, Rupture, REBOA, Abdominal aortic aneurysm, Mortality, Traffic, Compression, Pelvis, Blood, Pelvic fracture, Weaver Junction, Bleeding, Falls, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Abdomen, Food, U.S. Department of Commerce Office of Security, FDA, Aorta, Axilla, Transport, Anatomy, Medical device, Dietary supplement, MD

BIRMINGHAM, Ala., March 7, 2023 /PRNewswire-PRWeb/ -- Compression Works, Inc. manufacturer of the Abdominal Aortic and Junctional Tourniquet-Stabilized (AAJT-S) device, announces a new 510(k) clearance from the FDA. This is the third 510(k) clearance granted by the U.S. Food and Drug Administration (FDA) for the AAJT-S technology.

Key Points: 
  • Compression Works, Inc. manufacturer of the Abdominal Aortic and Junctional Tourniquet-Stabilized (AAJT-S) device, announces a new 510(k) clearance from the FDA.
  • BIRMINGHAM, Ala., March 7, 2023 /PRNewswire-PRWeb/ -- Compression Works, Inc. manufacturer of the Abdominal Aortic and Junctional Tourniquet-Stabilized (AAJT-S) device, announces a new 510(k) clearance from the FDA.
  • This is the third 510(k) clearance granted by the U.S. Food and Drug Administration (FDA) for the AAJT-S technology.
  • With the additional FDA clearance for pelvic fractures, the AAJT-S offers more multi-use capabilities for critical areas of the body to help save lives.

Changing Breast Cancer Treatment with the NeoNavia® Biopsy System

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Tuesday, October 25, 2022
Lymph, Time, Diagnosis, Patient, Nasdaq, Cancer, Swelling, Breast cancer, Axilla, Breast, Face, Lymphedema, Nursing, FDA, Medical imaging

STOCKHOLM, Oct. 25, 2022 /PRNewswire/ -- NeoDynamics AB (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, announced today that it is launching the NeoNavia biopsy system configured with its FlexiPulse probe in the United States to support the diagnosis of cancer.

Key Points: 
  • "The recent FDA clearance of the NeoNavia will help clinicians address the critical issues they face in diagnosing and treating breast cancer, which are the proper detection of cancerous tumors in the breast and its spread beyond," said Anna Eriksrud, CEO of NeoDynamics.
  • She continued, "The US breast biopsy market is expected to reach $830mm by 2025.
  • NeoNavia is designed to be the optimal tool to perform both the breast and axillary biopsy during a single patient visit with one system.
  • The US launch of the NeoNavia biopsy system with the FlexiPulse probe is scheduled for January 2023.

NeoDynamics received FDA clearance for pulse biopsy system NeoNavia®

Retrieved on: 
Thursday, September 8, 2022
Breast cancer, Breast, Needle, CEO, Medtech, Research, NEOD, Karolinska Institutet Prize for Research in Medical Education, Neoplasm, US Foods, Food, Diagnosis, Biopsy, Karolinska Institute, Lymph, Axilla, Nasdaq, FDA, CE, Marketing, Patient, Medical device, Pharmaceutical industry, Medical imaging

STOCKHOLM, Sept. 8, 2022 /PRNewswire/ -- The MedTech company NeoDynamics has today received approval for its innovative pulse biopsy system NeoNavia from the US Food and Drug Administration, FDA.

Key Points: 
  • STOCKHOLM, Sept. 8, 2022 /PRNewswire/ -- The MedTech company NeoDynamics has today received approval for its innovative pulse biopsy system NeoNavia from the US Food and Drug Administration, FDA.
  • "The FDA approval for NeoNavia is a major milestone for NeoDynamics and a stamp of quality for both the product and NeoDynamics as a whole," said Anna Eriksrud, CEO of NeoDynamics.
  • The company's first product NeoNavia, a new innovative pulse biopsy system for ultrasound guided tissue sampling, is currently being introduced to the market.
  • NeoNavia is a modern biopsy system with a completely new patented pulse technology intended for ultrasound-guided tissue sampling.

NeoDynamics received FDA clearance for pulse biopsy system NeoNavia®

Retrieved on: 
Thursday, September 8, 2022
Breast cancer, Breast, Needle, CEO, Medtech, Research, NEOD, Karolinska Institutet Prize for Research in Medical Education, Neoplasm, US Foods, Food, Diagnosis, Biopsy, Karolinska Institute, Lymph, Axilla, Nasdaq, FDA, CE, Marketing, Patient, Medical device, Pharmaceutical industry, Medical imaging

STOCKHOLM, Sept. 8, 2022 /PRNewswire/ -- The MedTech company NeoDynamics has today received approval for its innovative pulse biopsy system NeoNavia from the US Food and Drug Administration, FDA.

Key Points: 
  • STOCKHOLM, Sept. 8, 2022 /PRNewswire/ -- The MedTech company NeoDynamics has today received approval for its innovative pulse biopsy system NeoNavia from the US Food and Drug Administration, FDA.
  • "The FDA approval for NeoNavia is a major milestone for NeoDynamics and a stamp of quality for both the product and NeoDynamics as a whole," said Anna Eriksrud, CEO of NeoDynamics.
  • The company's first product NeoNavia, a new innovative pulse biopsy system for ultrasound guided tissue sampling, is currently being introduced to the market.
  • NeoNavia is a modern biopsy system with a completely new patented pulse technology intended for ultrasound-guided tissue sampling.

New data from NeoDynamics' PULSE study presented at major US breast imaging conference

Retrieved on: 
Tuesday, May 17, 2022
Medical Affairs Bureau, Breast, Thoracic wall, Pain, Axilla, Breast cancer, Patient, PULSE, Karolinska Institute, SBI, Muscle, Research, Needle, Conference, Karolinska Institutet Prize for Research in Medical Education, Biopsy, Neoplasm, Lymph, Diagnosis, Medical imaging

The new data was presented by Professor Marc Thill at the SBI/ACR Breast Imaging Symposium in Savannah, Georgia.

Key Points: 
  • The new data was presented by Professor Marc Thill at the SBI/ACR Breast Imaging Symposium in Savannah, Georgia.
  • The conference, taking place on May 16-19, is held to be the most important annual meeting for US breast imaging professionals.
  • That the new data was selected for oral presentation at the US conference indicates a strong interest in the results among breast biopsy specialists.
  • The study illustrates the significant contribution NeoNavia can provide, particularly in difficult and complex breast and axilla biopsies.

Comprehensive Scientific Study Demonstrates Compression Works' AAJT-S Device Useful in Traumatic Cardiac Arrest and Non-Compressible Truncal Hemorrhage Patients

Retrieved on: 
Tuesday, May 3, 2022
Annals, Annals of Emergency Medicine, Axilla, Bleeding, Gaps, Meta-analysis, Metal–semiconductor junction, Hypovolemic shock, Abdomen, Traumatic cardiac arrest, Patient, Trauma, FDA, Emergency medicine, Knee, Zone 3 of Milan, Arrest, EMS, CEO, Abdominal aortic aneurysm, Pelvic fracture, Meat, Medical imaging, Medical device, Hospital, Aorta

BIRMINGHAM, Ala., May 3, 2022 /PRNewswire-PRWeb/ -- Compression Works, creators of the Abdominal Aortic and Junctional Tourniquet-Stabilized (AAJT-S) device, announces the publication of a new trauma review article in the Annals of Emergency Medicine, "External Aortic Compression in Noncompressible Truncal Hemorrhage and Traumatic Cardiac Arrest: A Scoping Review." The study examines aortic compression as it relates to non-compressible truncal hemorrhage and traumatic cardiac arrest subjects.

Key Points: 
  • A new trauma review article in the Annals of Emergency Medicine examines aortic compression as it relates to non-compressible truncal hemorrhage and traumatic cardiac arrest subjects.
  • The study examines aortic compression as it relates to non-compressible truncal hemorrhage and traumatic cardiac arrest subjects.
  • The AAJT-S device by Compression Works is currently FDA cleared to treat non-compressible hemorrhages in the axilla, abdomen and groin region.
  • "With over 70 scientific studies published about the Compression Works' life-saving device, the AAJT-S is the most studied device in its class.

NeoDynamics has filed for registration of NeoNavia® in the US

Retrieved on: 
Tuesday, March 1, 2022
Karolinska Institute, Physician, Karolinska Institutet Prize for Research in Medical Education, Lymph, Neoplasm, Needle, Diagnosis, Medtech, Breast cancer, Food, Breast, FDA, US Foods, Marketing, Patient, Biopsy, Research, CE, Axilla, Medical imaging

STOCKHOLM, March 1, 2022 /PRNewswire/ -- The MedTech company NeoDynamics has filed a registration application for its innovative pulse biopsy system NeoNavia with the US Food and Drug Administration, FDA.

Key Points: 
  • STOCKHOLM, March 1, 2022 /PRNewswire/ -- The MedTech company NeoDynamics has filed a registration application for its innovative pulse biopsy system NeoNavia with the US Food and Drug Administration, FDA.
  • "By filing for registration of NeoNavia in the US, NeoDynamics reaches an important milestone.
  • The US is a huge potential market for NeoNavia and a US registration is also an important seal of quality for future collaborations", says CEO Anna Eriksrud.
  • "We expect that it will take a number of months to get the registration application approved."

New data from NeoDynamics PULSE study accepted for presentation at major US breast imaging conference

Retrieved on: 
Thursday, January 20, 2022
Patient, Research, Needle, Biopsy, Breast cancer, Medical Affairs Bureau, Neoplasm, Karolinska Institute, Diagnosis, PULSE, Axilla, NEOD, SBI, Cancer, Breast, Karolinska Institutet Prize for Research in Medical Education, Lymph, Medical imaging

The symposium is held to be the most important annual meeting for US breast imaging professionals.

Key Points: 
  • The symposium is held to be the most important annual meeting for US breast imaging professionals.
  • "The NeoNavia device has demonstrated great performance in the most challenging subgroup of cases in the PULSE study.
  • The SBI/ACR Breast Imaging Symposium is the most important annual meeting for breast imaging professionals in the US, usually attracting over 1 000 participants.
  • The pulse biopsy system has been used for tissue sampling in breast and axilla in over 500 patients.

Sensus Healthcare Expects Record 4Q 2021 Sales and Continued Growth in 1Q 2022; Profiles New Product at the 2022 Winter Clinical Dermatology Conference

Retrieved on: 
Wednesday, January 5, 2022
ART, Brachytherapy, COVID-19, Dermatology, Government, Hyaluronic acid, Research, Forward-looking statement, Patient, CME, Axilla, Keloid, Quality of life, Conference, U.S. Securities and Exchange Commission, Annual report, Security (finance), Risk, Lidocaine, Awareness, CEO, Marketing, FDA, BOCA, Legislation, Diagnosis, Terminology, GLOBE, Center, SRT, Nasdaq, EBITDA, Industry, Cosmetic, Collagen, Perspiration, Tax, Pharmaceutical industry, Medical device, SensUs

Based upon expectations for shipments during the current quarter, the company also expects to be profitable for the first quarter of 2022.

Key Points: 
  • Based upon expectations for shipments during the current quarter, the company also expects to be profitable for the first quarter of 2022.
  • Sensus expects to report 2021 financial results and hold an investment community conference call in February.
  • Sensus also announces that its TransDermal Infusion System non-invasive drug delivery system for cosmetic and other dermatology applications will be featured at the 2022 Winter Clinical Dermatology Conference - Hawaii.
  • Mr. Sardano added, We are excited that our TransDermal Infusion System will be highlighted by Dr. Nestor at the Winter Dermatology Clinical.

Global Axillary Hyperhidrosis Market Opportunity Assessment and Forecast Report 2021-2030 - ResearchAndMarkets.com

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Wednesday, December 15, 2021
Health, Other Health, Epidemiology, Insurance, Education, Hyperhidrosis, Perspiration, Life, Awareness, Diagnosis, Contact dermatitis, Growth, AH, Industry, D, Genetics, Exocrine gland, Review, Skin, Disease, Therapy, Deodorant, Attention deficit hyperactivity disorder predominantly inattentive, Disorder, Axilla, Wool, Medical device, Pharmaceutical industry

The "Axillary Hyperhidrosis - Opportunity Assessment and Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Axillary Hyperhidrosis - Opportunity Assessment and Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.
  • The main driver to growth in the AH market is the sales of high-priced neuromuscular blockades represents the most impactful driver of growth for the AH market.
  • What are the main R&D trends in the axillary hyperhidrosis market and which companies are leading the way?
  • Topline AH market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.