CE marking

IceCure's ProSense Featured in Poster Presentation at Radiological Society of North America's 2022 Annual Meeting

Retrieved on: 
Wednesday, November 30, 2022
CMS, Interventional radiology, Kidney, Food, Poster, RSNA, Centers for Medicare & Medicaid Services, Update, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, Annual report, FDA, Radiological Society of North America, Annual general meeting, Classification, De novo, MD, Breast cancer, Interim, Neoplasm, Medicare, Diagnosis, CentraState Medical Center, Genta (company), LINK, Risk, TASE, ICE3, Securities & Exchange Commission of Pakistan, Clinical trial, CE marking, Breast, Freezing, Medical imaging

That Is The Question: Cryoablation For The Treatment Of Breast Cancer"

Key Points: 
  • That Is The Question: Cryoablation For The Treatment Of Breast Cancer"
    CAESAREA, Israel, Nov. 30, 2022 /PRNewswire/ -- IceCure Medical Ltd .
  • (Nasdaq: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing, today announced that ProSense is featured in a poster presentation titled "To Freeze Or Not To Freeze?
  • That Is The Question: Cryoablation For The Treatment Of Breast Cancer" at RSNA 2022 , the Radiological Society of North America's ("RSNA") 108th Scientific Assembly and Annual Meeting which takes place from November 27th to December 1st, 2022 in Chicago.
  • RSNA is the largest radiology society in the world with over 48,000 members in the United States, representing 31 radiologic sub-specialties sharing state-of-the-art radiological innovations.

Egg Medical Receives CE Mark for EggNest™ Radiation Protection System Release

Retrieved on: 
Wednesday, November 30, 2022
Hypertension, Anatomy, Wilson, Multimedia, Risk, X-ray, Angioplasty, Radiology, Physician, Workflow, Radiation, CE marking, Paola Lattus, Carbon, Cancer, CE, Cataract, Electrophysiology, Cardiac catheterization, Medical imaging

ARDEN HILLS, Minn., Nov. 30, 2022 /PRNewswire/ -- Egg Medical, Inc ., a medical device company commercializing technologies to reduce scatter radiation exposure during interventional angiographic procedures, today announced that it has achieved CE Mark for the EggNest XR radiation protection system.

Key Points: 
  • ARDEN HILLS, Minn., Nov. 30, 2022 /PRNewswire/ -- Egg Medical, Inc ., a medical device company commercializing technologies to reduce scatter radiation exposure during interventional angiographic procedures, today announced that it has achieved CE Mark for the EggNest XR radiation protection system.
  • With the CE Mark certification, Egg Medical will continue expansion into all markets recognizing the CE Mark.
  • "With CE mark approval of the EggNest platform, we are bringing this protection to more interventional teams worldwide."
  • The EggNest XR is a comprehensive, scatter radiation protection system fully integrated into the workflow of the modernCath Lab.

SurgiBox's safe surgery solutions complete CE Marking for two of its products and obtain Humanitarian Use Exemption in Ukraine for the SurgiField System

Retrieved on: 
Wednesday, November 30, 2022
Pressure, Battery pack, Disposable product, CE marking, Hospital, Patient, Exemption, HEPA, Atmosphere, Dust, ISO, Safety, Medical device

CAMBRIDGE, Mass., Nov. 30, 2022 /PRNewswire/ -- SurgiBox Inc. today announced CE Marking for its Smart Control Module 001-SCM-0000 and its Battery Pack BP-04002M.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 30, 2022 /PRNewswire/ -- SurgiBox Inc. today announced CE Marking for its Smart Control Module 001-SCM-0000 and its Battery Pack BP-04002M.
  • SurgiBox has obtained Humanitarian Use Exemption for the use of the SurgiField System in Ukraine.
  • SurgiBox was founded in 2017 by doctors and entrepreneurs dedicated to improving access to safe surgical care and is an ISO 13485:2016-certified quality management system company.
  • "We are delighted these updates allow us to start to deliver this eagerly-awaited technology to support safe surgery at the point of need."

The Worldwide Remote Drone Identification System Industry is Expected to Reach $4 Million by 2032 at a 3.5% CAGR

Retrieved on: 
Tuesday, November 29, 2022
Growth, Country, Energy, Region, LTE, Fortification, Unifly, Government, PTAC, UTM, Altitude, CE marking, Accident, Halo, ID, FCC, DICE, Bluetooth, GSM, Investment, Medical device, Mobile phone, Risk management

The global remote drone identification system market was valued at $2.8 million in 2021, and it is expected to reach $4.0 million by 2032, growing at a CAGR of 3.5% during the forecast period 2022-2032.

Key Points: 
  • The global remote drone identification system market was valued at $2.8 million in 2021, and it is expected to reach $4.0 million by 2032, growing at a CAGR of 3.5% during the forecast period 2022-2032.
  • The growth in the global remote drone identification system market is expected to be driven by the enforcement of remote drone identification system regulation and an increase in the number of drones.
  • The global remote drone identification system market is observing rising investment across all the drone platforms, which drives the investments across the remote drone identification technology.
  • Following are the drivers for the global remote drone identification system market:
    Following are the challenges for the global remote drone identification system market:
    Following are the opportunities for the global remote drone identification system market:

TIME CHANGE: IceCure Medical to Report Financial Results for the 9-Month Period Ended September 30, 2022 and Conduct Conference Call on December 5, 2022

Retrieved on: 
Tuesday, November 29, 2022
Serenity, EST, Kidney, Food, Breast, Regulation of tobacco by the U.S. Food and Drug Administration, Annual report, Neoplasm, AME Publishing Company, Wellness, Surgeon, Risk, TASE, CE marking, Breast cancer, Freezing, Medical imaging

The scheduled time of the press release has been corrected to December 5, 2022 at 7:00 a.m. EST and the time of the conference call has been corrected to December 5, 2022 at 8:00 a.m. EST.

Key Points: 
  • The scheduled time of the press release has been corrected to December 5, 2022 at 7:00 a.m. EST and the time of the conference call has been corrected to December 5, 2022 at 8:00 a.m. EST.
  • Dr. Bednarski is a board certified general surgeon with a fellowship in aesthetic breast oncology, and she is known as an oncoplastic breast surgeon.
  • Its minimally invasive technology is a safe and effective alternative to hospital surgical tumorremoval that is easily performed in a relatively short procedure.
  • The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Chembio Announces FDA CLIA Waiver Submission for DPP HIV-Syphilis System

Retrieved on: 
Monday, November 28, 2022
COVID-19, Infection, Vertically transmitted infection, Government, Diagnosis, CDC, Antibody, Food, Blood, Risk, Hospital, EUA, Bacteria, Infant, ANVISA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pregnancy, Patient, System, Annual report, Birth defect, PMA, CLIA, Disease, World Health Organization, DPP, Treponema pallidum, Clinical Laboratory, Coinfection, Sale, Fetus, Stillbirth, CE marking, Congenital syphilis, Woman, HIV, Syphilis, Plasma, FDA, Pharmaceutical industry, Treponema

We are pleased to communicate that our DPP HIV-Syphilis System has been submitted to FDA for CLIA waiver.

Key Points: 
  • We are pleased to communicate that our DPP HIV-Syphilis System has been submitted to FDA for CLIA waiver.
  • Upon receipt of CLIA waiver, we believe this will represent a large step forward in rapid testing for sexually transmitted infections.
  • We appreciate the collaboration with the FDA on this submission and look forward to continued dialog regarding our CLIA waiver application, said RichardL.
  • Chembios portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA).

IceCure Medical to Report Financial Results for the 9-Month Period Ended September 30, 2022 and Conduct Conference Call on December 5, 2022

Retrieved on: 
Monday, November 28, 2022
Serenity, EST, Kidney, Food, Breast, Regulation of tobacco by the U.S. Food and Drug Administration, Annual report, Neoplasm, AME Publishing Company, Wellness, Surgeon, Risk, TASE, CE marking, Freezing, Medical imaging

Dr. Bednarski is a board certified general surgeon with a fellowship in aesthetic breast oncology, and she is known as an oncoplastic breast surgeon.

Key Points: 
  • Dr. Bednarski is a board certified general surgeon with a fellowship in aesthetic breast oncology, and she is known as an oncoplastic breast surgeon.
  • Its minimally invasive technology is a safe and effective alternative to hospital surgical tumorremoval that is easily performed in a relatively short procedure.
  • Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements.
  • The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Annalise.ai Showcases AI Tools for Medical Imaging at RSNA 2022 Annual Meeting and Convention

Retrieved on: 
Sunday, November 27, 2022
United Kingdom, Trauma, University, Regulation of tobacco by the U.S. Food and Drug Administration, Radiological Society of North America, Fujifilm, CT, Critical care, Regulation, Union, Triage, Health, Antioch Hall, North and South Halls, Patient, CTB, Theatre, Radiology, FDA, Growth, Diagnosis, Food, Machine learning, Hospital, Partnership, Global health, Nuance Communications, Booth, RSNA, Annual general meeting, MD, Senior, Neuroimaging, CE marking, Contraindication, MDR, Medical imaging, Medical device, Nightclub, AI, EU

"Our appearance at RSNA 2022 signals our ambition to transform the power of AI in radiology," said Lakshmi Gudapakkam, CEO of Annalise.ai.

Key Points: 
  • "Our appearance at RSNA 2022 signals our ambition to transform the power of AI in radiology," said Lakshmi Gudapakkam, CEO of Annalise.ai.
  • I invite you to visit us at Booth #4757 in the RSNA AI Showcase in the South Hall."
  • The company was cited for its Enterprise CXR tool and its growing list of advances in the radiology space.
  • Our patient-first approach is proudly clinician-led and comes from a deep understanding of the challenges faced in medical imaging.

Achiko AG Announces Corporate Update Webcast

Retrieved on: 
Sunday, November 27, 2022
DNA, School, Nahdlatul Ulama, Hospital, Gold, University, COVID-19, Nanoparticle, CE marking, Union, Vaccine

AptameX is the Companys proprietary saliva-based Covid-19 test utilising DNA aptamers bound to gold nanoparticles in a colloidal solution.

Key Points: 
  • AptameX is the Companys proprietary saliva-based Covid-19 test utilising DNA aptamers bound to gold nanoparticles in a colloidal solution.
  • Achiko AG (SIX: ACHI.SW; OTCQB: ACHKF; www.achiko.com) is developing disruptive diagnostic solutions that put people first.
  • Achiko aims to deliver fast, accurate and affordable diagnostic testing for a range of diseases in the rapidly evolving healthcare diagnostics field.
  • Headquartered in Zurich, Achiko has offices in Jakarta, and staff around the world.

Achiko AG Announces Corporate Update Webcast

Retrieved on: 
Sunday, November 27, 2022
DNA, School, Nahdlatul Ulama, Hospital, Gold, University, COVID-19, Nanoparticle, CE marking, Union, Vaccine

AptameX is the Companys proprietary saliva-based Covid-19 test utilising DNA aptamers bound to gold nanoparticles in a colloidal solution.

Key Points: 
  • AptameX is the Companys proprietary saliva-based Covid-19 test utilising DNA aptamers bound to gold nanoparticles in a colloidal solution.
  • Achiko AG (SIX: ACHI.SW; OTCQB: ACHKF; www.achiko.com) is developing disruptive diagnostic solutions that put people first.
  • Achiko aims to deliver fast, accurate and affordable diagnostic testing for a range of diseases in the rapidly evolving healthcare diagnostics field.
  • Headquartered in Zurich, Achiko has offices in Jakarta, and staff around the world.