CE marking

PharmaJet Needle-free System Selected to Deliver Intradermal Polio Vaccine in Nigerian Campaign

Retrieved on: 
Tuesday, November 8, 2022
Health, Medical Supplies, Medical Devices, CE marking, United Nations, Review, Global Polio Eradication Initiative, U.S. FDA, LGA, World Health Organization, Injection, Sias, GPEI, Vaccine, Certification, Stockholm Environment Institute US Center, Gavi, Centers for Disease Control and Prevention, UNICEF, Public health, OPV, PQS, Polio, World, Use, Partnership, Bill & Melinda Gates Foundation, IPV, System, CDC, Rotary International, Multimedia, Research, Paralysis, WHO, CEO

View the full release here: https://www.businesswire.com/news/home/20221108005025/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221108005025/en/
    Kangethe Ngure, Regional Director for Africa, PharmaJet, demonstrating Tropis device use to trainers in Sokoto, Nigeria.
  • The Nigeria pilot campaign will combine the nOPV2 oral vaccine with an intradermal polio vaccine (1/5 of a full IPV dose) administered with the PharmaJet Tropis NFIS.
  • We are pleased to be selected for the polio vaccine campaign in Nigeria to curtail the spread of cVDPV2, said Chris Cappello, President and CEO of PharmaJet.
  • Intradermal administration of polio vaccine with the PharmaJet Tropis NFIS has already been successfully used in mass vaccination campaigns in Somalia, Pakistan, Cuba, and The Gambia.

Baebies Receives FDA 510(k) Clearance for G6PD Test on FINDER Platform

Retrieved on: 
Wednesday, November 9, 2022
Food, CE marking, Infection, AACC, YouTube, AAP, FAAP, FDA, Patient, Association, Blood, Chemistry, Stanford University School of Medicine, Emory University School of Medicine, Kernicterus, American Association, Bilirubin, Digital microfluidics, Jaundice, Heart rate, Food and Drug Administration, Pathology, Hematology, Hemolytic anemia, American Association for Clinical Chemistry, Microfluidics, Doctor of Philosophy, Innovation, Disruptive innovation, Fatigue, Paleness, DMF, Pediatrics, Anemia, Health, G6PD, Solution, Child, Research, Glucose-6-phosphate dehydrogenase deficiency, Male, Technology, District Programme Manager, CEO, Medical device, Pharmaceutical industry, Medicine, Vaccine, MD, Maternal–fetal medicine

DURHAM, N.C., Nov. 9, 2022 /PRNewswire/ -- Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Key Points: 
  • DURHAM, N.C., Nov. 9, 2022 /PRNewswire/ -- Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • The test is run on the FINDER platform, which features a toaster-sized instrument and a disposable cartridge.
  • Test results display G6PD enzyme activity in units per gram of hemoglobin and adjusted male median values.
  • With G6PD as the first FDA-cleared test on our FINDER platform, we look forward to adding many additional types of tests to the versatile and multifunctional platform."

ProciseDx Announces FDA Clearance of ProciseDx instrument and C Reactive Protein (CRP) Assay

Retrieved on: 
Tuesday, November 8, 2022
Workflow, CE marking, Serum, TDM, CRP, Inflammatory bowel disease, FDA, Patient, Blood, Membrane protein, Adalimumab, Therapeutic drug monitoring, SAN, IBD, De novo, Mimms, Point of care, GI, Gastroenterology, IVD, Chairperson, Commercialization, Health, Infliximab, Technology, Medical imaging, Pharmaceutical industry, Medical device, Risk management, COVID-19

SAN DIEGO, Nov. 8, 2022 /PRNewswire/ -- ProciseDx Inc. announces FDA clearance of its ProciseDx instrument and C reactive Protein (CRP) test. Procise CRP gives quantitative determination of CRP levels in patient serum in less than 5 minutes. ProciseDx expects FDA clearances of additional tests in 2023.

Key Points: 
  • SAN DIEGO, Nov. 8, 2022 /PRNewswire/ -- ProciseDx Inc. announces FDA clearance of its ProciseDx instrument and C reactive Protein (CRP) test.
  • A first FDA Clearance is an important validation of ProciseDx's new technology.
  • For the US market, ProciseDx has submitted De Novo applications to the FDA for two TDM tests.
  • "FDA Clearance is major achievement for the ProciseDx team Biosynex has supported the development and commercialization of the ProicseDx platform.

IceCure's ProSense® Achieves Significant Milestone in Medicare Coverage of Breast Cancer Procedures

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Tuesday, November 8, 2022
Food, CE marking, Center, NASDAQ, Genta (company), Risk, Centers for Medicare & Medicaid Services, CMS, FDA, TASE, SEC, Patient, Company, Private Securities Litigation Reform Act, ICE3, Clinical trial, De novo, Breast cancer, Food and Drug Administration, Lidocaine, Classification, U.S. Securities and Exchange Commission, Policy, Medicare, CPT, Neoplasm, Disease, Dentist, Kidney, Woman, Marketing, Annual report, Securities & Exchange Commission of Pakistan, Freezing, Technology, Breast, Health insurance, Pharmaceutical industry, Medical imaging

(NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing, today announced the Centers for Medicare & Medicaid Services ("CMS") assigned its ProSense breast cancer cryoablation procedures with CPT Category III code 0581T to ambulatory payment classification 5091, Level 1 Breast/Lymphatic Surgery and Related Procedures.

Key Points: 
  • (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing, today announced the Centers for Medicare & Medicaid Services ("CMS") assigned its ProSense breast cancer cryoablation procedures with CPT Category III code 0581T to ambulatory payment classification 5091, Level 1 Breast/Lymphatic Surgery and Related Procedures.
  • A De Novo Classification Request for breast cancer marketing authorization was filed with the FDA for the initial breakthrough indication of early-stage low-risk breast cancer patients at high risk to surgery in October 2022.
  • Backed by its ICE3 clinical trial interim analysis data of ProSense, IceCure's application is the first and only Medicare coverage approval of cryoablation procedurefor breast cancer.
  • "This Medicare Payment Group assignment is a significant milestone that will support our commercialization of ProSense for early-stage breast cancer if we receive FDA marketing authorization.

Tivic Health Takes Bioelectronic Medicine to HTLH

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Monday, November 7, 2022
Health, FDA, Medical Devices, Health Technology, General Health, Clinical Trials, Biotechnology, Walmart, Awareness, Research, Therapy, LLC, Mount Sinai, Icahn School of Medicine at Mount Sinai, Pain, FDA, Best, System, Trial of the century, Nasdaq, Common, Nausea, Vomiting, Clinical trial, Annual report, CE marking, De novo, Congestion, Forward-looking statement, Pressure, Inflammation, Goal, Allergy, SEC, Traction, Amazon, Pharmaceutical industry, EU

Tivic Health Systems , Inc. (Nasdaq: TIVC) (Tivic Health), a commercial-phase health technology company focused on bioelectronic medicine, is bringing bioelectronic medicine to HTLH with ClearUP, an FDA-approved and clinically proven device that uses low-level electrical stimulation to treat sinus pain and congestion from allergies, colds, and flu.

Key Points: 
  • Tivic Health Systems , Inc. (Nasdaq: TIVC) (Tivic Health), a commercial-phase health technology company focused on bioelectronic medicine, is bringing bioelectronic medicine to HTLH with ClearUP, an FDA-approved and clinically proven device that uses low-level electrical stimulation to treat sinus pain and congestion from allergies, colds, and flu.
  • Key goals of ours are to grow consumer awareness of bioelectronic therapies and to advance these non-invasive drug-free technologies toward becoming mainstream treatment options for common health conditions, said Blake Gurfein, chief scientific officer of Tivic Health.
  • We intend to continue to pioneer bioelectronic medicine research and to grow a trusted brand that builds and delivers evidence-based, safe, and effective bioelectronic therapies.
  • Tivic Health Systems, Inc. is a commercial-phase health technology company delivering non-invasive bioelectronic treatments that provide consumers with a choice in the treatment of inflammation and immune-related conditions.

Oriental Yuhong Appeared at the 13th International Infrastructure Investment and Construction Forum

Retrieved on: 
Monday, November 7, 2022
People, Benchmark, Belt, Macao Special Administrative Region passport, Forum, Sale, Multimedia, SBS, Property Owned by the Central People's Government in the Hong Kong Special Administrative Region, Industry, CNY, Project, Building material, Belt and Road Initiative, Travel, Marketing, Macau, Liaison Office, CE marking, Oriental Yuhong, Environment, China International Contractors Association, Association, Retail, Renewable energy, EU

BEIJING, Nov. 7, 2022 /PRNewswire/ -- During September 28-29, 2022 (Beijing time), the 13th International Infrastructure Investment and Construction Forum, sponsored by the China International Contractors Association, was successfully held in Macao.

Key Points: 
  • BEIJING, Nov. 7, 2022 /PRNewswire/ -- During September 28-29, 2022 (Beijing time), the 13th International Infrastructure Investment and Construction Forum, sponsored by the China International Contractors Association, was successfully held in Macao.
  • Kou Jianan, the person in charge of international engineering projects of Oriental Yuhong, exchanged with the audience on how enterprises deal with adversity as a guest of this parallel forum.
  • He stressed that, Oriental Yuhong always takes customer needs as the center, and provides all customers with undifferentiated high-quality products.
  • In the future, Oriental Yuhong will persevere in empowering infrastructure construction in a quicker response with better products and more systematic and professional services.

CVRx Launches new Barostim NEO2™ Implantable Pulse Generator

Retrieved on: 
Thursday, November 3, 2022
Heart, GLOBE, European Economic Area, FDA, Hypertension, CEO, Physician, Longevity, CE marking, NASDAQ, Autonomic nervous system, IPG, Patient, Heart failure, Medical device

MINNEAPOLIS, Nov. 03, 2022 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its new Barostim NEO2™ IPG.

Key Points: 
  • The new Barostim NEO2 Implantable Pulse Generator (IPG) launches in the U.S., improving the patient experience while on therapy and simplifying the implant procedure for physicians
    MINNEAPOLIS, Nov. 03, 2022 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (CVRx), developer of the worlds first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its new Barostim NEO2 IPG.
  • The Barostim NEO2 also offers a streamlined design with a single lead port (compared with two in the prior generation device) to further simplify the implant procedure.
  • The new Barostim NEO2 offers the same clinically proven Barostim Therapy, but with a more convenient design for my patients that is smaller and lasts longer, said Dr. Michael Hoosien, electrophysiologist at Piedmont Atlanta.
  • "The new Barostim NEO2 is another leap forward in improving the patient and provider experience with Barostim Therapy," said Nadim Yared, President and CEO of CVRx.

CVRx to Attend Upcoming Investor Conferences

Retrieved on: 
Thursday, November 3, 2022
GLOBE, European Economic Area, Degenerative disease, Autonomic nervous system, FDA, Heart failure, Heart, Hypertension, CE marking, Canaccord Genuity, Patient, Pharmaceutical industry, Medical device

MINNEAPOLIS, Nov. 03, 2022 (GLOBE NEWSWIRE) -- CVRx, Inc. (CVRx), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced thatthe management team will participate in the following upcoming investors conferences on Thursday, November 17, 2022:

Key Points: 
  • MINNEAPOLIS, Nov. 03, 2022 (GLOBE NEWSWIRE) -- CVRx, Inc. (CVRx), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced thatthe management team will participate in the following upcoming investors conferences on Thursday, November 17, 2022:
    For more information on the conferences or to schedule a one-on-one meeting with CVRx, please contact your respective Canaccord Genuity or Craig-Hallum representative, or CVRx's investor relations at [email protected] .
  • CVRx is focused on the development and commercialization of Barostim, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure.
  • Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery.
  • The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure.

Data Validating EDTA Blood as Sample Type for SeptiCyte® RAPID Presented at the Association for Molecular Pathology 2022 Annual Meeting

Retrieved on: 
Thursday, November 3, 2022
PCR, Gene expression, FDA, Association, Mycosis, Technology, Infection, Institute, Falls, Sepsis, Patient, Vital signs, University Hospital Bonn, PDT, Medical microbiology, Associate, Poster, Partnership, EDTA, CE marking, Teaching hospital, RNA, Medical device, Medical imaging, Parasitology, EU

SEATTLE and BRISBANE, Australia, Nov. 3, 2022 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the presentation of an abstract at the Association for Molecular Pathology 2022 Annual Meeting in Phoenix. The abstract, entitled, "Multi-site validation of EDTA blood as a sample type for SeptiCyte® RAPID CE-IVD, a near-patient diagnostic test for sepsis on the Biocartis Idylla™ System," will be presented as a poster on Saturday, November 5, 2022 from 9:15 – 10:15 a.m. PDT.

Key Points: 
  • It investigated Immunexpress' sepsis diagnostic tool SeptiCyte RAPID CE-IVD in 46 clinically confirmed sepsis and non-sepsis patients.
  • The reproducibility of the EDTA blood result was further assessed by running a subset of the samples in triplicate.
  • "These data validate the use of undiluted EDTA-anticoagulated blood as an additional sample type for the SeptiCyte RAPID CE-IVD assay.
  • In March 2020, Immunexpress received CE Marking of SeptiCyte RAPID and announced a commercialization partnership with Biocartis in Europe.In November 2021, Immunexpress received FDA clearance for SeptiCyte RAPID.

Baseus Just Rolled Out an Unprecedented Innovative GaN Power Strip

Retrieved on: 
Thursday, November 3, 2022
Digital, PD, Apple, Research, USB, LED, Bluetooth, Temperature, Smartphone, IPhone, Technology, Pentawards, Idea, Red Dot, Gallium nitride, IF, Baseus, Weather, Amazon, Efficiency, AliExpress, Safety, IPad, Video game console, CE marking

HONG KONG, Oct. 31, 2022 /PRNewswire/ --Baseus Technology Ltd., the industry-leading consumer electronics brand is here with a new GaN power strip under the series name PowerCombo.

Key Points: 
  • HONG KONG, Oct. 31, 2022 /PRNewswire/ --Baseus Technology Ltd., the industry-leading consumer electronics brand is here with a new GaN power strip under the series name PowerCombo.
  • To break that stereotype and give users a brand new experience in contrast with regular power strips, the Baseus PowerCombo Pro 40W Power Strip was designed.
  • It's the baby of a power strip and GaN charger.
  • The Baseus PowerCombo 40W Power Strip is an all-in-one desktop charging solution, and it is now available on big platforms like Amazon , AliExpress, and other online shopping websites.