CE marking

CVRx to Report Third Quarter 2021 Financial and Operating Results and Host Conference Call

Thursday, October 21, 2021 - 9:05pm

The Company will host a conference call to review its results at5:30 p.m. Eastern Timethe same day.

Key Points: 
  • The Company will host a conference call to review its results at5:30 p.m. Eastern Timethe same day.
  • To listen to a live webcast, please visit the Investors section of the CVRx website at: ir.cvrx.com/investor-relations.
  • The webcast replay will be available on the CVRx website for 12 months following completion of the call.
  • The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure.

Integrity Applications Announces the Appointment of Paul V. Goode, PhD, as President and Chief Operating Officer

Thursday, October 21, 2021 - 3:00pm

Paul has served as a member of Integritys Board of Directors since December 17, 2020.

Key Points: 
  • Paul has served as a member of Integritys Board of Directors since December 17, 2020.
  • Concurrent with his new appointment, Mr. Goode will be stepping down from the Board.
  • Paul is a highly accomplished medical device professional with extensive experience in all areas of operations and product development, from initial concept to global commercialization.
  • Integrity Applications Inc. is a Delaware corporation, with headquarters in the United States and an R&D site in Ashdod, Israel.

PharmaJet, WHO and BMGF Conduct Somalia Polio Vaccination Campaign

Thursday, October 21, 2021 - 2:10pm

The PharmaJet needle-free system was chosen for the Somalia campaign because the published data1 demonstrated improved coverage and user preferences.

Key Points: 
  • The PharmaJet needle-free system was chosen for the Somalia campaign because the published data1 demonstrated improved coverage and user preferences.
  • Additionally, fractional dose delivery, enabled by Tropis, provides a cost-saving alternative to traditional delivery methods and can extend limited stocks.
  • Of the healthcare workers surveyed, 100% said that using needle-free injectors could increase vaccination rates.
  • Chris Cappello, President and CEO, PharmaJet, said, We are pleased to be part of the polio immunization efforts in Somalia to eradicate this terrible disease.

Nocturnal Product Development and Galen Data Announce Cloud Connected Medical Device Partnership

Wednesday, October 20, 2021 - 8:10pm

N.C., Oct. 20, 2021 /PRNewswire-PRWeb/ -- Nocturnal Product Development, LLC (Research Triangle Park, NC) has entered into a strategic partnership with Galen Data, Inc (Houston, TX) to provide an end-to-end, secure, compliant, cost-effective cloud solution for its medical device clients.

Key Points: 
  • N.C., Oct. 20, 2021 /PRNewswire-PRWeb/ -- Nocturnal Product Development, LLC (Research Triangle Park, NC) has entered into a strategic partnership with Galen Data, Inc (Houston, TX) to provide an end-to-end, secure, compliant, cost-effective cloud solution for its medical device clients.
  • This partnership will allow us to bring their cloud connected medical devices to market even faster," says KC Armstrong, President and Founder of Nocturnal Product Development, LLC .
  • Nocturnal Product Development, LLC is a medical device development firm located near Research Triangle Park, Durham, North Carolina.
  • All types and sizes of medical device companies, from the early stage to Fortune 500, have partnered with Galen Data to solve their medical device connectivity needs.

LumiraDx receives approval for its COVID-19 Antigen Test for use in India

Wednesday, October 20, 2021 - 12:03pm

The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.

Key Points: 
  • The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.
  • The LumiraDx SARS-CoV-2 Antigen test is a microfluidic test run on the LumiraDx point of care Platform whichscales down, and integrates techniques used in laboratory analyzers to provide lab-comparable diagnostic tests on a single point of care instrument.
  • "Our launch in India with our SARS-CoV-2 Antigen test is an important step forward in this mission.
  • LumiraDx has, on the market and in development, 30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform.

LumiraDx receives approval for its COVID-19 Antigen Test for use in India

Wednesday, October 20, 2021 - 12:03pm

LONDON, Oct. 20, 2021 /PRNewswire/ -- Today, LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics testing company announced it has received emergency use approval by India's Central Drugs Standard Control Organisation for its SARS-CoV-2 Antigen test for use in India. The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application. In clinical studies, LumiraDx SARS-CoV-2 Antigen test demonstrated a 97.6% positive agreement and 96.6% negative agreement with the PCR test for patients within the first twelve days of symptom, making it one of the fastest, and most sensitive antigen point of care tests currently commercially available. The test has been available in the US and Europe after receiving Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) in August 2020 and having obtained CE Mark in September 2020 respectively.   

Key Points: 
  • LONDON, Oct. 20, 2021 /PRNewswire/ --Today, LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics testing company announced it has received emergency use approval by India'sCentral Drugs Standard Control Organisation for its SARS-CoV-2 Antigen test for use in India.
  • The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.
  • The LumiraDx SARS-CoV-2 Antigen test is a microfluidic test run on the LumiraDx point of care Platform whichscales down, and integrates techniques used in laboratory analyzers to provide lab-comparable diagnostic tests on a single point of care instrument.
  • "Our launch in India with our SARS-CoV-2 Antigen test is an important step forward in this mission.

Biobeat Expands Access of Wearable Cuffless 24 Hour Ambulatory Blood Pressure Device to Consumers

Tuesday, October 19, 2021 - 2:54pm

PETAH TIKVA, Israel, Oct. 19, 2021 /PRNewswire/ -- Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that it has made its new wearable and ambulatory blood pressure chest-monitoring device accessible to consumers. Launched in May 2021 for providers, the consumer-focused device can now be purchased from the Biobeat website.

Key Points: 
  • PETAH TIKVA, Israel, Oct. 19, 2021 /PRNewswire/ -- Biobeat , a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that it has made its new wearable and ambulatory blood pressure chest-monitoring device accessible to consumers.
  • Launched in May 2021 for providers, the consumer-focused device can now be purchased from the Biobeat website.
  • The device measures systolic and diastolic blood pressure, as well aspulse rate, mean arterial pressure, cardiac output, and systemic vascular resistance.
  • Biobeat's wearable devices are the first devices to be FDA-Cleared for cuffless non-invasive PPG-based blood pressure and are also fully CE Mark certified.

Biobeat Expands Access of Wearable Cuffless 24 Hour Ambulatory Blood Pressure Device to Consumers

Tuesday, October 19, 2021 - 2:51pm

PETAH TIKVA, Israel, Oct. 19, 2021 /PRNewswire/ -- Biobeat , a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that it has made its new wearable and ambulatory blood pressure chest-monitoring device accessible to consumers.

Key Points: 
  • PETAH TIKVA, Israel, Oct. 19, 2021 /PRNewswire/ -- Biobeat , a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that it has made its new wearable and ambulatory blood pressure chest-monitoring device accessible to consumers.
  • Launched in May 2021 for providers, the consumer-focused device can now be purchased from the Biobeat website.
  • The device measures systolic and diastolic blood pressure, as well aspulse rate, mean arterial pressure, cardiac output, and systemic vascular resistance.
  • Biobeat's wearable devices are the first devices to be FDA-Cleared for cuffless non-invasive PPG-based blood pressure and are also fully CE Mark certified.

Nuwellis Selected as a Recipient of the Governor’s International Trade Award

Tuesday, October 19, 2021 - 1:00pm

EDEN PRAIRIE, Minn., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ: NUWE) was honored last week with the 2021 Governor's International Trade Award by Minnesota Governor Tim Walz.

Key Points: 
  • EDEN PRAIRIE, Minn., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ: NUWE) was honored last week with the 2021 Governor's International Trade Award by Minnesota Governor Tim Walz.
  • It also recognizes the tremendous positive effect that exports and trade have on the state's overall economy.
  • Nuwellis has increased employment in Minnesota due to the increased product demand, both domestically and internationally.
  • A diversified global trade network helps ensure that Minnesotas economy remains strong as we continue to showcase our ingenuity and innovation on the global stage.

JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System

Monday, October 18, 2021 - 9:03pm

IRVINE, Calif., Oct. 18, 2021 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the first commercial implants with the Trilogy Heart Valve System in Europe.

Key Points: 
  • IRVINE, Calif., Oct. 18, 2021 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the first commercial implants with the Trilogy Heart Valve System in Europe.
  • The Trilogy Heart Valve System is the first and only transfemoral TAVR system in the world approved for the treatment of aortic regurgitation.
  • We are clearly thrilled about the first commercial implants of the Trilogy Heart Valve System in Europe.
  • 1The Trilogy Heart Valve System is indicated for severe, symptomatic aortic regurgitation and severe, symptomatic aortic stenosis in high surgical risk patients.