PMA

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Retrieved on: 
Dienstag, April 2, 2024
Chronic kidney disease, DCB, Kidney disease, Patient, Arteriovenous fistula, IDE, Sirolimus, Quality of life, Trial of the century, Fistula, Clinical trial, Kidney, AVF, PMA, US FDA, Safety, Food, FDA, Health, Pharmaceutical industry

Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

Key Points: 
  • Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
  • The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.
  • This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V.
  • With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients' lives worldwide.

ChannelAssist Inc. and Impartner Software Forge Strategic Partnership to Revolutionize Channel Sales Engagement and Performance

Retrieved on: 
Mittwoch, März 27, 2024
Reward, Channel, Communication, Partnership, Education, PRM, SKU, Ecosystem, PMA, Sales

TORONTO, March 27, 2024 /PRNewswire-PRWeb/ -- ChannelAssist Inc. and Impartner Software are thrilled to announce a new partnership to transform channel sales engagement and performance. This partnership combines the strengths of Impartner's cutting-edge Partner Relationship Management (PRM) capabilities with ChannelAssist's comprehensive incentive and reward solutions. This integration heralds a new era for companies seeking to design, promote, and execute their ideal Channel program amidst a complex total partner lifecycle and ecosystem.

Key Points: 
  • ChannelAssist Inc. and Impartner Software have formed a partnership to revolutionize channel sales by merging ChannelAssist's incentive and reward solutions with Impartner's advanced Partner Relationship Management capabilities, aiming to enhance efficiency, engagement, and profitability for companies in indirect sales channels.
  • TORONTO, March 27, 2024 /PRNewswire-PRWeb/ -- ChannelAssist Inc. and Impartner Software are thrilled to announce a new partnership to transform channel sales engagement and performance.
  • This partnership combines the strengths of Impartner's cutting-edge Partner Relationship Management (PRM) capabilities with ChannelAssist's comprehensive incentive and reward solutions.
  • Derek Smith, Vice President of Global Sales & Partnerships of ChannelAssist, emphasizes, "This partnership with Impartner Software is a game-changer for the industry.

Implantica submits U.S. FDA Premarket Approval (PMA) application for RefluxStop® (first module)

Retrieved on: 
Mittwoch, März 27, 2024
Cancer, PPI, CE, PMID, Patient, Internet, PMA, Literature, File, Gastroesophageal reflux disease, FDA, Certification, Pharmaceutical industry

The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application.

Key Points: 
  • The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application.
  • This process provides for ongoing review and feedback from the FDA as the modules are submitted.
  • The second and third (final) modules are anticipated to be submitted to the FDA in three-month intervals later this year.
  • Dr. Peter Forsell, CEO of Implantica, says, "This FDA filing is a key fundamental milestone for RefluxStop®3 and puts us in motion for the U.S. launch preparation ahead of the pending FDA approval.

Implantica completes Human Factors Validation Study for RefluxStop™ as part of the US FDA Premarket Approval Process

Retrieved on: 
Dienstag, März 26, 2024
Cancer, PPI, PMID, Gastroesophageal reflux disease, Patient, Internet, Foregut, GERD, Northwestern University, Surgeon, Certification, PMA, Literature, Human factors and ergonomics, FDA, Pharmaceutical industry

), a medtech company at the forefront of bringing advanced technology into the body, announces completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop™.

Key Points: 
  • ), a medtech company at the forefront of bringing advanced technology into the body, announces completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop™.
  • In March, 16 foregut surgeons in the United States (U.S.) participated in a Human Factors Validation Study of the RefluxStop™ procedure at Northwestern University's Simulation Lab in Chicago.
  • In the next step of the study, an independent third party is evaluating the data collected during testing in Chicago.
  • Dr. Peter Forsell, CEO of Implantica, says, "We're very grateful to the independent US surgeons and healthcare professionals who participated in the Human Factors Validation study, a key milestone for the FDA approval process.

PMA Assurances and PMT ROY unveil their new brand image

Retrieved on: 
Montag, März 18, 2024
Name, PMT, Ellipse, PMA

PMA Assurances ("PMA") and PMT ROY Assurances et services financiers ("PMT ROY") announce that the combined firms will henceforth be known as Ellipse Assurances.

Key Points: 
  • PMA Assurances ("PMA") and PMT ROY Assurances et services financiers ("PMT ROY") announce that the combined firms will henceforth be known as Ellipse Assurances.
  • "We are very proud to introduce our new name, Ellipse Assurances.
  • Under this banner, our current and future customers will find a diverse product range and, above all, a positive and reassuring insurance purchasing experience," announced Patrice Jean, President of Ellipse Assurances.
  • Ellipse Assurances is the product of the merger announced on December 7, 2023, between PMA and PMT ROY, two pillars of the industry with 94 and 97 years of combined experience, respectively.

EQS-News: Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic

Retrieved on: 
Mittwoch, März 13, 2024
Senior, Biotechnology, NPV, PMA, Messenger, Next Generation, FDA, Partnership, PPV, Marketing, Food, CRC, AA, Biomarker, Science, Quest Diagnostics, THA, Patient, Clinical trial, Survival, DRS, Colorectal cancer, Gene expression

Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic

Key Points: 
  • Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic
    The issuer is solely responsible for the content of this announcement.
  • Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic
    Dr. Jay Wohlgemuth, former Chief Medical & Scientific Officer of Quest Diagnostics and Dr. Ray Tabibiazar, a seasoned industry executive, to lead collaboration
    BERKELEY, US – MAINZ, Germany – March 5, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announced today a partnership with Trusted Health Advisors (THA), a market leader in supporting the U.S. launches and management of commercial programs for diagnostic products.
  • In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test.
  • The Company currently commercializes its first-generation test in Europe and in select international territories through its flagship product ColoAlert® via partnerships with third-party laboratories.

Patriot Mobile Action Celebrates David Covey Forcing Dade Phelan into a Runoff

Retrieved on: 
Donnerstag, März 7, 2024
Hearing, PMA, Republican, Barack Obama, Democrat, Statehouse, Gun Owners of America, House, Get out the vote, Movement, Voting

David Covey secured the highest number of votes, but did not get over 50%, sending this election into a runoff.

Key Points: 
  • David Covey secured the highest number of votes, but did not get over 50%, sending this election into a runoff.
  • This concerted effort is essential for David Covey to secure victory over Dade Phelan.
  • Recognizing the need for change, Patriot Mobile Action supported David Covey, a candidate who embodies the values of liberty, integrity, and accountability.
  • Patriot Mobile Action heavily publicized David Covey’s endorsements, including President Donald J. Trump, Texas Lt. Gov.

InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Mittwoch, März 6, 2024
CMS, Pi, Growth, Radiology, IDE, State university system, CAD, Buffalo, PMA, MDR, TEL, Medical device regulation, Health, Stroke, CAS, TCAR, EPS, EFS, Thomas Jefferson University, European, Carotid artery stenosis, Myocardial infarction, CE marking, Vascular disease, Thrombectomy, Clinical trial, Medicaid, NPS, CEA, Good Samaritan Hospital, Stenosis, Risk, Blood vessel, Medicare, Death, Stent, Patient, Medicine, NSPR, Pharmaceutical industry

TEL AVIV, Israel and MIAMI, March 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • Fourth Quarter 2023 and Recent Developments:
    Generated record CGuard revenue in the fourth quarter 2023 of $1.76 million, a 71.6% increase over the fourth quarter of 2022.
  • Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of 74.5%.
  • Financial Results for the Fourth Quarter Ended December 31, 2023
    For the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022.
  • Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter of 2022.

Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic

Retrieved on: 
Dienstag, März 5, 2024
Senior, Biotechnology, NPV, PMA, Messenger, FDA, Partnership, Marketing, PPV, Food, CRC, AA, Biomarker, Science, Quest Diagnostics, THA, Patient, Clinical trial, Survival, DRS, Colorectal cancer, Gene expression, Medical imaging

In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test.

Key Points: 
  • In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test.
  • The Company currently commercializes its first-generation test in Europe and in select international territories through its flagship product ColoAlert® via partnerships with third-party laboratories.
  • “Detecting AA lesions allows for early intervention and significantly increases the chance of successful treatment and survival.
  • The study’s primary objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA.

Stereotaxis Announces Regulatory Submissions of the MAGiC Ablation Catheter in Europe and the United States

Retrieved on: 
Montag, März 4, 2024
Stellar, PMA, Physician, Hope, CE marking, Patient, Patient safety, Magic, Robotics, Pharmaceutical industry

ST. LOUIS, March 04, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that regulatory submissions were made recently in both Europe and the United States for the MAGiC™ catheter.

Key Points: 
  • ST. LOUIS, March 04, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that regulatory submissions were made recently in both Europe and the United States for the MAGiC™ catheter.
  • Stereotaxis’ MAGiC catheter is a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures.
  • The first human procedures with the MAGiC catheter commenced earlier this year as part of a prospective multi-center clinical study.
  • Stereotaxis anticipates making the MAGiC catheter commercially available for the community of robotic electrophysiologists following receipt of regulatory clearances.