Tagged fda
Press Release
Recardio and FDA Reach Agreement on Pivotal Phase 3 Trial Design
Recardio Inc., a late stage clinical-stage life science company developing regenerative therapies for cardiovascular diseases, announced that the FDA concurs with Recardio's pivotal Heal-MI Phase 3 trial design with Dutogliptin in Acute Myocardial Infarction. Read More
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Caddo Mountain Spring Water, LLC Announces Plans for a New $24 Million Premium Water Bottling Facility in the Caddo Mountains of Arkansas
Company's Premium Water Bottling Facility will be State-of-the-Art. The Company's Plant will be a U.S. Advanced Manufacturing Plant by virtue of its design, engineering, and sustainability. Read More
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POMSnet Falcon Dives Into Pharma and Biotech GMP Facilities Across the Globe
POMS Corporation unveils a game changer in MES Dashboards & Batch Records for Pharma, Biotech, and Cell and Gene manufacturers. POMSnet Falcon swoops in and shatters the paradigm of electronic batch record visualization with a stunning original design. Go faster and see farther with POMSnet Falcon. Read More
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Bidi Vapor Forges Ahead With Product-Specific Studies to Meet FDA's Rigorous Public Health Standard for Marketing ENDS
E-cig maker committed to demonstrating BIDI® Stick ENDS is appropriate for the protection of the public health, flavored products provide added benefit for adult cigarette smokers while outweighing potential risk to youth Read More
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VoluMetrix's NIVA|HF for Heart Failure Patients Designated as Breakthrough Device by U.S. FDA
NIVA|HF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients. As a Breakthrough Device, NIVA|HF will receive pre-market developmental assistance and prioritized regulatory review from FDA. NIVA|HF is the first application of VoluMetrix's proprietary venous waveform technology. Read More
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EndoFresh Obtains FDA 510(k) Clearance for Its Groundbreaking Disposable Digestive Endoscopy System
EndoFresh reveals its novel Disposable Digestive Endoscopy System with full advantages of potential clinical application, patient safety and financial implication, which is approved by the FDA and CE. It is perfect for gastrointestinal endoscopy, effectively helping physicians in ICU, ER, outpatient clinic, GI suite and bed-side treatment, especially during post-pandemic era. Read More
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Dr. Rajamannan of Most Sacred Heart of Jesus Cardiology Prepared to Review Successful Novel Therapies to Mitigate Covid-19 in the Outpatient Setting
Covid-19 has infected over 90.4 Million Worldwide and 50.1Million have recovered and 1.94 Million have died, the goal is to work together to mitigate this disease. Read More
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Invitrx Therapeutics Profiled on BioInformant About Co-Sponsoring Baylx, Inc's US FDA Approved Umbilical Cord Tissue Mesenchymal Stem Cells Product for COVID-19
Invitrx Therapeutics' continued efforts to be the leader in innovative cellular therapy had just recently been reinforced with the company's collaboration with Baylx, Inc. (Baylx) to co-sponsor and spearhead the clinical trial of Baylx's FDA approved IND for COVID-19 indication using Human Umbilical Cord Tissue Mesenchymal Stem Cells (hUC-MSC) product, as featured by BioInformant on November 23, 2020. This publication can be seen in full at https://bioinformant.com/invitrx-baylx-covid-19. Read More
Press Release
Dr. Rajamannan of Most Sacred Heart of Jesus Cardiology Holds Virtual Press Conference on Outpatient Therapies for Covid-19
Dr. Nalini M. Rajamannan discusses options for patients who test Covid-19 to slow progression of disease from her medical practice located in Sheboygan WI. Read More
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ComplianceQuest Announces the Launch of CQ Care FastStart EDMS Solution - a Free Service to Help Companies Overcome Business Challenges Caused by the Current Covid-19 Pandemic
The CQ Care Solution includes ComplianceQuest's Document and Learning Management Solutions, as well as LearnAboutGMP Video-based Online Regulatory Training, Deployed so Customers Can Go from Sign-Up to Go-Live in Five Days. Read More
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ComplianceQuest Announces the Launch of LearnAboutGMP - an On-Demand, Video Based Regulatory Training Service Designed Specifically for Life Science Organizations
Video based On-line Regulatory Training ComplianceQuest's End-to-End Enterprise Document and Learning Management Solutions Read More
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On Martin Luther King Day, Illinois and Minnesota Attorney Generals and Chicago City Mayor Lori Lightfoot Receive FDA Testimonies on Non-Exempt Medical Device as FDA Delays to Not Inform the Patients as Confirmed by Dr. Rajamannan
Minneapolis FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens Read More
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Governor Pritzker Receives FDA Testimonies on Non-Exempt Medical Device as FDA Delays to Not Inform the Patients Across the United States as Confirmed by Dr. Rajamannan at Most Sacred Heart of Jesus Cardiology and Valvular Institute
FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens across the United States Read More
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January 2020, Dr. Rajamannan Confirms Minneapolis FDA Investigation of Newly Released Non-Exempt Status to Senator Amy Klobuchar's Minneapolis Senate Office
Releasing FDA Congressional letter to Senator Charles Grassley (IA), confirming heart valve status on the eve of the Iowa Debates Read More
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