From a groundbreaking idea to an FDA-approved screening tool for average risk patients, the growth of the Cologuard® test was no small feat. Hear some of the unforgettable moments from the Cologuard test’s first 10 years, as told by the team that helped make it happen: https://lnkd.in/gTB2xsR5 #10YearsofCologuard
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🆕📝 #TransdermalPatches are designed to deliver active substances through the skin directly into the bloodstream at a prolonged and constant rate. Due to their unique attributes, they present different challenges when controlling their quality, efficacy, and safety. In our latest blog post, we explore the mechanisms by which they work, their regulatory requirements, and how Kymos Group can assist you in their #QualityControl and analysis. ▶ Learn more about them and Kymos' capabilities: https://bit.ly/4aPEPrS
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📊 Diving Deeper into Adverse Events: December 2023 Insights Yesterday, we shared the staggering number of adverse events reported by the FDA in December 2023 - over 179K. But what's behind those numbers? Let's take a closer look at the post-market data from the last 30 days, encompassing all review panels. In the last month alone, our Basil Systems Post Market Module tracked: - 71K Injuries - 858 Deaths - Over 100K Malfunctions See the breakdown below for more information. At Basil Systems, we're committed to empowering you with the tools you need to navigate the complex world of MedTech.Stay informed, stay ahead! Request a free trial of Basil's Post Market Module for more insights: https://lnkd.in/e7igx3ib #AdverseEvents #PatientSafety #DataInsights #BasilSystems #MedTech #postmarketsurveillance #MedicalDevices #FDA #MAUDE #recall
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On Wednesday, May 22nd, the @PharmaSUG is hosting an FDA panel with Helena Sviglin will offer her expertise in FDA Study Data Policy Framework. Y. Veronica Pei, MD, MEd, MPH, FACEP will provide an update to safety outputs, specifically Addressing Data Challenges in Drug Induced Liver Injury. And Stephen Wilson will speak about how volunteers drive this industry forward. #FDA #PharmaSUG #ClinicalTrials #DrugSafety #RegulatoryCompliance
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Watch this @pertconsortium webinar clip as Dr. Robert Lookstein discusses the quality of data from the NIH-sponsored RESCUE Trial, as well as the unsurpassed efficacy and safety of the BASHIR™ Endovascular Catheter in treating PE. Thrombolex.com #Thrombolex
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Deep dive into the tackling of #AMR holistically in the Cepheid Integrated Lunch Panel & Symposium at #ESCMIDGlobal, from a macro, political, clinical, and patient perspective, analysing the key challenges faced, practical solutions, and central role of diagnostics as our best defense against resistance. Register: https://lnkd.in/e6P2688s
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Learn how a sponsor ensured patient supply while limiting drug overage in a high site / low patient #clinicaltrial with Calyx IRT Advanced Trial Supply Management. Read the case study. https://lnkd.in/dbVJYDfD #IRT #RTSM #Randomization #TrialSupplyManagement #ChooseCalyx
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🆕 Penumbra, Inc., the world’s largest #thrombectomy company, recently announced the US Food and Drug Administration’s clearance of Lightning Flash 2.0, a next-generation, computer-assisted, vacuum thrombectomy (CAVT) system to remove venous thrombus and treat #pulmonaryembolism. Lightning Flash 2.0 features advanced Lightning Flash algorithms, designed for increased speed and sensitivity to thrombus and blood flow. DocWire News spoke with Adam Elsesser, president and CEO of Penumbra, to learn more about this novel system and how it can advance patient care. 📺 Watch Now: https://buff.ly/3RTg4oe
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Congrats to our #client Penumbra, Inc. on the FDA clearance of Lightning Flash 2.0. Check out this video from DocWire News where President and CEO Adam Elsesser talks about how this new computer assisted vacuum thrombectomy (CAVT) system can advance patient care in the treatment of blood clots. #SuccessfulTogether #MedDevice #MedTech #HealthcareInnovation #healthcareagency #healthcarecomms #healthcaremarketing
🆕 Penumbra, Inc., the world’s largest #thrombectomy company, recently announced the US Food and Drug Administration’s clearance of Lightning Flash 2.0, a next-generation, computer-assisted, vacuum thrombectomy (CAVT) system to remove venous thrombus and treat #pulmonaryembolism. Lightning Flash 2.0 features advanced Lightning Flash algorithms, designed for increased speed and sensitivity to thrombus and blood flow. DocWire News spoke with Adam Elsesser, president and CEO of Penumbra, to learn more about this novel system and how it can advance patient care. 📺 Watch Now: https://buff.ly/3RTg4oe
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Great to speak with Richard Curran today on RTE's The Business about Nutriband Inc. (Nasdaq: NTRB) and how we are developing our #AVERSA technology to tackle the complicated opioid crisis. Nutriband listed on the Nasdaq in October 2021 and since then the entire team has been laser focused on taking our #AVERSA technology through clinical development as we aggressively target Q1 of 2025 to file for approval. AVERSA™ Fentanyl has the potential to be the first and only abuse deterrent patch approved anywhere in the world and is estimated to have the potential to reach peak annual US sales of $80 million to $200 million, according to a market analysis report from Health Advances. https://lnkd.in/ep2Niv7V #irishbusiness
Gareth Sheridan
rte.ie
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Learn how a sponsor ensured patient supply while limiting drug overage in a high site / low patient #clinicaltrial with Calyx IRT Advanced Trial Supply Management. Read the case study. https://lnkd.in/gYJE_pVB #IRT #RTSM #Randomization #TrialSupplyManagement #ChooseCalyx #IRT #RTSM #clinicalresearch #DiscoverCalyx
Optimizing Supplies with Calyx IRT: Ensure Patient Supply while Limiting Buffer
calyx.dsmn8.com
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