Coauthor @coauthor_app
Kickstart your compliance. Let us Coauthor with you on your SaMD project so you can be audit ready from day 1. coauthor.app Joined February 2024-
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Exciting innovation!🎉 @nanowearinc's #AI-enabled #SaMD #SimpleSenseBP has recently received #FDA 510(k) clearance for continuous, non-invasive, cuffless blood pressure monitoring. 🌡️ Read more here 👉 medicaldevice-network.com/news/nanowears… #HealthTech #MedTech #Compliance #Digitalhealth
Revolutionary partnership 🤝 between @DeepHealthEU and Incepto will see the creation of a new AI-driven #radiology 🩻 software, expanding access to #AI solutions for healthcare providers. Read more here 👉 medicaldevice-network.com/news/deephealt… #HealthTech #Compliance #Digitalhealth #SaMD
With the aim of enhancing patient care at home, @UniklinikEssen is taking a step toward their “Smart Hospital” 🏥 strategy. They will be remote monitoring patients with pneumonia using the @Luscii1 #SaMD app.📲 Read more here 👉prnewswire.com/news-releases/… #MedTech #Digitalhealth
Recently @dawnhealth_ and @Novartis launched Ekiva PNH - a digital solution📱 for people with Paroxysmal Nocturnal Hemoglobinuria (#PNH). #EkivaPNH includes symptom tracking, medication reminders💊 and care support. Read more here 👉 pages.dawnhealth.com/ekiva-pnh-has-… #HealthTech #SaMD
Amazing to see that @lucemhealth released #RevealforStroke - a pioneering solution aimed at identifying undiagnosed atrial fibrillation (#AFib) patients who are at higher risk of strokes. 📈 Read more here 👉 lucemhealth.com/press-releases… #HealthTech #MedTech #Digitalhealth #SaMD
Congrats to @stethophone_app for their groundbreaking #SaMD! The Stethophone™ transforms smartphones 📱 into medical-grade #stethoscopes🩺 enabling users to capture, analyse, and share #hearthealth data remotely. Read more here 👉 prnewswire.com/news-releases/… #MedTech
Great news that @PrenosisInc and @Roche teamed up to distribute the #sepsisImmunoScore™ across U.S. hospitals. 🏥 This is the first #FDAapproved AI diagnostic device for #sepsis! Read more here 👉 prenosis.com/news/prenosis-… #HealthTech #MedTech #Compliance #SaMD
In the overview of the #DigitalHealth Progress Report📑by @IDTechEx they state that the key to Digital Health is software, & that significant progress has been made in bringing #SaMD to market. Read more👉prnewswire.com/news-releases/… #HealthTech #MedTech #Compliance
Well done👏 Alex Therapeutics and Vicore Pharma for receiving Breakthrough Device Designation status by the FDA for Almee™ (a digital #CBT treatment for anxiety related to PF). Read more here 👉 alextherapeutics.com/post/almee-rec… #HealthTech #MedTech #Compliance #Digitalhealth #SaMD
Study confirms MAGENTIQ-COLO™ (by @MagentiqEye) #AI-aided Colonoscopy Technology Improves Adenoma Detection Rates - potentially helping to save the lives of people with #ColorectalCancer. 👏 Read more here 👉 magentiq.com/lancet-publish… #HealthTech #MedTech #Compliance #SaMD
It's great that the UK has Approved Bodies to certify #MedicalDevices. We think that they should aim to add more specialist notified bodies for SaMD/#AI to help #SaMD startups. 💻 Read more here 👉 gov.uk/government/new… #HealthTech #MedTech #Compliance #Digitalhealth
The #AI-Powered Prenatal #Ultrasound Reporting and Practice Management Solution from Sonio, has officially launched in the USA! 🤰 Read more about how Sonio are addressing the disparities in maternal care here👉 sonio.ai/en/blog/dispar… #HealthTech #MedTech #Compliance #SaMD
This body composition🚶analysis solution analyses quantified #data from CT images to predict and prevent various metabolic diseases. Check out DeepCatch from @medical_ip here👉 medicalip.com/DeepCatch/ #HealthTech #MedTech #Compliance #Digitalhealth #SaMD #AI
See how @Healthyio1 use colourimetric analysis, computer vision, and #AI to transform the smartphone camera into a clinical-grade #MedicalDevice.📱 Learn more here 👉healthy.io/eu/services/ki… #HealthTech #MedTech #Compliance #Digitalhealth #SaMD #CKD
Read how @ultromics secured 4 FDA clearances & two FDA Breakthrough Designations in just 4 years!✅ Hear their story and learn what’s next for AI-driven echocardiography by reading their article👉ultromics.com/articles/ridin… #HealthTech #MedTech #Compliance #Digitalhealth #SaMD #AI
📣Interested in Software as a Medical Device (#SaMD) news and information? Follow our page to stay in the loop with all things SaMD and Compliance. Visit our page then click the follow button👉 x.com/coauthor_app #HealthTech #MedTech #Compliance #Digitalhealth
Congratulations🎉@Tidepool_org, for receiving FDA Clearance for Tidepool Loop! This fully #interoperable & open source diabetes management solution is fast tracking #diabetes management innovation for everyone. tidepool.org/blog/tidepool-… #HealthTech #MedTech #Compliance #SaMD
Great to hear the regulatory environment for #MedicalDevices is being strengthened:✅ "...ensure device regulation is fit for purpose taking into account the diversity of users of #AI and other software as a medical device...."📋 gov.uk/government/new… #Compliance #SaMD
🤗We are excited to be exhibiting at the #MedTech Innovation Expo this year on 5-6 June @thenec! One of the UK & Ireland's leading events for medical device and #SaMD📱manufacturing. Thanks for the shout out @medtechonline📣 #HealthTech #Compliance #Digitalhealth #MedTechexpo
🤗We are excited to be exhibiting at the #MedTech Innovation Expo this year on 5-6 June @thenec! One of the UK & Ireland's leading events for medical device and #SaMD📱manufacturing. Thanks for the shout out @medtechonline📣 #HealthTech #Compliance #Digitalhealth #MedTechexpo
Top 4 strategies on how to avoid Regulatory Debt as a #SaMD startup. 👨💼Our Technical Director gives his top 4 tips on how to avoid regulatory debt as a startup. Read the full article here 👉coauthor.app/blog/navigatin… #HealthTech #MedTech #Compliance #Digitalhealth #startup
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