Able Moving & Storage Inc.的动态

MDCG published the Preliminary Assessment Review Template - MDR (EU 2017/745) - MDCG 2024-7 Rev.01 #MedicalDevice #MD #EUMDR #MDCG #Alert #Medtech #MDalert #EU #Globalmedicaldevice #Globalmedicaldeviceregulation

???MDCG 2024-14 26 Nov 2024???Guidance on the implementation of the Master UDI-DI solution for contact lenses. Source: https://lnkd.in/dhZa5xwR #eudamed #medtech #medicaldevices #regulatoryaffairs #regulatorycompliance #EUDAMED?

If you've ever wanted to know more about the #FDA's enforcement discretion for #SaMD and #DTx devices, I've got you covered! Check out our newest resource as I break down how the FDA's enforcement discretion offers an alternative regulatory pathway for certain types of low-risk SaMD/DTx devices, allowing for faster market entry and a phased approach to device development and functionality release. ??Innovation Insights: "?????? ?????????????????????? ????????????????????: ?? ?????????????????? ???????? ???? ???????????? ?????? ?????????????? ???????????? ?????? ?????????????? ???????????????????????? ??????????????????": https://bit.ly/3wUihbC Carrie Nixon Rebecca E. Gwilt Michael Pappas Reema Taneja Kaitlyn O'Connor Sam Pinson Aizaz Chaudhary Stephanie Barnes #enforcementdiscretion #healthtech #healthcareinnovation #digitalhealth

A great recap of Day 1 of the #DTA2024 Summit by my colleague Michael Schellhous. I was pleased to participate on a panel discussing regulatory implications for #DTx business models, along with Jeffrey Abraham, Marty Culjat Acacia Parks PhD, MBA, Aubrey Shick, and Daniel Cody. I'll add the following to Michael's key takeways: * Collecting data to provide clinical evidence of improved outcomes is critical for adoption by clinicians and patients alike. (No surprise here!). This data should include efficacy in addressing #healthequity issues. * #Digitaltherapeutics companies seeking investment should expect to see smaller check sizes than we experienced two years ago, and these companies should be open to a variety of business models. Tanisha D. Hill, PhD, MPH Leanna Fortunato, Ph.D. Kyu Rhee, MD, MPP Andrey Ostrovsky, MD, FAAP Arnold L., Sizi Chen Marko Kuisma

???MDCG 2024-14 26 Nov 2024???Guidance on the implementation of the Master UDI-DI solution for contact lenses. Source: https://lnkd.in/giieF8c9 #eudamed #medtech #medicaldevices #regulatoryaffairs #regulatorycompliance #EUDAMED?

Come join?InMode (#nasdaq: INMD), an MS-IR LLC client, as Yair Malca, Chief Financial Officer, and Spero Theodorou MD, Chief Medical Officer, participate in a fireside chat hosted by Matt Taylor, CFA at the Jefferies Healthcare Conference at 7:30am ET on June 5, 2024 For more details and to register for the live webcast, please click the link in the first comment. #inmode?#inmd?#medtech?#medicaldevices #medicaltechnology #investorconference

Proven across 60K studies, Calyx #CTMS streamlines end-to-end #clinicaltrial management, supporting development programs across all phases, therapy areas, and design complexities. https://lnkd.in/gp5XwWqV #ChooseCalyx #ClinicalTrials

Let’s talk about the features of DTx ?? Since #digitaltherapeutics are mostly software-based products, they’re subject to numerous globally accepted standards and local regulations. #DTx products should comply with principles, including product safety, efficacy, quality, patient centricity, privacy, and ongoing clinical impact. The important feature of DTx features is its personalisation. Medical specialists prescribe tailored applications based on patient needs, preferences, and therapy progress. This helps patients get effective tools for their therapy in a comfortable environment. Swipe right and take a look at other DTx facts ?? #medicalsoftware #digitalhealth #MDR #medicalregulations

RF recently announced the formation of US VisionMed Partners alongside our partners Kian Capital Partners and Lakewood Healthcare Capital. The platform’s locations serve patients with an emphasis on specialty and medical services and products such as exams, diagnostic testing, dry eye treatments, vision therapy and myopia management. #Optometry #MSO #PrivateEquity #MergersandAcquisitions

Edwards Lifesciences says it could grow up to 10% next year. "We have significant opportunities to grow #TAVR and are proud to continue our deep commitment to advancing science and streamlining care for aortic stenosis patients." Associate Editor Sean Whooley has the details on MassDevice. #medtech #meddevice