Provista’s Post

Struggling with precise and safe radiopharmaceutical dosing while dealing with limited space and strict regulations? Improving your processes help to cut costs, enhance dosing accuracy, and significantly boost patient safety. This is where traditional manual methods are often inefficient and prone to errors. Join us at EANM in Hamburg to see how our solution, the OVD-system, tackles your challenges head-on. Want to learn more about how and why we developed the OVD system? Follow the link to our Blog and understand our way from concept to a product that solves global challenges. https://ow.ly/Ribz50TNibA #ctsgroup #innovation #radiopharmacy #eanm2024

Our latest blog explores how enhanced tear resistance impacts safety and efficiency in healthcare packaging.

Fiber tear in healthcare packaging can introduce myriad issues. What factors must you keep in mind when optimizing for tear resistance? Take a look at our latest blog entry. #HealthcarePackaging #Amcor

Fiber tear is unacceptable in healthcare packaging, but what can be done to stop it? Learn how and why tear resistance is a key focus area when selecting materials for packaging solutions for everything from medical devices to pharmaceuticals. https://lnkd.in/g6X2Ydb8 #HealthcarePackaging

Learn more about enhanced tear resistance and its impact on preventing fiber tear in our latest blog.

PBC Biomed Case Study: Biomimetic Innovations Ltd – Breakthrough Device Designation, FDA. ◽ The Challenge: Navigating the regulatory pathway for a novel device can be complex and uncertain. Determining the appropriate regulatory classification, understanding the requirements for premarket submissions (e.g., 510(k), PMA), and interpreting FDA guidance documents can pose significant delays and challenges for companies. Additionally, developing and bringing a novel medical device to market requires significant funding, human resource, and time. ◽ The Approach: Following careful review of the device data, PBC Biomed's Regulatory Specialist Vijay Vyas recognized that one of the new technologies it was developing – OsStic®, could qualify for Breakthrough Device Designation. This designation would prioritize the FDA’s review of the regulatory submission for the product, potentially allowing the team to obtain marketing authorization faster than standard review timelines. ◽ The Solution: First Vijay conducted extensive research on the application and qualification criteria for the Breakthrough Device Designation programme. Together with the support of the PBC Biomed Clinical Advisory Board, the indication for the device and potential clinical outcomes for the patient were identified. The extended regulatory team then collated and organised the supplementary information and evidence required to complete the submission. ◽ The Result: OsStic® was awarded Breakthrough Device Designation in December 2023. Read full Press Release here: https://lnkd.in/ek8Zd4px This landmark designation signifies the innovative and potentially transformative nature of the device, which will enhance the marketability and attractiveness of OsStic® to investors, strategic partners, healthcare providers, and patients. If you would you like to explore whether your new technology is applicable for the #BreakthroughDevice programme, contact our team at [email protected] today! *Biomimetic Innovations Ltd is an affiliate company of PBC Biomed. #breakthroughdevice #fda #regulatoryconsulting #pbcbiomed #medtech #acceleratingmedicalinnovation #bioadhesive #noveldevices

A User-Preference Study on an Ophthalmic Injection Device to Facilitate Microliter Dosing for Intravitreal Injections As already presented at the PDA Fair, we're excited to offer you access to our latest study: This comprehensive study dives into current practices, challenges, and unmet needs in the field of intravitreal injections (IVIs). Through extensive research, surveys, and interviews with retina specialists, Gerresheimer has developed a device concept that improves accuracy, reduces procedure time, and enhances patient safety. Download now to explore how this innovation can transform IVI practices. https://lnkd.in/ekP6mZnB For questions and further insights, please reach out to: Dr. Reza Abedian #innovatingforabetterlife #ophthalmology #injection #pharma #patientsafety

Read today's blog to discover several noteworthy trends that are shaping the #laparoscopic market landscape in Western Europe: https://hubs.la/Q02YP1yl0 #medicaldevices #healthcare #clinicalcare #pharma

Elutia CEO Randy Mills shares insights on how the company is driving healthcare innovation with CanGaroo RM, a drug-eluting biologic that can prevent patients from contracting infection from implanted medical devices. Watch full interview here: https://lnkd.in/gMdenAvm #elutia #pacemaker #medicaldevices #biotech #medicalimplants #healthtech

✔️4C Medical Technologies, Inc. announced the FDA granted breakthrough device designation for its AltaValve system. The company received designations for two therapeutic indications for the transcatheter mitral valve replacement device. 👏Saravana Kumar, CEO and President commented: “This advancement enables us the opportunity to bring this needed technology to our patients even sooner.” 🔗Read more: https://lnkd.in/dJjiTFhJ 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dYC56Usw #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #Surgeons #GuidedSolutions