Ligence’s Post

Excerpt from AAMI nexUS 2024 meeting where Dr. Shuren from the FDA spoke about Standards, and the ASCA effort. Acertara is the only FDA ASCA accredited laboratory for ultrasound testing. "Right now, the Accreditation Scheme for Conformity Assessment (ASCA) is an important opportunity for manufacturers. Dr. Shuren described ASCA as a “highly valuable program,” which is voluntary and meant to “leverage the international conformity assessment structure.” As of 2023, the program is permanent and relies heavily on voluntary consensus standards and functions as a “build out” of CDRH’s work with standards. Dr. Shuren touted ASCA’s benefits, such as dramatically reduced time needed for conformity assessment, certainty regarding what documentation is needed, and improved testing quality. So far, ASCA has enjoyed noteworthy success, and per Dr. Shuren, medical device sponsors are strongly encouraged to participate." 

Check out this virtual workshop from RAPS Western Canada Chapter if you've got questions about transitioning your Class D IVD to be compliant with IVDR requirements.

🎉 FDA cleared ! Not one application but two ✌ . We've just received FDA clearance for two of our groundbreaking products: CINA-iPE, triage tool for incidental Pulmonary Embolism detection, has been granted FDA clearance, along with our quantification tool for automatic ASPECT Scoring, CINA-ASPECTS, marking our first CADx product. "The validations and multi-reader-multi-case studies we conducted highlighted that CINA-ASPECTS not only obtained outstanding standalone performance, but also demonstrated that its adjunctive use significantly improved clinicians’ accuracy in the assessment of ASPECTS regions, compared to the conventional use of NCCT images alone," says our Clinical Affairs Manager, Yasmina Chaïbi. We extend our heartfelt congratulations to the entire team of Avicenneers for their hard work and dedication in making this achievement possible.💪 💼 Both CINA-iPE and CINA-ASPECTS are now available in the US market 🇺🇸, bringing us one step closer to transforming patient care on a global scale. To read the full press release, click on the following link. 📰👉https://bit.ly/3TwWmOX Join us in spreading the word about this groundbreaking news! Together, let's continue to make waves in the healthcare industry and drive positive change for patients worldwide. #FDAclearance #HealthcareInnovation #AvicennaAI #PatientCareRevolution #inavicennawetrust #weareavicenneers #ASPECTS #iPE #ASPECTScore #PulmonaryEmbolism #IncidentalFindings

Are we unfairly holding the drug industry to standards that most NATO countries don't apply for their defense contributions? Read my latest column in #PharmaceuticalCommerce.

Join us July 10 at 9am PT for our next virtual event! If you've got questions about how to transition your Class D IVD to be compliant with the IVDR, this workshop is for you! Join Stefan Burde as he discusses the scope of the IVDR, proposed extensions, and key considerations for Class D devices to enable a smooth transition. Register for this exciting event now! https://lnkd.in/gpgJWDuJ #ivdr #ivd #raps

The insight from BGMA CEO Mark Samuels on the current medicines shortages is a clear call to action. Facing over 100 medications in shortage isn’t just a statistic; it’s a daily challenge for those in primary care and a real concern for patients awaiting treatment. Such shortages can increase NHS costs exponentially due to the need for alternative therapies and the administrative burden of managing these deficits. They also impact patient care, leading to delays and potential compromises in treatment effectiveness. At Valihealth, we understand the gravity of this issue. It touches every facet of primary care, from GPs and pharmacists to the patients they serve. We’re committed to being part of a proactive solution that supports the healthcare system’s stability and ensures that essential medications are accessible when needed. Reach out to learn how we’re tackling this critical challenge.

Check out the latest news about the new #IVDR #NotifiedBody in Italy. You can find all the details in our post, and for more information on the designation scope, follow this link 👉https://lnkd.in/dAV9_KmG

Swissdamed’s Actors Module is live, and Switzerland is aligning with EU IVDR amendments! See how these updates are transforming medical device regulation! https://lnkd.in/ebkZ7EAD #swissdamed #EUIVDR #EUDAMED #MedQAIR

This past weekend’s discussion at the #ApsenIdeasFestival on GLP-1s is now live on YouTube. The panel highlights GLP-1s as generational breakthrough medications with positive health and longevity impacts beyond diabetes and weight loss. They explore the potential of a Netflix model (subscription) for access, addressing healthcare challenges by using these drugs preventatively. Check out the discussion here: #GLP1s #NetflixModel

If you were able to attend, you would have found out the true and authentic meaning of the word #Novel, as it pertains to a device/idea/solution etc in #Startups generally, but, in my opinion #MedTech, specifically.