midge medical GmbH’s Post

...and here is how to briefly present a FIRST, the first mini-oscillometer, a revolutionary diagnostic device !... in French... ..MGC Diagnostics International, MGC Diagnostics, Restech - Respiratory Technology

We're still riding the wave of Guilford Street Laboratories' (GSL)FDA Breakthrough Designation success! For the GSL team, securing Breakthrough Designation for their proteomic Parkinson’s diagnostic, PD Predict, wasn’t the finish line – it was the starting point. With help from Hardian, GSL's newfound access to FDA resources is helping them map their path to pre-market approval and accelerate product development. This designation has offered them the opportunity to refine their strategies, ensuring PD Predict aligns with the highest regulatory standards. This has led to a sharpened focus on optimising timelines and building a strong foundation for success. Need a partner for your FDA submission? Get in touch ➡️ https://lnkd.in/ecUMAN9t

Attending BIOMED ❓ MEDTECH SME team will be attending ❗ 📞 Please contact us to set a meeting if you have any questions. #MDR #FDA #CEMARK #Regulation #Marketapproval #medicaldeviceregulation #PMS #PMCF #510K #PMA #breakthroughtechnologies #clinicalinvestigation #clinicaltrial

We are back with 'Lessons from the SV95C qualification Series'. In 2023, Sysnav and its partners qualified SV95C, the first digital primary endpoint to the European Medicines Agency (EMA). In the next few months, we'll share our biggest takeaways from the qualification. 🤝 Lesson 2: It takes a village Creating meaningful endpoints requires interaction between physicians, engineers, patient associations, and regulators.  Digital endpoints should be: 👉 Meaningful for patients 👉 Used by clinicians 👉 Trusted by regulators The SV95C EMA qualification is the result of collaboration with University of Oxford, Roche, Parent Project Muscular Dystrophy, Muscular Dystrophy UK, World Duchenne Organization, and many others.

🎄 LDTs for the Holidays? Well, sort of... 🎄 Association for Diagnostics & Laboratory Medicine just launched an accredited online course on LDTs and the upcoming changes to FDA oversight. The course covers everything you need: planned regulatory updates, what to expect, and how to prepare for what's ahead. ✨ And here's the best part: it's FREE for ADLM members! ✨ Wishing everyone a happy holiday season. https://lnkd.in/gFvrzNME

Can you protect your priceless pharma and life sciences products — from shipment through delivery? If you’re headed to BSMA in Brussels, come learn how Tive protects your precious life sciences shipments in real time — including dry ice and cryo deliveries — by monitoring real-time shipment location, temperature, humidity, shock, and light exposure. Come say hi to the Tive Team meeting Alex Guillen, Maxence Favre-Verand and myself.

CILIATECH - Glaucoma Innovators has established a new key opinion leader (KOL) advisory board. The seven-member board will help bring the Intercil Uveal Spacer – the company’s new cilioscleral inter-positioning device (CID) for #glaucoma – to market. Read more 👉 https://ow.ly/CuqG50UeFUm

Can you protect your priceless pharma and life sciences products—from shipment through delivery? If you’re headed to BSMA Europe in Brussels, come learn how Tive protects your precious life sciences shipments in real time—including dry ice and cryo deliveries—by monitoring real-time shipment location, temperature, humidity, shock, and light exposure. Come say hi to Tive team Alex Guillen, Dennis Perjet and myself.

𝐃𝐨𝐧'𝐭 𝐦𝐢𝐬𝐬 𝐭𝐡𝐞 𝐥𝐢𝐯𝐞 𝐝𝐞𝐦𝐨𝐬 𝐨𝐟 𝐋𝐔𝐍𝐀 𝟑𝐃 𝐚𝐧𝐝 𝐑𝐚𝐝𝐂𝐚𝐥𝐜 𝐚𝐭 𝐒𝐅𝐏𝐌 𝟐𝟎𝟐𝟒! Visit us at 𝐛𝐨𝐨𝐭𝐡 𝟏𝟑 to experience live demos of our latest innovations and solutions for radiation therapy: LUNA 3D and RadCalc. 🌟𝐋𝐔𝐍𝐀 𝟑𝐃 - Surface Guided Radiation Therapy (SGRT) system to support reproducible patient positioning and monitor patient surface motion at LINAC and CT. 🌟𝐍𝐞𝐰 𝐑𝐚𝐝𝐂𝐚𝐥𝐜- Where precision meets simplicity. The new RadCalc is designed to enhance workflow efficiencies across all phases of the patient QA process. Don't miss your chance to schedule a personal demo and dive deeper into these advancements. We're excited to meet you in person! LUNA 3D has FDA 510(k) clearance. Availability of products, features, and services may vary depending on your location. #SFPM2024 #laplaser #RadiationTherapy #MedicalPhysics #Innovation #PatientCare #radonc #RadCalc #SGRT #LUNA3D

Flow can listen to multiple speakers and remember the information each has shared based on their voice. Watch this example medical screening demo, where Flow even converts the units at the end... Experience Flow today at https://ow.ly/xj6O50SVH55