Avania’s Post

The FDA recently granted authorization to LumiThera, Inc., allowing the company to market its Valeda Light Delivery System. This approval, made under the De Novo authorization pathway, makes Valeda the first FDA-authorized device to treat vision loss in patients with dry AMD. I had the opportunity to speak with LumiThera President and CEO Clark Tedford to learn more about the Valeda technology, its role in the dry AMD market, and the company’s commercialization plans. https://lnkd.in/g28Q9Wxy Eyewire+

📱 Medtronic gets FDA approval for Simplera CGM, partners with Abbott Simplera is the company’s first disposable, all-in-one CGM, measuring half the size of its previous CGMs, and is designed to simplify the insertion and wear experience. Medtronic said the Simplera platform features its latest CGM form factor, and comprises Simplera CGM, used as part of a Smart MDI system. Simplera CGM is used with the InPen smart insulin pen and the Simplera Sync sensor, which is designed to be combined with the MiniMed 780G system. Read more online: https://lnkd.in/eAPjp-7D 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

A Knoxville-based medical-device company, Novoxel – Forward in Motion has launched two new Tixel devices this year + received FDA clearance. Within two years, Novoxel has sold 600 Tixel devices globally, which is unheard of in the aesthetic medical device space. What's the start-up's secret? ⤵ Read out interview with Lee Pannell. Novoxel Feature: https://lnkd.in/epWitGgV Tixel 2 Feature: https://lnkd.in/e9Z8Fqj4

Excited to share insights from Dr. Shikha Barman's presentation: "Successes and Challenges in Establishing Q2/Q3 Similarity for Complex Generic Products." Delve into the detailed process of achieving Q2/Q3 similarity with two case studies: an ophthalmic suspension and a microsphere-based injectable product. Learn about the critical role of Q3 product characterization in ensuring therapeutic equivalence and product performance.

Zenflow, Inc., a South San Francisco, CA-based medical device company developing a minimally invasive treatment for urinary obstruction caused by enlarged prostate, or benign prostatic hyperplasia (BPH), closed a $24m financing round. The company intends to use the funds for Pre-Market Approval (PMA) submission and preparation for commercialization upon FDA approval of its Spring® System. #ZenflowInc #MedicalDevices #MinimallyInvasiveTreatment 

CYROLITE is one of the only polymers which has reliability record spanning more than 40years. #CYROLITE #MedicalDevices #PolymerInnovation #HealthcareSolutions #Reliability #IndustryLeadership #MedicalTechnology #LongTermPerformance #QualityMaterials #EngineeringExcellence

🏥 Cordis wins FDA approval for Mynx Control Venous VCD The approval allows Mynx Control Venous for procedures involving access sites from 6F to 12F. The VCD expands Cordis’ portfolio of extravascular closure devices, intended to deliver predictable deployment and ease of use. It utilises GRIP TECHNOLOGY, based on hydrophilic, bioinert polyethylene glycol (PEG). This allows the VCD sealant to offer a resorption rate that is three times faster than collagen-based sealants. Read more online: https://lnkd.in/g_S459hq 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

Let's go 🚀 Miriam Schulze and Deniz Kaytan are ready to meet you at PharmaForum 2024 in Saarbrücken. Get to know them, our platform MedicalOne Connect and YOOme as your partner for the entire medical device journey. #medtech #digitizepharma #yoome #pharmaforum2024

Dry eye device approval news from Market Scope: Israel’s Novoxel – Forward in Motion announced Nov. 19 that the US FDA had granted 510(k) clearance to the Tixel i treatment device for evaporative dry eye and meibomian gland dysfunction. The company said the device treats upper and lower eyelids of both eyes in less than 2 minutes. #dryeyedisease #MGD #device #FDAapproved #treatment

Advanced Sterilization Products, in collaboration with PENTAX Medical, a division of HOYA Group, proudly announces the FDA clearance of the new ULTRA GI™ Cycle in its flagship product, the STERRAD™ 100NX Sterilizer with ALLClear™ Technology. The ULTRA GI™ Cycle is specifically and uniquely designed to reprocess duodenoscopes using hydrogen peroxide gas plasma sterilization. The FDA clearance marks a significant milestone in advancing patient safety and addressing the challenges associated with current reprocessing methods for duodenoscopes. This groundbreaking sterilization cycle is set to revolutionize sterilization practices in healthcare facilities, ensuring a new standard of safety and efficacy. Learn more about the ULTRA GI™ Cycle by reading the press release now: asplink.co/ultra-gi-cycle #AdvancedSterilizationProducts #PressRelease #NewProduct #SterileProcessing #InfectionPrevention