Biomed Diagnostics, a DCN Dx Brand.’s Post

US MEDICAL DEVICE MANUFACTURING WEEKLY ROUND-UP 💉 💊 Alcon completed the takeover of BELKIN Vision. the $81M deal will allow selective laser trabeculoplasty, an alternative treatment for ocular hypertension and glaucoma, to be manufactured and sold in the US! 🏥 Merit Medical Systems, Inc. acquired Esophyx Z+, a minimally invasive device used to treat gastroesophageal reflux disease, from EndoGastric Solutions worth $105M. The device is expected to add $30M to its annual sales and more importantly, treat the 20% of the US population who suffer from GERD. 👨⚕️ FDA has partnered with Bill & Melinda Gates Foundation in the hope of improving disease detection. The $1.9M collaboration will create new analytical methods to help the development of breath-based diagnostic devices! #Manufacturing #Medical #Medicaldevices #USmedicaldevices #USmedicaldevicemanufacturing #Medicaldevicemanufactruing

☑️ Boston Scientific secures a CE mark for its Deep Brain Stimulation software, aimed at aiding clinicians in programming devices for early-stage Parkinson's disease. ☑️ Medtronic reports positive results from a study on its MiniMed 780G system, showing reduced diabetes burden. ☑️ Alcon obtains FDA 510(k) approval for its Unity VCS and CS systems, which are expected to enhance workflow efficiencies. ☑️ Insulet Corporation plans label expansion for its Omnipod system in type 2 diabetes following positive trial data showing glycaemic improvements. ☑️ Sequel Med Tech received FDA clearance in March for its unique twiist automated insulin delivery system, introducing a novel option in the diabetes management market. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

☑️ Baxter launches its next-gen Vest system for airway clearance, offering an advanced pulmonary experience (APX) for patients with respiratory conditions. ☑️ Vivani receives Australian approval to begin a GLP-1 implant trial, which will assess the safety and pharmacokinetics of its exenatide implant. ☑️ QIAGEN secures EU IVDR certification for its QIAstat-Dx systems and panels, enabling detection of gastrointestinal and respiratory diseases in compliance with European regulations. ☑️ Siemens Healthineers installs its first self-driving mobile C-arm in a U.S. healthcare facility, marking a milestone for automated imaging technology. ☑️ Medtronic’s renal denervation system, Symplicity, is recognized on Fortune’s 2024 “Change the World” list for its impact on blood pressure management. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

🚰 The FDA's TAP program is transforming how AI-powered medical devices are brought to market. We're thrilled to see our friends at Ultromics secure their 6th FDA clearance for EchoGo Amyloidosis - a breakthrough in cardiac diagnostics. 🔬This signals a new era where regulators are actively creating pathways for innovative medical technologies. Smart regulation = faster innovation = better patient care. 💡 See how leading companies like Ultromics are leveraging modern data infrastructure to accelerate medical device development ➡️ https://lnkd.in/e-7KWNnz

Learn how HALO AP Dx automatically organizes images, metadata, gross details, and patient information into cases, facilitates case prioritization and sign-out, and enables ergonomic image navigation. See common anatomic pathology workflows in action and discover how HALO AP Dx modernizes tumor boards and promotes streamlined management of clinical trials.

☑️ Siemens Healthineers secures CE Mark for Alzheimer’s PET analysis with new Centiloid scoring and tau PET quantification features in its syngo.PET software. ☑️ FDA greenlights add-ons for Boston Scientific’s Farapulse field ablation system, including the Farawave NAV catheter and Faraview software for enhanced cardiac ablation procedures. ☑️ Thermo Fisher Scientific's Oncomine receives FDA approval as a brain tumor diagnostic, to identify patients eligible for treatment with Servier’s Voranigo. ☑️ Biofabrication Group firm acquires $1.8 million to advance AI-powered software for 3D-printed medical devices, simplifying the biofabrication process. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Discover the power of flow cytometry technology in IVD (In Vitro Diagnostics) medical devices with this insightful video created by MIT. Learn how flow cytometry enables precise cellular analysis, leading to rapid and accurate diagnostics. This video explores the technology's workings, its applications in medical diagnostics, and its transformative impact on healthcare. Dive into the science behind flow cytometry and see how it’s advancing patient care and outcomes. #FlowCytometry #IVD #RandD #Research #Topvoice #MedicalDevices #Diagnostics #HealthcareInnovation #MedTech #CellAnalysis #Healthcare #MIT

After Johnson & Johnson has doled out more than $30 billion for Abiomed, Laminar, Inc. and Shockwave Medical, are more medtech deals on the way? Despite the brisk pace, the healthcare giant’s spending spree may not be over any time soon. "Our M&A strategy is not going to change. We’ll continue to evaluate opportunities agnostic to the sector and size. When we think about M&A, we think in decades. We don’t think opportunistically." - Joaquin Duato, CEO at Johnson & Johnson. “[Shockwave] will be our third very thoughtful and deliberate move to only participate in high growth, high margin cardiovascular areas, where there is significant unmet need and tremendous opportunity for us to grow." - Tim Schmid, Head of J&J’s medtech businesses. View the full article here: https://bit.ly/3Ua79iy #Medexec #medtech #medtechnews #medicaldevices #mergersandacquisitions

1️⃣ Simpson Interventions has received FDA breakthrough device designation for its Acolyte system, which now qualifies for prioritized review and enhanced feedback from the FDA. 2️⃣ Medtronic's TAVR system demonstrated superior performance in women in the SMART trial, where 87% of participants, typically with smaller aortic annuli, were women. 3️⃣ Roche has earned a breakthrough designation for its Elecsys pTau217 plasma biomarker test for Alzheimer’s, developed in partnership with Eli Lilly, which detects amyloid pathology. 4️⃣ Kalogon has introduced the Orbiter Med, a custom wheelchair cushion that combines its APM system with individualized postural support. 5️⃣ Raydiant Oximetry, Inc. has secured US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) for its Lumerah technology, allowing an early feasibility study on pregnant women during labour and delivery. 🚀 Smarteeva's advanced AI technology, combined with experience and expertise is a game-changer for various medical device companies. Get in touch today: https://lnkd.in/gjYE7UEZ #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

During the Clinical Trials Imaging Accuracy Crisis Panel Discussion at #AACI #CRI2024, Kira Pavlik, Associate Director of Clinical Trials Operations at the Yale Cancer Center, delves into the complexities of FDA inspections and the meticulous processes involved in bringing new drugs to market. Hear firsthand experiences of navigating rigorous reviews, the importance of detailed documentation, and the global impact of ensuring drug efficacy and safety: https://zurl.co/fYoW #clinicaltrials #clinicaltrialimagingworkflow #imagingworkflow #pharma #regulatory