Medical Device Developments

🧙♂️ Synchron - Rodney uses The Force to feed his dog Rodney is living with ALS, he's redefining independence using the Synchron brain-computer interface (BCI) + NVIDIA Holoscan + Apple Vision Pro. In this mind-blowing demo, Rodney controls a bunch of devices around the home using his thoughts —adjusting lights, turning on a fan, and even feeding his dog Piper hands-free, voice-free, and touch-free. By combining Synchron’s BCI tech with NVIDIA’s real-time AI computing, and Apple Vision Pro we’re witnessing the future of human-machine interaction. Video courtesy of Synchron 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🖥️ Sibel Health secures FDA approval for ANNE One platform The FDA approval includes alarms and alerts, alongside a central station, and makes ANNE One align with the IEEE SDC 11073 standard. In addition to the approval, the company has secured $30m in new equity financing, led by existing investors Steele Foundation for Hope and Dräger Steele, which previously led Sibel’s Series B round, contributed an additional $20m, while medical and safety technology firm Dräger added $10m to its previous Series A investment. Sibel plans to use the funding to deploy its platform, which features advanced wearable sensors for wireless monitoring of vital signs in patients aged 12 and older. Read more online: https://lnkd.in/et7nqh-a 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🍋 GE HealthCare unveils AI-powered Invenia ABUS Premium for breast cancer screening The new system is designed to enhance breast cancer screening, particularly for patients with dense breast tissue. It aims to optimise scanning efficiency and support early detection efforts by streamlining imaging procedures and accelerating clinical workflows. The ABUS Premium integrates AI-powered Verisound tools, including Scan Quality Assessment, which enables immediate evaluation of breast coverage and positioning during the exam. It also features Auto Nipple Detection, ensuring consistency in nipple marker placement. A Fast Scan function increases scanning speed by up to 40% compared to its predecessor, Invenia ABUS 2.0, while the cSound Imageformer technology enhances image clarity by automatically adjusting focus at every pixel. Read more online: https://lnkd.in/eVB59qsR 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🖋️ Medtronic reports improved glycemic control with Smart MDI system in real-world study The study analysed data from 1,852 individuals with type 1 diabetes across Europe. It found that those who acted on more than 75% of missed dose or high glucose alerts achieved an average Time in Range (TIR) of 67.2% and 71.5%, respectively. The findings highlight the potential of the Smart MDI system, which integrates the InPen smart insulin pen with the Simplera continuous glucose monitoring (CGM) sensor. The system is designed to help individuals using multiple daily injections (MDI) manage their glucose levels more effectively. Although automated insulin delivery (AID) systems are recognised as more effective, MDI remains widely used due to accessibility and personal preference. The study reported an overall mean TIR of 55.7% among participants, with improved outcomes linked to engagement with system alerts. Read more online: https://lnkd.in/erdrQKns 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🦷 Medit and Pearl partner to enhance AI-powered dental diagnostics This integration aims to enhance intraoral scanning by combining Medit’s precise imaging technology with Pearl’s AI expertise. The partnership is set to improve diagnostic accuracy in dental practices and facilitate more effective communication with patients about their oral health conditions. The Medit Link platform serves as a centralised system for dental clinics and laboratories, designed to streamline digital workflows, from intraoral scanning to patient communication. With Pearl’s AI-powered diagnostics, dental professionals can now identify oral conditions such as teeth misalignment, cracks, calculus, and discolouration more efficiently. This integration promises to standardise diagnostic processes, boosting patient confidence and encouraging necessary treatments to improve oral health. Read more online: https://lnkd.in/eVWPsf4K 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🧠 Synchron unveils roadmap to Cognitive AI with Chiral brain model The company is advancing BCI from supervised to self-supervised learning by integrating large-scale neural data with NVIDIA’s AI-powered computing capabilities. Synchron showcased its AI-enabled BCI, powered by the NVIDIA Holoscan platform, on the Apple Vision Pro at the GTC 2025 event. The technology allows users to control digital and physical environments using Synchron’s Stentrode direct thought-control technology. Synchron CEO and founder Tom Oxley said: “We are building a brain foundation model using generative pre-training techniques that learn directly from neural data—abstracting human cognition at its source – to create features that improve our user’s lives. “This is possible because of our ability to scale large datasets, by making BCI as common as a stent insertion.” Read more online: https://lnkd.in/ePgeneKE 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🦿Orthofix obtains FDA and CE mark approvals for TrueLok Elevate system TrueLok Elevate system is designed to provide limb preservation treatment for bony or soft tissue deformities, including diabetic foot ulcers. The bone transport system aims to address the high incidence of amputations due to diabetic complications. TrueLok Elevate is said to be the first dedicated TBT system to receive FDA approval and is currently commercialised in a limited market release in the US and selected international markets. According to Orthofix, TrueLok Elevate has the potential to be a life-saving, limb-preserving, and cost-effective solution for this patient demographic. The TBT system is part of the medical technology company’s TrueLok family, which includes the TrueLok EVO and TL-HEX ring fixation systems. Read more online: https://lnkd.in/emkN9Dxh 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🌜Moon Surgical expands AI capabilities of Maestro System with NVIDIA The integration of advanced AI technologies will enable the Maestro System to perceive, understand, and interact with its environment, moving beyond conventional robotic assistance. This development aims to facilitate real-time interpretation and adaptation of surgical workflows, thereby optimising efficiency within the surgical ecosystem. The Maestro System utilises the NVIDIA Holoscan platform for real-time sensor processing, supported by NVIDIA IGX. By incorporating NVIDIA’s specialised Isaac for Healthcare, Moon Surgical aims to design, test, and implement intelligent features on the Maestro System more effectively and safely. Read more online: https://lnkd.in/e86tYEyi 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

📄 Your Guide to Navigating FDA & MDR Submissions: Join Cormica® Medical Device & Pharmaceutical Testing Live Webinar Next Week Join expert Elena Henderson as she shares key insights on regulatory expectations, submission strategies, and best practices for ensuring compliance with FDA & MDR biocompatibility requirements. The session will conclude with a live Q&A where you can get answers to your specific questions. With laboratories in the UK, EU and USA, Cormica is proud to offer the most comprehensive testing service ranges for medical devices, pharmaceuticals, and combination products, enabling manufactures to launch and release their products safely and rapidly across the world. Register for the webinar here: https://lnkd.in/egetpTGF 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

💉 Tandem Diabetes Care introduces Control-IQ+ automated insulin delivery in US This advanced hybrid closed-loop algorithm is designed to cater to individuals with type 1 diabetes aged two years and above, as well as adults with type 2 diabetes. The technology is integrated into the t:slim X2 insulin pump and the Tandem Mobi System, with new pumps shipping to customers pre-loaded with the software. Current Tandem customers with in-warranty devices can upgrade to the new software remotely at no additional cost. The Control-IQ+ technology includes several new features to enhance user experience and diabetes management. It supports a broader range of body weights (20-440 lbs.) and total daily insulin requirements (5-200 units), making it more accessible to diverse patients. Read more online: https://lnkd.in/ergH8Uq6 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter