Medtronic issued an urgent field safety notice in Germany to warn of a potential issue with its MiniMed 780G system. MiniMed 780G, Medtronic’s next-generation automated insulin delivery system, has been available in Europe since earning CE mark in mid-2020. In March 2021, the company first communicated that its pumps with software version 6.5 could present […]
State of the industry — Execs ‘more bullish than ever’ on medtech
Ernst & Young’s 2023 Pulse of the Industry medical technology report may not have been overly positive, but medtech executives certainly are. The EY report highlighted sluggish revenues and post-COVID-19 corrections leading to a growth decline. In fact, it was the lowest growth in medtech since 2015. Roughly half of medtech stock price gains realized […]
Report: Boston Scientific to open first China factory in Shanghai
According to reports, U.S.-based medtech company Boston Scientific says it intends to open its first factory in China. Reuters reported that Boston Scientific shared the news in a statement on its WeChat social media account. The report said the company shared its interest in expanding regional production in supply chains. Its factory will be in […]
Philips takes steps to improve health monitoring, care coordination with open ecosystem
Philips today announced interoperability between its Philips Capsule and Philips Patient Information Center iX (PIC iX). Interoperability between the Capsule medical device information platform (MDIP) and PIC iX offers hospitals a first-of-its-kind, comprehensive patient overview. Philips aims to create an open patient monitoring ecosystem, bringing together disparate devices and systems on a single interface. In […]
‘Love, yet fear’ — how medtech is stepping into the digital sphere
Dr. Rajiv Sethi likes to compare the implementation of digital technologies and automation in medtech to the automation in an airplane. If the pilots experienced an issue with their technology or the weather, for instance, they could manually interject, he says. But, the “vast majority of the work” goes down to automation. Sethi serves as […]
FDA grants de novo nod to HistoSonics histotripsy system
HistoSonics announced today that the FDA granted de novo authorization for its Edison system and novel histotripsy therapy platforms. Edison, an image-guided sonic beam therapy system uses advanced imaging and proprietary sensing technology. It delivers non-invasive, personalized treatments with precision and control. The system received FDA investigational device exemption in February. In March, HistoSonics announced […]
Endotronix wins FDA IDE for Cordella pressure-guided therapy trial
Endotronix announced today that the FDA granted it investigational device exemption (IDE) to conduct a study for its Cordella sensor. The study evaluates the use of Cordella in pulmonary artery (PA) pressure-guided therapy. PROACTIVE-HF 2, a prospective, dual-arm trial, aims to expand access for heart failure patients. Endotronix seeks to support efficient and scalable remote […]
WhiteSwell fluid removal system produces positive study results
WhiteSwell announced positive initial results from its DELTA-HF trial evaluating its eLym system for excess fluid removal. Galway, Ireland-based WhiteSwell designed eLym to treat acute decompensated heart failure (ADHF). It presented data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023 in Cleveland, Ohio. The study evaluates the eLym minimally invasive catheter-based […]
J&J’s DePuy Synthes wins FDA clearance for TriAltis tech
Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies. The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling […]
FDA wants more testing in Philips recall
The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips . The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 […]
GE HealthCare launches AI-enhanced point-of-care ultrasound
GE HealthCare announced today that it launched its Venue point-of-care ultrasound systems with AI-driven Caption Guidance. Chicago-based GE HealthCare says the Venue family is the first of its ultrasound guidance to include Caption Guidance. The company added the AI-driven imaging guidance to its arsenal when it acquired Caption Health earlier this year. Caption Guidance, an […]