President Joe Biden’s administration declined to veto an import ban on Apple Watches after the government ruled in favor of Masimo in a patent spat. The long-running battle between companies came to a head last week when Apple paused sales of two models of its smartwatch. This spat centers around light-based pulse oximetry technology used […]
Digital Health
Medtronic has a Class I recall for its surgical navigation software
The FDA deemed the recall of Medtronic StealthStation S8 software Class I, the most serious kind. This recall — a correction, not a product removal — relates to StealthStation S8 Application Version 2.0 and 2.0.1. It affects 2,109 devices distributed in the U.S. between Jan. 7, 2022, and Oct. 2, 2023. Medtronic initiated the recall […]
Apple reportedly stops U.S. sales of certain smartwatches amid Masimo patent spat
Apple reportedly paused sales of two models of its smartwatches in the U.S. as it looks to resolve a patent dispute with Masimo . Apple confirmed the decision in a statement to 9to5Mac. The patent spat goes back as far as January 2020, centering around light-based pulse oximetry technology used by the watches. Masimo develops […]
Luma Vision raises $22M for 4D cardiac imaging, navigation tech
Luma Vision announced today that it raised $22 million to support its bid for FDA clearance of its Verafeye imaging and navigation platform. The company, headquartered in Dublin, Ireland, and Munich, Germany, develops novel four-dimensional (4D) technology. It designed Verafeye for cardiac imaging and navigation and has plans to build next-generation versions for additional applications. […]
FDA clears Masimo Stork home baby monitoring system
The FDA today published a 510(k) premarket notification granting clearance to the Stork baby monitoring system from Masimo . Stork offers a continuous and accurate view of a baby’s health data. It leverages Masimo’s noninvasive neonate monitoring technologies. Masimo’s smart home baby monitoring system officially received its clearance on Dec. 15. The company already began its […]
HeartBeam unveils AI program for cardiac insights
HeartBeam (Nasdaq:BEAT) announced today that it made significant developments in the AI applied to its proprietary ECG technology. Santa Clara, California-based HeartBeam develops its proprietary vectorelectrocardiography (VECG) technology. The company aims to provide diagnostic and prognostic insights about cardiac health beyond what standard 12-lead ECGs provide. HeartBeam’s VECG technology collects 3D signals of the heart […]
Microbot Medical, Corewell collab on telerobotics for endovascular surgical robot
Microbot Medical (Nasdaq:MBOT) announced today that it entered into a collaboration with Corewell Health to enable telerobotic capabilities. The collaboration, separated into multiple phases, seeks to enable telerobotics between remote centers. It aims to do so utilizing the Liberty endovascular robotic surgical system. The Braintree, Massachusetts-based company has plans to submit Liberty for FDA IDE approval […]
Tandem Diabetes Care launches diabetes management platform for insulin pump users
Tandem Diabetes Care announced today that it launched Tandem Source, a diabetes management platform. The platform, for both insulin pump users and healthcare providers, brings together features of Tandem Diabetes Care’s legacy offerings. It combines t:connect, t:connect HCP and t:connect Portal with new, comprehensive data reporting in one central, scalable platform. All Tandem pump users […]
Neuranics is set to launch wearable heart monitor with magnetic sensor tech
Neuranics announced today that it plans to launch a magnetic sensor development kit for monitoring the magnetic activity of the heart. Glasgow, Scotland-based Neuranics designed the kit to record heart activity and wirelessly transfer recordings over Bluetooth. It provides live, 24/7 recording and analysis straight to a smartphone, tablet or laptop. The startup develops magnetic […]
Edwards plans to spin off critical care business next year
Edwards Lifesciences announced today that it intends to spin off its critical care business by the end of 2024. The company shared a number of key plans going forward as it outlined its plans for future growth. Among its plans, Edwards expects to spin off the critical care unit and its full range of smart […]
Kandu Health has positive data for stroke recovery platform
Imperative Care’s Kandu Health today announced positive data supporting its digital post-acute stroke treatment platforms. Campbell, California-based Kandu shared data at two conferences. It presented results from a study of its remote post-acute service at the Society of Vascular and Interventional Neurology (SVIN) Annual Meeting. The company presented feasibility data on its navigation platform at […]