Posts by cstephenson@legacymedsearch.com
Cochlear and GN Hearing Become Worldâs First to Support Direct Android Streaming to Hearing Devices Using Bluetooth Low EnergyÂ
Collaboration with Google on hearing aid specification now officially brings direct streaming of music, phone calls and other sound to people with hearing loss. For the first time, people can stream sound from their compatible Android devices to their hearing devices using Bluetooth Low Energy. GN Hearing, the global leader in hearing aid connectivity, and…
Read MoreGE Healthcare Receives FDA Clearance of First Artificial Intelligence Algorithms Embedded On-Device to Prioritize Critical Chest X-ray ReviewÂ
GE Healthcare today announced the Food and Drug Administrationâs 510(k) clearance of Critical Care Suite, an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco (UCSF), using GE Healthcareâs Edison platform, the AI algorithms help to reduce the turn-around time it can take for…
Read MoreFDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) SystemÂ
EBR Systems, Inc., developer of the worldâs only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure. The FDA created this designation and its associated program in 2017 for certain devices…
Read MoreBaxter Announces Acquisition of Cheetah Medical to Expand Specialized Patient Monitoring Portfolio
Baxter International Inc., a leading global medical products company, today entered into a definitive agreement to acquire Cheetah Medical, a leading provider of non-invasive hemodynamic monitoring technologies. The agreement demonstrates Baxter’s ongoing commitment to improving clinical outcomes with an established patient monitoring technology to better inform and guide clinicians’ treatment decisions. Cheetah Medical is a…
Read MoreTivus Ultrasound System for Pulmonary Arterial Hypertension Gets FDA Breakthrough Designation
SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients with PAH. âPAH is classified as a life-threatening or irreversibly debilitating disease because it is…
Read MoreAxonicsÂŽ Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation SystemÂ
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable rechargeable sacral neuromodulation (âSNMâ) device for the treatment of urinary and bowel dysfunction, today announced the approval of the Axonics r-SNMÂŽ System by the United States Food & Drug Administration (âFDAâ). The Axonics System is the first rechargeable SNM system…
Read MoreMulti-Sensing Glove Makes Prosthetic Hands More RealÂ
Engineers from Purdue University, University of Georgia, and University of Texas have combined forces to develop a glove that can be put over existing prosthetic hands to give them a more life-like feel and the ability to sense a variety of parameters. The glove is intended to improve a userâs ability to interact with others.…
Read MoreFirst Long-distance Heart Surgery Performed via Robot
A doctor in India has performed a series of five percutaneous coronary intervention (PCI) procedures on patients who were 20 miles away from him. The feat was pulled off using a precision vascular robot developed by Corindus. The results of the surgeries, which were successful, have just been published in EClinicalMedicine, a spin-off of medical…
Read MoreStryker announces definitive agreement to acquire Mobius Imaging & Cardan RoboticsÂ
Stryker (NYSE: SYK) announced today a definitive agreement to acquire Mobius Imaging, LLC, a leader in point-of-care imaging technology, and its sister company, GYS Tech, LLC (DBA Cardan Robotics), in an all cash transaction of approximately $370 million upfront and up to $130 million of contingent payments associated with development and commercial milestones. The acquisition…
Read MorePacemaker-Like Implant Cleared in Europe to Lower Blood Pressure
Orchestra BioMedâ˘, Inc., (âOrchestra BioMedâ or the âCompanyâ), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, announced today that it has received CE Mark approval for its ModeratoÂŽÂ implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy⢠(CNT) for treatment of hypertension while also providing standard pacemaker functions. Additionally,…
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