LivaNova provided additional info regarding a cybersecurity incident first brought to light in late 2023. In November, the company disclosed a cybersecurity breach that disrupted portions of its information technology systems and business operations. This incident came shortly after another large medtech company, Henry Schein, experienced a significant breach as well. London-based LivaNova now says […]
Software / IT
Blue Arbor wins FDA breakthrough nod for neuromuscular interface
Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system. The FDA also accepted the system into its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread […]
FDA clears Epitel remote monitoring tech, AI detection platform
Epitel announced today that it received FDA 510(k) clearance for two new patient-focused brain health offerings. The FDA cleared the Remi remote EEG monitoring system for ambulatory use and the Remi Vigilenz AI for event detection. Remi for ambulatory use allows for EEG recording in outpatient and home environments for an extended duration. Vigilenz AI […]
Exo adds AI-powered cardiac, lung apps to handheld ultrasound
Exo announced today that it launched its FDA-cleared cardiac and lung AI applications for the Iris handheld ultrasound device. The company now has FDA clearance for five different applications on Iris — cardiac, lung, bladder, hip and thyroid. It expects to double that number by 2025. Iris delivers high-performance medical imaging at a fraction of […]
GE HealthCare adds MIM Software to Elekta collaboration
GE HealthCare announced today that it expanded its relationship with Elekta with more collaboration on software for radiation oncology. Together, the companies aim to accelerate innovation in software to improve workflows, increase throughput and enhance user experience. They expect to enable greater precision in radiation therapy treatment with less time at the hospital for patients. […]
GE HealthCare launches new AI-enhanced ultrasound for women’s health
GE HealthCare announced today that it launched the Voluson Signature 20 and 18 ultrasound systems for women’s health imaging applications. Chicago-based GE HealthCare designed the systems to integrate AI, advanced tools and an ergonomic design. They speed exam time for clinicians while delivering a clearer picture of various conditions impacting women’s health. The latest systems […]
Medtronic unveils new AI for laparoscopic, robotic surgery tech
Medtronic today announced new AI capabilities to go with the launch of its Touch Surgery Live Stream digital offering. The medtech giant’s 14 new AI algorithms enhance its digital capabilities within post-operative analysis. Medtronic said they provide AI surgical insights across laparoscopic and robotic-assisted surgery. Along with the algorithms, Medtronic launched its Touch Surgery Live […]
Spark Neuro names Mayo Clinic neurologist as its medical director
Spark Neuro announced that it appointed longtime Mayo Clinic neurologist Dr. Richard J. Caselli as its new medical director. Caselli spent 35 years at the Mayo Clinic, a leading U.S. hospital system. He brings expertise and leadership in neurology and cognitive aging to Los Angeles-based Spark Neuro. Spark Neuro develops brain health assessment services propelled […]
Allurion closes $48 million financing
Allurion (NYSE:ALUR) announced today that it closed a financing of convertible senior secured notes worth $48 million. The company entered into the financing with certain entities managed by RTW Investments. It intends to use proceeds to repay obligations under its existing term loan with Fortress Credit Corp. This reduces the company’s interest expense and increases […]
Osso VR launches medical training app for Apple Vision Pro
Osso VR announced today that it launched Osso Health, a medical training app for use on the Apple Vision Pro system. The offering leverages the power of Apple Vision Pro to blend digital content with the physical world. Osso VR aims to bring the operating experience to live through detailed, clinically accurate workflows of common […]
Dexcom, MD Revolution partner to integrate CGM into remote care platform
MD Revolution today announced a partnership with Dexcom to integrate CGM into its remote care management platform. Dexcom develops continuous glucose monitoring technology (CGM), including its latest-generation G7. The system pairs with smartphones — and now Apple Watches — to monitor the glucose levels of people with diabetes. MD Revolution’s remote care management platform integrates […]