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 […]
Health Technology
Report: Abbott files trio of patent lawsuits over CGM tech in Europe
Abbott (NYSE:ABT) filed three patent lawsuits against SiBionics and its distribution partner in Europe, JUVE-Patent reports. The lawsuits include patent infringement allegations centered around continuous glucose monitoring (CGM) devices, according to the report. Abbott filed them against China-based SiBionics and its sales partner Umedwings at the Unified Patent Court. SiBionics develops, manufactures and distributes CGM […]
FDA approves Medtronic’s Inceptiv closed-loop rechargeable spinal cord stimulator
Medtronic announced today that it received FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) system. Inceptiv treats chronic pain and represents Medtronic’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the […]
Dexcom stock slides despite Q1 beats, sales guidance increase
Dexcom shares took a hit after hours today on first-quarter results that came in ahead of the consensus forecast on Wall Street. Shares of DXCM dipped about 7% to $128.40 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day […]
BCI maker Science acquires retinal implant from Pixium Vision
Brain-computer interface developer Science Corporation announced today that it acquired the IP and related assets for the Pixium Vision Prima implant. Neuralink co-founder Max Hodak founded Science, which unveiled its Science Eye brain-computer platform in 2022. The Science Eye is a visual prosthesis. It targets retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD), two […]
Philips receives FDA warning letter over imaging systems manufactured in China
The FDA published a warning letter that it sent to Philips that outlines issues around imaging technology manufacturing practices. During an inspection of a manufacturing facility in Suzhou, China, the FDA determined that the devices are “adultered.” The inspection took place from Oct. 23, 2023, through Oct. 26, 2023. Philips received the letter outlining violations […]
FDA says InfuTronix infusion pump recall includes 1 death
The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death. Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues […]
Study highlights benefits of automated insulin delivery for children in UK
A study in the UK demonstrated significant improvements in HbA1c for users of automated insulin delivery technologies. This comes on the heels of a UK NHS initiative to provide tens of thousands of children and adults with type 1 diabetes in the country with an artificial pancreas. The study aimed to assess the efficacy of […]
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 […]
Non-insulin, basal CGM use exceeds analysts’ expectations, Dexcom and Abbott to benefit
William Blair analyst Margaret Kaczor reported surprise at the increase in users of CGM within the non-insulin and basal insulin populations. Kaczor expects Dexcom and Abbott to benefit from the trend with their next-generation CGM offerings after meetings with both companies’ management. Both companies launched next-gen CGMs in recent years (Dexcom G7 and Abbott FreeStyle […]
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 […]