Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD). The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during cardiac surgery. JuxtaFlow uses a unique, gentle negative pressure technique on the kidneys’ urine-collecting system. It enhances function and shield against hypoxia-induced […]
Align Technology announces $150M repurchase program
Align Technology (Nasdaq:ALGN) announced today that it plans to repurchase $150 million of its own common stock. The open-market repurchase falls under the company’s $1 billion stock repurchase program approved in January 2023. Align Technology executed a $250 million repurchase in February 2023 with Citibank. In October, the company triggered another $250 million repurchase in an […]
LivaNova says cybersecurity breach included personal info for U.S. patients
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 […]
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 […]
ResMed sees increased sleep device demand, stock rises on Q3 beats
ResMed shares ticked up after hours on third-quarter results that came in ahead of the consensus forecast. Shares of RMD rose more than 4% to $191 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day down 1%. The San […]
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 […]
Fresenius Medical Care recalls more than 2 million catheter components
The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind. Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March […]
BD warns on some neXus V700 infusion pumps outside the U.S.
BD issued an urgent field safety notice in the UK to warn of potential issues with its Alaris neXus V700 infusion pump system. According to the notice, BD identified that the anti-free flow clamp may not activate when the system door opens. This allows for the potential uncontrolled flow of medication. The issue does not […]