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 […]
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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 […]
4WEB Medical wins regulatory clearance for Anterior Spine Truss System
4WEB Medical this week announced it received regulatory clearance for its Anterior Spine Truss System with Anchor Fixation (ASTS-AF). The Dallas-based orthopedic implant company’s current anterior lumbar implant offering includes a traditional interbody with the option of an integrated plate and a standalone interbody with screw fixation. The regulatory clearance expands the company’s portfolio to […]
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 […]
Edwards Lifesciences beats the Street in Q1 and increases sales outlook
Edwards Lifesciences reported first-quarter results that exceeded Wall Street expectations after market close today. The maker of catheter-delivered heart implants — including transcatheter aortic valve replacement (TAVR) systems and transcatheter mitral and tricuspid therapies (TMTT) — also increased its full-year sales guidance. EW’s stock price was relatively flat in after-hours trading. Irvine, California–based Edwards Lifesciences […]
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 […]
Integer stock sinks despite Q1 beat as full-year forecast disappoints
Integer stock declined by 10% today despite posting Street-beating first-quarter earnings. Investors were likely reacting to the medtech contract manufacturing giant’s full-year guidance, which was less than the analyst consensus. Plano, Texas–based Integer earned $20.5 million, or 59¢ per share, off of $414.8 million in sales for the quarter ended March 29, 2024. Compared to Q1 […]
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 […]