Medical Devices News

DUBLIN--(BUSINESS WIRE)--Mainstay Medical Holdings plc today announced that Blue Cross Blue Shield of North Dakota has established favorable coverage for the company’s ReActiv8 Restorative NeurostimulationTM therapy for the treatment of intractable chronic low back pain. The policy went into effect in January 2026 and specifies that ReActiv8 is the only therapy considered medically necessary by the policy when the conditions for coverage are met. “We are pleased that another Blue Cross Blue Shi...

JASPER, Ind.--(BUSINESS WIRE)--Kimball Electronics, Inc. (Nasdaq: KE) today announced financial results for the second quarter ended December 31, 2025.                 Three Months Ended   Six Months Ended   December 31,   December 31, (Amounts in Thousands, except EPS)   2025       2024       2025       2024   Net Sales $ 341,280     $ 357,392     $ 706,883     $ 731,648   Operating Income $ 10,767     $ 8,230     $ 25,221     $ 17,345   Adjusted Operating Income (non-GAAP) $ 15,308     $ 13,3...

TEMPE, Ariz.--(BUSINESS WIRE)--Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today reported financial results for the fourth quarter ("Q4'25") and year ended December 31, 2025 ("2025"). Q4'25 total revenues were $1,047.6 million, up 5.2% sequentially and up 5.3% year-over-year....

HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced it will report business updates and financial results for the fourth quarter and full year 2025 after market close on Thursday, February 19, 2026. Company management will host a corresponding conference call beginning at 1:30pm PT / 4:30pm ET. Investors interested in...

BOSTON--(BUSINESS WIRE)--WHOOP, the human performance company, today announced that the U.S. District Court for the District of Massachusetts has granted a motion by WHOOP for a preliminary injunction against Shenzhen Lexqi Electronic Technology Co., Ltd. (Lexqi). The injunction, issued in a trade dress infringement lawsuit brought by WHOOP, orders Lexqi to immediately stop selling its infringing wearable product in the United States while the litigation proceeds. WHOOP filed the lawsuit to pro...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Results from a recently published randomized, double-blind, placebo-controlled clinical trial show that supplementation with Brightseed® BioMetaControl, containing the naturally occurring bioactive compounds N-trans caffeoyltyramine (NCT) and N-trans feruloyltyramine (NFT), significantly improved markers of glycemic control in adults with prediabetes. The study was published in the peer-reviewed journal Bioactive Compounds in Health and Disease. In...

LUXEMBOURG--(BUSINESS WIRE)--Eurofins Scientific SE (EUFI.PA) has received various notifications of dealing from Persons Discharging Managerial Responsibilities (“PDMR”). The notification of Dealing Form for each PDMR can be found below. This notification is made in accordance with the European Market Abuse Regulation. NOTIFICATION AND PUBLIC DISCLOSURE OF TRANSACTIONS BY PERSONS DISCHARGING MANAGERIAL RESPONSIBILITIES AND PERSONS CLOSELY ASSOCIATED WITH THEM   1. Details of the person discharg...

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that it has appointed Eric Knudsen as its new Chief Executive Officer, effective April 1. Knudsen will succeed Jon Rennert, who served as ZOLL’s CEO for the past 10 years and will assume a new role as Executive Chairman of ZOLL’s Board of Directors. “As a global leader in medical technology, ZOLL is continually looking for ways to expand our busines...

HOUSTON--(BUSINESS WIRE)--InGeneron, Inc., a biotechnology company pioneering autologous regenerative cell therapies, today announced receipt of a CE Certificate (No. 28620235524 issued January 19, 2026) for the Transpose Ultra® (Sterile Kit) and the Processing Unit (Centrifuge) in accordance with Regulation (EU) 2017/745 on medical devices (the Medical Device Regulation, MDR). Intertek Medical Notified Body AB (2862) conducted an extensive review of the submitted Technical Documentation and pe...

BOSTON--(BUSINESS WIRE)--Eurofins MET Laboratories, part of the Eurofins Electrical & Electronics global network, announces the opening of its new state-of-the-art 60,000-square-foot testing laboratory in Littleton, Massachusetts – a prime location in the Boston innovation corridor. Positioned at the epicenter of New England's med-tech, wireless innovation, clean energy, and advanced electronics ecosystem, the capabilities of this laboratory further position Eurofins MET Laboratories as the...