Go-Pen wins CE mark for user-fillable insulin pen
November 11, 2025
Go-Pen announced today on social media that it received CE mark approval for its user-fillable insulin pen.
Go-Pen announced today on social media that it received CE mark approval for its user-fillable insulin pen.
Stereotaxis (NYSE:STXS) announced today that it received FDA 510(k) clearance for its next-generation GenesisX surgical robot.
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received FDA approval for the Android version of its Mobi mobile app
DALLAS, Nov. 6, 2025 /PRNewswire/ — Dallas-based MedCAD has been awarded 510(k) FDA clearance for its AccuStride fixation plates, part of a patient-specific solution available to surgeons as a complete foot and ankle (F&A) system. The company received 510(k) FDA clearance for its foot and ankle guides and planning system in March 2025. The AccuStride implant and surgical guide system coupled with the company’s proprietary planning software will enable foot and ankle surgeons to correct multiple related pathologies in a single procedure.
CAESAREA, Israel, Nov. 6, 2025 /PRNewswire/ — Nitinotes Ltd., a medical device company transforming the treatment of obesity, today announced it has received CE Mark approval for the EndoZip™ System, the first fully automated suturing platform for endoscopic sleeve gastroplasty (ESG). The milestone clearance enables Nitinotes to begin commercialization across the European Union and other CE Mark-accepting markets.
Driven by high-frequency piezo technology, the console enables precise, tissue-sparing bone cutting while protecting nerves, vessels, and soft tissues
Medical Microinstruments (MMI) announced today that it received FDA investigational device exemption (IDE) to study its microsurgery platform
The panels employ PCR techniques to test for numerous gastrointestinal bacterial pathogens using one stool swab.
Aqua Medical has received an investigational device exemption (IDE) from the FDA for its ablation device intended to treat diabetes, the company told MassDevice ahead of an official announcement later today.
SAN DIEGO, Nov. 3, 2025 /PRNewswire/ — The U.S. Food and Drug Administration (“FDA”) has granted QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the “VITROS hs Troponin I Assay”). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).