Bigfoot Biomedical announced today that it received FDA 510(k) clearance for the Android version of its Bigfoot Unity mobile app. The Milpitas, California-based company received FDA clearance for its diabetes management platform in May 2021. Its initial rollout featured compatibility with iOS devices. The first-of-its-kind system includes connected smart pen caps designed to recommend insulin […]
FDA
FDA clears cranial procedure guidance system from Stryker
Stryker (NYSE:SYK) announced today that it received FDA 510(k) clearance for its Q Guidance System with cranial guidance software. Kalamazoo, Michigan-based Stryker designed the Q Guidance System as an image-based planning and intraoperative platform. The company launched the system for spinal applications in September 2022. This latest iteration offers support for cranial surgeries. Q Guidance […]
GE HealthCare recalls scanner for patient crushing risk
The FDA labeled the recall of the GE HealthCare (Nasdaq:GEHC) Nuclear Medicine 600/800 Series systems as Class I, the most serious kind. GE HealthCare recalled the imaging platforms after identifying an issue with two mechanisms. These mechanisms prevent uncontrolled detector movement. The issues could result in the suspended mass of the detector potentially falling. A […]
RightEye receives FDA warning that its product is a medical device
An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device. The agency wrote in a letter, dated Dec. 20, 2022, that it inspected RightEye’s Bethesda, Maryland facility over 10 days in June and July 2022. In this inspection, it declared the RightEye Vision System a Class II Nystagmograph medical device. […]
FDA authorizes BD’s combo COVID-flu-RSV test
BD (NYSE:BDX) announced today that it received FDA emergency use authorization (EUA) for a COVID-19, flu and RSV combination diagnostic. The company designed the molecular test to detect SARS-CoV-2, influenza A and B and respiratory syncytial virus (RSV). It’s used on the BD Max molecular diagnostic system. The test uses a single nasal or nasopharyngeal […]
Tidepool Loop automated insulin delivery system wins FDA clearance
Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin delivery (AID) system. Palo Alto, California-based Tidepool is a non-profit diabetes data management group. It created the hybrid, closed-loop AID app for compatibility with multiple insulin pumps and continuous glucose monitors. The company announced collaborations in the past that include […]
Vero Biotech wins FDA approval for inhaled nitric oxide delivery with anesthesia in the OR
Vero Biotech announced that the FDA approved its second-generation Genosyl system for use with rebreathing anesthesia in the operating room setting. Atlanta-based Vero Biotech designed Genosyl for inhaled nitric oxide (iNO) delivery. This approval covers the second-generation Genosyl device. The third-generation device — which recently received FDA approval — has not yet been tested with […]
FDA clears single-use ureteroscope system from Boston Scientific
Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its LithoVue Elite single-use ureteroscope system. Marlborough, Massachusetts-based Boston Scientific plans a limited U.S. launch for the digital, flexible ureteroscope system in the coming weeks. The company said in a news release that it’s the first ureteroscope system that can monitor intrarenal pressure […]
Varian wins U.S., European clearance for radiotherapy systems
Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance and CE mark for its Halcyon and Ethos systems. Both radiotherapy systems feature Varian’s HyperSight imaging solution. HyperSight enables clinicians to capture high-quality images of patients during their daily radiation treatments. The images help in the daily localization of patient tumors and their uses […]
FDA clears biology-guided radiotherapy from RefleXion
RefleXion Medical announced today that the FDA cleared its Scintix biology-guided radiotherapy treatment for cancer. Hayward, California-based RefleXion designed the Scintix platform for use in treating both early- and late-stage cancers. The company said Scintix is the first and only radiotherapy that allows each cancer’s unique biology to autonomously determine how much radiation to deliver. […]
FDA approves fourth-gen rechargeable sacral neuromod tech from Axonics
Axonics (Nasdaq:AXNX) announced today that the FDA approved its fourth-generation R20 rechargeable sacral neuromodulation system. The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence. The approval indicates the Axonics R20 for a functional life in the body of at least 20 years. It also reduces the frequency with which a […]