Masimo announced today that the FDA granted 510(k) clearance for its W1 medical watch for connectivity purposes. Clearance allows for the watch to integrate with the Masimo SafetyNet comprehensive telemonitoring system. Last fall, the FDA cleared the W1 watch, which provides continuous oxygen saturation (SpO2) and pulse rate (PR) for over-the-counter and prescription use at […]
Food & Drug Administration (FDA)
Recall of Medtronic nerve monitoring tech is Class I
The FDA identified a recall of Medtronic nerve monitoring systems as Class I, the most serious kind of recall. This recall involves correcting devices, not removing them from the market. The device may cause serious injury or death if people continue using it without correction, the FDA says. Medtronic’s correction involves its NIM vital nerve […]
FDA expands labeling for Linx reflux management system from J&J’s Ethicon
J&J MedTech’s Ethicon announced today that it received expanded FDA labeling for its Linx reflux management system. The new FDA labeling expands Linx’s availability to include patients with Barrett’s esophagus (BE) experiencing gastroesophageal reflux disease (GERD) symptoms. The FDA based its decision on a retrospective review of a 2021 study that found Linx safe and […]
Karl Storz’s AventaMed wins FDA nod for ear tube placement device
AventaMed, a Karl Storz company, announced that it received FDA 510(k) clearance for its Solo+ ear tube placement system. Solo+ combines multiple steps into an all-in-one device for a simplified approach to enable office-based pediatric tympanostomies. To date, ear tube placement typically takes place in an operating room and requires general anesthesia. The company designed […]
Medtronic wins FDA nod for next-gen Simplera CGM
Medtronic got another boost for its CGM portfolio, adding to the collaboration with Abbott announced today. Our sibling site, Drug Delivery Business News, reported today that the medtech giant received FDA approval for its Simplera continuous glucose monitor (CGM). Simplera, the company’s first disposable, all-in-one CGM, comes in at half the size of previous Medtronic CGMs. Its […]
Medtronic GI Genius rolls out with next-gen hardware
Cosmo Intelligent Medical Devices announced that it received FDA clearance for the next-generation GI Genius hardware distributed by Medtronic . The latest milestone marks the sixth generation of the GI Genius hardware, which Medtronic exclusively distributes globally. The medtech giant unveiled next-generation ColonPRO software for the platform earlier this year. Related: How Cosmo cranked up […]
Diality wins FDA clearance for hemodialysis system
Diality announced today that it received FDA 510(k) clearance for its Moda-flx smart, flexible hemodialysis system. Irvine, California–based Diality designed the system to provide kidney care professionals with a wide range of variable flow rate ranges, integrated reverse osmosis water filtration and an intuitive, easy-to-use graphical user interface. It provides clinicians with the flexibility to […]
Pentax wins FDA nod for duodenoscope with new sterilization tech
Pentax Medical announced today that the FDA cleared its DEC duodenoscope compatibility with the Sterrad 100NX sterilizer. Advanced Sterilization Products (ASP) develops Sterrad as its flagship product. Together, the companies aim to address the ongoing challenges of duodenoscope reprocessing. They hope to reduce the risk of cross-contamination with the scopes, enabling easier access to sterilized […]
iRhythm stock is down on news of more FDA inspection issues
Wearable heart monitor company iRhythm saw its stock fall today on news of additional FDA inspection issues and a surprise CFO exit. IRTC shares were down more than 10% to $75.68 apeice by midday trading today. MassDevice‘s Medtech 100 Index was down half a percent. The disclosures, which came after market close yesterday, accompanied a […]
Inspire Medical wins FDA nod for next-gen sleep apnea neurostim
Inspire Medical Systems announced today that it received FDA approval for its Inspire V therapy system. Inspire V includes a next-generation neurostimulator and associated Bluetooth patient remote and physician programmer. It marks the latest innovation for the Minneapolis-based obstructive sleep apnea (OSA) treatment developer. The pacemaker-like device delivers mild electrical stimulation to the hypoglossal nerve, […]
MiRus wins FDA breakthrough nod for spine implant
MiRus announced that it received FDA breakthrough device designation for its Europa posterior cervical system for the spine. The system, built on MiRus’ proprietary rhenium alloys, received the breakthrough designation for treating the cervical and upper thoracic spine. MiRus developed it around a 2.9 mm MoRe rod, which it says is much smaller than current […]
