The FDA granted integrated CGM (iCGM) designation to the Eversense continuous glucose monitoring system from Senseonics (NYSE:SENS). With this designation, Eversense becomes the first fully implantable device in the category. Senseonics can now market the long-term CGM through the FDA’s de novo pathway. This establishes the special controls serving as a predicate device for future […]
Food & Drug Administration (FDA)
FDA issues warning letter to Cardinal Health for adulterated and misbranded medical devices
The FDA recently issued a warning letter to Cardinal Health following an inspection at one of its facilities. The inspection revealed unapproved device violations pertaining to the Monoject Leur-lock tip syringes and the Monoject Enteral Feeding Syringes, as well as quality system regulation violations. Dublin, Ohio-based Cardinal Health was found to be marketing convenience kits […]
FDA clears new patient monitor from GE HealthCare
GE HealthCare announced today that it received FDA 510(k) clearance for its Portrait VSM vital signs monitor. Portrait VSM provides clinicians with an accurate view of patient vital signs to support timely clinical decisions. It utilizes the SuperSTAT non-invasive blood pressure algorithm to provide precise and accurate measurement readings. Through wireless connectivity and seamless EMR […]
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
Abbott wins FDA approval for dissolving drug-eluting scaffold
Abbott announced today that the FDA approved its Esprit everolimus-eluting resorbable scaffold system. The Esprit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. Abbott says that before this approval, there were no stents or drug-coated […]
Philips gets judge’s OK to settle Respironics recall economic losses
Philips will pay at least $613 million to settle economic lawsuits related to its recall of millions of CPAPs and other respiratory devices. U.S. District Court Judge Joy Flowers Conti, who has been overseeing the multidistrict litigation out of her court in Western Pennsylvania, approved the final settlement yesterday. “The amount of value created and […]
Roivios wins FDA breakthrough nod for renal assist device
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 […]
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 […]
Philips receives FDA warning letter over imaging systems manufactured in China
The FDA published a warning letter that it sent to Philips that outlines issues around imaging technology manufacturing practices. During an inspection of a manufacturing facility in Suzhou, China, the FDA determined that the devices are “adultered.” The inspection took place from Oct. 23, 2023, through Oct. 26, 2023. Philips received the letter outlining violations […]
Fresenius Medical Care recalls more than 2 million catheter components
The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind. Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March […]
FDA says InfuTronix infusion pump recall includes 1 death
The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death. Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues […]