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 […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
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 […]
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 […]
Boston Scientific warns on some Vercise Genus implantable pulse generators
Boston Scientific recently issued an urgent field safety notice for certain Vercise Genus deep brain stimulation (DBS) implantable pulse generators. In the urgent field safety notice released in the United Kingdom, the company warned about the potential for Vercise Genus DBS IPG stimulation therapy to be transiently suspended during charging due to a device reset. […]
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 […]
BD warns on some neXus V700 infusion pumps outside the U.S.
BD issued an urgent field safety notice in the UK to warn of potential issues with its Alaris neXus V700 infusion pump system. According to the notice, BD identified that the anti-free flow clamp may not activate when the system door opens. This allows for the potential uncontrolled flow of medication. The issue does not […]
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 […]
FDA labels Outset Medical recall of Tablo hemodialysis system as Class I
The FDA today labeled Outset Medical’s recall of some Tablo hemodialysis devices as Class I, the most serious kind. The news comes only weeks after analysts expressed optimism that the company was moving ahead of previous regulatory challenges with the FDA. Outset Medical recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching […]
FDA wants to advance health equity through home-based care
The FDA has announced an initiative to reimagine the home environment as an integral part of the healthcare system and promote health equity for all Americans. The new initiative, called “Home as a Health Care Hub,” seeks to address the longstanding disparities in healthcare access and outcomes using home-based care. FDA’s Center for Devices and […]