Devices
FDA has updated its mammography regulations to require mammography facilities to notify patients about the density of their breasts. An agency notice says the update also strengthens the agency’s oversight and enforcement of facilities and enables FDA to help doctors better categorize and assess mammograms. The notice says advising
Devices
FDA has granted Quidel a de novo marketing authorization (see approval letter) for its Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set. This is the first Covid-19 antigen test to be made available outside of an Emergency Use Authorization, according to CDRH director Jeff Shuren.
Devices
An FDA safety update indicates that it has received reports about squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. The update provides more information following a 9/2022 safety communication about reports of cancers, including SCC and various lymphomas that are not the same
Devices
FDA has cleared an Abbott 510(k) for its Alinity i TBI test, the first commercially available laboratory blood test for traumatic brain injury (TBI). The test runs on Abbott's Alinity i laboratory instrument. The test “offers a new reliable result in 18 minutes to help clinicians quickly
Devices
FDA says that more testing and analysis are needed to determine if several toxic compounds are present in additional hemodialysis and peritoneal dialysis systems. Updating its 5/6/22 letter to healthcare providers on the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids
Devices
FDA has granted Neuromod Devices a de novo request to market Lenire, the first bimodal neuromodulation device for treating tinnitus. The device comprises a controller, a tongue stimulator, and Bluetooth headphones. The handheld controller controls the timing, intensity and synchronization of the sound and tongue stimuli, according to the company.
Devices
FDA has cleared an Abbott 510(k) for its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring system sensors for integration with automated insulin delivery (AID) systems. Abbott says it modified the sensors to allow their integration with AID systems. AID systems assist patients with managing daily
Devices
FDA has cleared a FloSpine 510(k) for its a 3D-printed titanium Ti-Largo cervical interbody cage system to support the spine after a cervical collapse or a damaged disc has been removed and to restore height. The implants use titanium additive manufacturing (3D printing) and a patent-pending
Devices
FDA has cleared a Convatec 510(k) for its InnovaMatrix PD particulate placental extracellular matrix medical device for wound management. The product is made with Convatec’s proprietary TriCleanse Placental Extracellular Matrix Process, “which thoroughly decellularizes the [extracellular matrix] ECM, disinfects the tissue and deactivates viruses while maintaining structural proteins
Devices
FDA has cleared a Noah Medical 510(k) for the Galaxy System, a robotic-navigated bronchoscopy device and accessories that are intended to provide bronchoscopic visualization and access to patient airways for diagnostic and therapeutic procedures. The company says the majority of cancerous lesions are located in the outer third
Drugs
The Sedgwick product safety and recall 2022 report, State of the Nation 2023, says that pharmaceutical recall events increased by 32.5% from 274 in 2021 to 363 in 2022. Comparably, medical device recall events went up 11.4% from 837 in 2021 to 932, the report says. Current good
Devices
FDA has rejected a request from Elon Musk’s Neuralink for permission to conduct human trials of a brain implant that Musk has said will ultimately make the paralyzed walk and the blind see. Reuters reports that the agency listed dozens of deficiencies that must be resolved before any approval
Devices
With the 10/1 deadline for the required use of FDA’s electronic Submission Template and Resource (eSTAR) templates for 510(k) submissions approaching, Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz says there is a bit of a learning curve in determining a good process for
Devices
An FDA letter to healthcare professionals is warning about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The blood oxygenation and carbon dioxide removal system is used to pump blood through the extracorporeal bypass circuit for either circulatory support, pulmonary support, or both, for
Drugs
CBER issued four new Standard Operating Policy and Procedure (SOPP) documents on 2/27: SOPP 8421: Complying with Requirements Under the Pediatric Research Equity Act (PREA) is a first-line resource for product offices and review divisions to ensure that sponsors/applicants and CBER staff are following the required procedures
Devices
FDA has issued a letter to healthcare providers warning about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta heart valves, including the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets mounted to the valve frame. “Information from published literature suggests
Devices
FDA has issued Lucira an emergency use authorization for the first over-the-counter (OTC) at-home diagnostic test for detecting influenza A and B, and Covid-19. The single-use test uses nasal swab samples and provides results in about 30 minutes. Those being tested should report positive results
Devices
An FDA 12/9/22 draft guidance, Content of Human Factors Information in Medical Device Marketing Submissions, “seems like mission creep” for FDA to go beyond the stated primary purpose to impose a dramatic expansion of the requirement. That’s the view of attorney Jeffrey Shapiro (Hyman, Phelps & McNamara)
Devices
FDA says it has added a new case study to the Examples of Medical Device Misconnections Web page. An agency notice says the new case study involves an air inflation line from a noninvasive vascular diagnostic system erroneously connected to an intravenous catheter with the same connector as a blood
Devices
FDA has published a “sources sought” information request to survey potential contractors on their expertise and capabilities to develop and implement a medical device active surveillance system involving electronic health record (EHR) data to better understand device safety within clinical practice settings. The agency says the primary need for an
Devices
FDA says it is evaluating published literature that reports elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals from neonatal incubators. An agency letter to healthcare providers says the potential sources of the airborne chemicals include materials used to make the incubators as well as natural and human-made sources
Devices
FDA has published three guidances relating to x-ray systems. The first, Performance Standards for Diagnostic X-Ray Systems and Their Major Components; Small Entity Compliance Guide, is intended to assist small entities to comply with a 2005 final rule amending the performance standard for diagnostic x-ray systems and