Devices
FDA has issued a draft guidance, Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices, to revise a section of a 7/1/20 guidance on compliance dates for Class 1 and unclassified devices. The draft says certain Class 1 devices are
Devices
FDA has granted Varian a breakthrough device designation for its Embozene microspheres for genicular artery embolization (GAE) in treating symptomatic knee osteoarthritis. Embozene is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process, the company says. It is currently FDA cleared for
Devices
FDA has approved a Delphinus Medical Technologies PMA for its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjunct to digital mammography in screening asymptomatic women with dense breast tissue. “Clinical evidence has demonstrated that SoftVue enhances dense breast screening and identifies up to 20% more cancers
Devices
FDA has issued a safety alert about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes. “The FDA is aware of the potential for overdose if the user does not clear the moat area around the tip of the ENFit LDT syringe
Devices
FDA says it is aware that the U.S. is experiencing significant interruptions in the supply of sodium citrate blood specimen collection tubes, often called light blue top tubes, used for coagulation testing. An agency Frequently Asked Questions says the shortage is due to an increase in demand and recent
Devices
FDA has cleared a Life Spine 510(k) for the ProLift micro Expandable Spacer System. The device is designed to support micro invasive procedures ranging from endoscopic transforaminal and posterior lumbar interbody fusion procedures, the company says. It features an 8mm width, self-locking expansion at any height (8mm to
Devices
FDA has granted Quanterix a breakthrough device designation for its Simoa phospho-Tau 181 blood test as an aid in diagnosing Alzheimer’s Disease (AD). The designation was granted based on the test’s ability to detect low-abundance markers in a blood sample, which may provide earlier, more accessible
Devices
FDA has issued a warning to health care professionals to not use needle-free devices such as hyaluron pens for injecting hyaluronic acid or other lip and facial fillers (dermal fillers or fillers). The agency says serious adverse events have been reported in connection with their use, such as permanent
Devices
FDA says the Imperative Care 8/18 recall of specific lots of its ZOOM 71 reperfusion catheter due to the risk of breaks during use is Class 1. The company recalled 3,098 devices distributed in the U.S. between 9/23/20 and 8/9/21. Imperative Care says
Devices
FDA has issued a final order reclassifying surgical staplers for internal use from Class 1 (general controls) to Class 2 (special controls) and requiring them to undergo premarket review. An agency statement says that as a result of the order, surgical staplers for internal use “will be subject to more
Drugs
FDA has issued a complete response letter declining to approve in its current form a Polarean Imaging NDA for an investigational drug-device combination product using hyperpolarized xenon-129 gas to enhance MRI imaging in pulmonary medicine. The company says the letter was “unexpected” and contained issues that are “mostly
Devices
FDA says it has learned that Marci Beauty, Spring Valley, NV, is selling seven light therapy devices without marketing clearance or approval. A just-released 2/2 Warning Letter says the products are legally regulated as medical devices because they are intended for use in the diagnosis of disease or
Devices
FDA has classified as Class 1 a Medtronic recall of certain insulin pumps that was initiated to replace any pump that has a clear retainer ring with one that has the updated black retainer ring. Medtronic previously told customers about missing or broken clear retainer rings in the MiniMed 630G
Drugs
Former FDA human factors team leader Shannon Hoste has been named president of Agilis Consulting, which describes itself as a full-service medical human factors firm. Agilis says Hoste provided oversight to hundreds of human factors submissions to CDRH and CDER, making her a recognized expert in risk management and
Devices
FDA says Medtronic expanded its Class 1 recall of all MiniMed remote controllers used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to cybersecurity risks. Some 31,310 recalled units were distributed between 8/1999 and 7/2018. The company initiated the
Drugs
FDA says the Covid-19 pandemic has reinforced the need to adopt and accelerate the implementation of ways to increase critical supplies and supply chain resilience. An online Advanced Manufacturing update says advanced and smart manufacturing technologies have been identified as potential ways to meet the needs. The update cites
Devices
A new FDA final rule on the medical device de novo marketing pathway has modified earlier language contained in the proposed rule to now permit manufacturing inspections in limited scenarios. The rule establishes procedures and criteria for submitting a de novo request, which can occur after a device sponsor receives
Devices
FDA has released a document entitled “Best Practices for Communicating Cybersecurity Vulnerabilities to Patients.” The document is intended to provides helpful information and elements for industry stakeholders, federal partners, and other interested stakeholders to consider when developing a cybersecurity communication strategy. It was developed based on comments submitted to the
Devices
A new medical device user fee program independent assessment by Booz Allen finds that even during the pandemic and an increasing workload, CDRH continued to meet goals agreed upon its user fee commitment letter. The assessment, however, did find concerns with the Center’s new Electronic Submission Template And Resource
Devices
FDA has granted 510(k) clearance to Siemens Medical Solutions’ NAEOTOM Alpha computed tomography (CT) imaging device. An agency notice says the device is the “first major technological improvement for CT imaging in nearly a decade.” The device uses the emerging CT technology of photon-counting detectors that can measure
Drugs
FDA has published a draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices, to help clinical investigators comply with safety reporting requirements for IND or IDE studies. The document has recommendations to help investigators identify (1) safety information for drugs that is considered an unanticipated problem involving risk
Devices
FDA has cleared NeuroWave Systems’ NeuroSENSE NS-901 monitor, a new generation brain function monitor that assesses the adequacy of anesthesia and sedation in clinical settings. The company says NeuroSENSE is a unique bilateral brain function monitor for anesthesia specialists that simultaneously provides independent indices of anesthesia effect for each