Devices
FDA says device makers can now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal. The portal is now set up for any device company to register for a portal account to send electronic submissions online. Under the new
Devices
FDA has published three guidances describing agency and industry actions on three types of medical device submissions – de novo, 510(k) and PMA – and the effect the actions have on the FDA review clock and goals. The documents cover performance goals negotiated as part of the MDUFA 5 reauthorization. The
Devices
FDA has cleared a GE Healthcare 510(k) for its AIR Recon DL for 3D and Propeller imaging sequences for use during magnetic resonance imaging (MRI) clinical procedures, claimed to enable better image quality and shorter scan times. The device's image reconstruction technology for MRI is now expanded
Devices
LivaNova (TandemLife) has recalled its LifeSPARC Controller, part of the LifeSPARC pump system, due to a software malfunction. The controller’s monitoring feature may erroneously detect “frozen or unresponsive software and trigger the device to enter critical failure mode — clearing the controller screen and issuing an alarm that cannot be
Devices
A new final guidance on Clinical Decision Support (CDS) Software appears to be “more expansive in scope” than an earlier draft version, and many software products previously not regulated by FDA may now be subject to agency oversight, according to a legal analysis by attorneys at the law firm DLA
Devices
FDA has published a guidance, Display Devices for Diagnostic Radiology, to assist industry in preparing 510(k) submissions for display devices intended for use in diagnostic radiology. The document says while it is intended to apply to current technologies, FDA may request new or alternative methods to fully evaluate the
Devices
FDA has published a guidance, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, with the agency’s current thinking on the listed devices to provide clarity and predictability for their manufacturers. The document notes that FDA down-classified medical device data systems (MDDS) from Class
Devices
FDA has cleared a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system. The device uses a noncontact, nonthermal hemostatic powder, which is sprayed through a catheter that has a proprietary powder coating to minimize clogging and provide improved visibility and control for treating upper gastrointestinal nonvariceal bleeding, according to
Devices
FDA has published a guidance, Policy for Device Software Functions and Mobile Medical Applications, to inform manufacturers, distributors, and other entities about how the agency intends to apply its regulatory authorities to select software functions intended for use on mobile platforms or general-purpose computing platforms. “Given the rapid expansion
Devices
FDA says it will collaborate with the Veterans Health Administration on efforts to help accelerate American medical device innovation to further improve and benefit public health. An agency notice says the VA Ventures Innovation Institute in Seattle, WA, will host up to 12 FDA staff to foster robust collaboration between
Devices
FDA has published a guidance, Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Notification [510(k)] Submissions, with recommendations for 510(k) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The document says CADe devices are computerized systems
Devices
FDA has issued a revised final guidance entitled “Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions.” The document provides recommendations on clinical performance assessments of computer-assisted detection (CADe) devices applied to radiology images and
Devices
Attorneys Steven Gonzalez and Jeffrey Wasserstein (Hyman, Phelps & McNamara) say a recent New Jersey Supreme Court decision demonstrates that the issuance and wording of FDA safety notices can potentially affect the civil liability exposure of the customers of medical device manufacturers. Writing in their firm’s FDA Law Blog,
Devices
FDA is changing its Covid-19 test policy to reduce the number of tests reviewed for an emergency use authorization (EUA) and increase the number of tests authorized through the traditional de novo classification or 510(k) clearance pathways. In an online statement, FDA says more than 430 distinct Covid-
Devices
FDA has published a guidance, Clinical Decision Support Software, to clarify the scope of the agency’s oversight of clinical decision support (CDS) software intended for healthcare professionals. “Not all clinical decision support software used in healthcare settings are devices and therefore subject to FDA oversight as a device,” the
Devices
FDA says a recent pilot program on software as a medical device has shown that a new regulatory paradigm is needed to regulate such devices, but this would require a legislative change. Based on the observations from the pilot, FDA determined that the approach described in the pilot’s “working
Devices
FDA has granted QT Imaging a 510(k) clearance for its QTscan to calculate the fibroglandular volume of the breast and the ratio of that to total breast volume. “This ratio can contribute to an assessment of risk for breast cancer and changes in this ratio can be used to
Devices
Philips Respironics has recalled (Class 1) certain BiPAP (bi-level positive airway pressure) ventilators that may contain a plastic contaminated with a non-compatible material. “If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs),” an FDA recall notice says.
Devices
FDA has approved the treatment of non-left main bifurcation lesions with the Medtronic provisional bifurcation stenting technique using the Onyx Frontier and Resolute Onyx drug-eluting stents. Medtronic says it is the only company to be approved for this indication in the U.S. The company says bifurcation lesions
Devices
FDA has cleared an Iterative Scopes 510(k) for SKOUT, a real-time computer-aided polyp detection device for adults undergoing colorectal cancer screening or surveillance. The device uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists, the company says. The clearance
Devices
The HHS Office of Inspector General (OIG) says there are lessons to be learned from the way FDA approached Emergency Use Authorization (EUA) policies for Covid-19 testing. The OIG says that to develop its report, it relied on FDA documents, data, and interviews to determine how the agency conducted
Devices
FDA has cleared a Medtronic 510(k) for its LINQ II Insertable Cardiac Monitor (ICM) system for expanded use in pediatric patients over the age of two years who have heart rhythm abnormalities and require long-term, continuous monitoring. The tiny implantable device (one-third the size of a AAA