Devices
FDA has approved a BlackSwan Vascular PMA for its Lava Liquid Embolic System for treating peripheral arterial hemorrhage. The company describes the device as a “liquid embolic product” specifically indicated for embolization of peripheral arterial hemorrhages. Liquid embolic agents are injected as a liquid and solidify after entering the vasculature,
Devices
A 5/16-5/19/22 FDA inspection at an Abbott Point of Care Canada facility in Ottawa, Canada, found multiple violations in the firm’s manufacturing of the i-STAT cTnI test intended for the quantitative measurement of cardiac troponin I in whole blood or plasma. A just-released
Devices
FDA has cleared an Abbott 510(k) for a reader for its FreeStyle Libre 3 integrated continuous glucose monitoring system. The reader is a small handheld device that displays real-time glucose readings obtained from a small sensor worn on the back of a person’s upper arm, allowing them
Devices
FDA has cleared a Moximed 510(k) for its MISHA Knee System, an implantable shock absorber for use in patients with medial knee osteoarthritis (OA). The device is indicated for those who failed to find relief from non-surgical or surgical treatment, and are ineligible for, or unwilling to undergo,
Devices
FDA has published a final guidance, Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters—Premarket Notification (510(k)) Submissions, with recommendations, including bench testing and coating characterizations for 510(k) submissions for PTA balloon and specialty catheters. The document provides anatomy-specific testing recommendations and expands on the agency’s
Devices
FDA has accepted for review a AlgoDx de novo marketing request for Navoy Sepsis, a clinical decision support software intended to assist healthcare providers at intensive care units (ICU) with predicting sepsis in adult patients. The prediction algorithm software is based on machine learning that “accurately predicts the risk of
Devices
FDA issued a 4/13 updated medical device safety communication to provide transparency for consumers who are awaiting a Philips replacement BiPAP or CPAP machine to clarify that the number of replacement and remediated devices that have been shipped to consumers in the U.S. is considerably less than the
Devices
Researchers from the University of Missouri-Kansas City and other facilities say post-approval modifications to Class 3 medical devices approved through the premarket approval (PMA) supplement process are associated with an increased risk of device recall. The study, published by JAMA Network Open, says an “increase of one supplement
Devices
An FDA safety alert is recommending against the use of certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by the company. Laboratory test results show certain models of O&M Halyard surgical N95 respirators,
Devices
Attorneys Dominick DiSabatino and Audrey Crowell (Sheppard Mullin) say a recent FDA guidance and FAQ document explain new medical device cybersecurity safeguard requirements from the Consolidated Appropriations Act of 2023. The attorneys cover which submissions are subject to the new cybersecurity requirements, what the new requirements are, and how the
Devices
A hard-hitting SC Media online post says even the most equipped health systems are unprepared to meet FDA’s new medical device cybersecurity safeguards. The post looks at FDA guidance to implement new requirements from the Consolidated Appropriations Act of 2023 and the six-month grace period given until
Devices
FDA has announced a voluntary Radiation Sterilization Master File Pilot Program to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. A notice says the pilot will be open to nine companies that sterilize single-use, PMA-
Devices
CDRH director Jeff Shuren acknowledged that new regulatory reforms from Congress will be needed for FDA and the medical device industry to experience transformative outcomes from the quickly developing artificial intelligence (AI) and software-driven medical device space. Speaking at an American Enterprise Institute panel on the future of AI,
Devices
FDA has granted Reach Neuro a breakthrough designation for its Avantis platform, which the company says uses small electrical impulses delivered to the spinal cord to help restore shoulder, arm, and hand movement to patients impaired due to chronic stroke. The designation is based on data showing two study subjects
Devices
Philips is recalling (Class1) certain reworked DreamStation breathing devices because some were assigned incorrect or duplicate serial numbers during initial programming. “This duplication can cause therapy to be delivered using the wrong prescription or factory default settings,” a recall notice says, adding that it may fail to deliver any therapy
Devices
Florida has won a $600,000 payment to the state’s Medicaid program under a multistate action against cochlear implants maker Advanced Bionics. The state’s action grew out of a Department of Justice (DoJ) $12 million whistleblower settlement earlier this year (see story) that resolved allegations that the firm
Devices
FDA is soliciting responses to five questions as part of its commitment to meeting the MDUFA 5 performance goals by taking actions to engage patients and incorporate their perspectives in the regulatory process. An agency notice says FDA is considering revising a final guidance, Patient Preference Information—Voluntary Submission, Review
Devices
FDA has cleared a restor3d 510(k) for the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The 3-D manufactured patient-specific resection device is made from titanium alloy, and its streamlined features are designed to sit on the bone and offer greater
Devices
A Roll Call analysis of efforts to date to develop a pandemic preparedness reauthorization bill indicates that FDA oversight of laboratory-developed diagnostic tests is likely to be part of the debate. The article says the effort to strengthen FDA oversight was dropped at the end of 2022 amid House
Devices
FDA has approved a Synapse Biomedical PMA for the NeuRx Diaphragm Pacing System for use in patients with spinal cord injuries who rely on mechanical ventilation. The company says the device is designed as an option for spinal cord injury (SCI) patients who prefer a “more natural method of breathing.
Devices
Three former top officials at Magellan Diagnostics (Billerica, MA) have been charged over their role in allegedly concealing a device malfunction that produced inaccurately low lead test results for tens of thousands of children and other patients. Former CEO Amy Winslow, former chief operating officer Hossein Maleknia, and former quality
Devices
FDA says Abbott has issued a safety notice for the Readers and batteries used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash glucose monitoring systems. The Readers are small handheld devices that collect real-time glucose readings directly from a sensor worn on