Devices
FDA has granted Singlera Genomics a breakthrough device designation for its PDACatch assay, a DNA methylation-based liquid biopsy assay for detecting pancreatic adenocarcinoma in individuals at high risk for the disease. The device is based on Singlera's MethylTitan platform, which “utilizes a proprietary library construction approach and
Devices
FDA has cleared a Samsung Electronics 510(k) for its Irregular Heart Rhythm Notification (IHRN) feature on its Health Monitor app for Samsung Galaxy watches. “Together with the app’s existing on-demand Electrocardiogram (ECG) function, the IHRN feature proactively monitors heart rhythms suggestive of atrial fibrillation (AFib), right from
Devices
CDRH has launched a new Web page entitled “Antimicrobial Resistance and Medical Devices” that is intended to explain how antimicrobial susceptibility tests are used to help health care providers identify the correct therapy to treat specific bacterial or fungal infections. The devices are sold for use in clinical laboratories and
Devices
FDA has updated its Catalog of Regulatory Science Tools to Help Assess New Medical Devices by adding three new tools and updating five tools. An online post says the new tools are: * Additively Manufactured Mock Spine Cage Designs for Mechanical Performance Test Assessments: STL Set 1; * Lumbar Integrated Fixation Devices
Devices
FDA has issued a warning on SD Biosensor’s Pilot Covid-19 At-Home Tests, distributed by Roche Diagnostics, due to bacterial contamination concerns with its liquid solution. “Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test,
Devices
FDA has cleared a Nano-X Imaging 510(k) for its Nanox ARC, a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography in adult patients. The clearance also covers the company’s Nanox Cloud, a cloud-based infrastructure. The company
Devices
FDA has cleared a Casana 510(k) for the Heart Seat, a smart toilet seat for measuring heart rate and oxygen saturation (SpO2). The device is part of what the company calls its push for “effortless, integrated, and consistent in-home health monitoring.” Casana says it has also partnered with
Biologics
FDA has published a draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, with recommendations for sponsors, investigators, and other stakeholders on the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. The document defines a decentralized clinical trial as one in which some
Devices
FDA has granted DirectSync Surgical a breakthrough device designation for its patient-powered smart spinal fusion device. The designation is based on FDA’s review of preliminary data that determined the DirectSync Surgical interbody device may provide a more effective spinal fusion than the current standard of care, the company
Devices
FDA has approved a Medtronic PMA for its Micra AV2 and Micra VR2 next-generation miniaturized, leadless pacemakers. The devices are designed to provide longer battery life and easier programming than prior Micra pacemakers, the company says. The Micra AV2 device also includes advanced algorithms that automatically program atrioventricular (AV)
Devices
FDA has issued Princeton BioMeditech an emergency use authorization for its Covid-19 Antigen Rapid Test for Home Use, an over-the-counter Covid-19 antigen diagnostic test that produces results in 15 minutes. “The test can be used for serial testing for people who have symptoms within the first
Devices
The Center for U.S. Policy (CUSP) has filed a Citizen Petition asking FDA to deem a widely used clinical decision support software, Bamboo Health’s NarxCare, a misbranded medical device and to mandate a recall to prevent serious, adverse health consequences and death. The software is a substance use
Drugs
Bipartisan legislation to make the U.S. pharmaceutical supply chain less dependent on China and other foreign countries has been reintroduced by Reps. Earl Carter (R-GA), Darren Soto (D-FL), Carol Miller (R-WV), and Matt Cartwright (D-PA). A statement (includes a link to the bill text) issued
Devices
FDA has granted Ultromics a breakthrough device designation for its artificial intelligence (AI)-supported platform for detecting cardiac amyloidosis. The EchoGo Amyloidosis uses AI to analyze echocardiograms and detect cardiac amyloidosis, a condition caused by abnormal protein deposits in the heart tissue. The process is completed using a single, commonly
Devices
FDA has issued an alert about a cybersecurity vulnerability affecting the Universal Copy Service software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments. The devices are specified either for clinical diagnostic use in sequencing a
Devices
FDA has lifted a 2021 Warning Letter to Medtronic that followed an inspection of the company’s diabetes headquarters in Northridge, CA. “The resolution of the Warning Letter follows ongoing remediation actions from the company and proactive actions to continue to strengthen its quality systems,” the company says. “All regulatory
Devices
An 8/8-8/11/22 FDA inspection at Medivance Instruments in London, UK, determined that the firm manufactures the Velopex Aquacut Fluid Abrasion Unit and accessories as part of its Velopex AquaCare dental abrasion line of products. A just-released 2/13 Warning Letter says the firm holds a
Devices
FDA has cleared a Maxtec 510(k) for the MaxO2 ME+p, an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. The company says the device is also designed for use in
Devices
Avanos Medical has recalled its Avanos Ballard Access Closed Suction System with Y-Manifold or Elbow Manifold (labeled 72-hour-use) after receiving complaints about cracked manifolds during use. “A cracked manifold can cause leaks in the respiratory circuit, which may lead to the patient receiving inadequate ventilation,” a recall
Devices
FDA is providing further clarification about a safety alert issued earlier this month that recommended 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. Laboratorytests show these masks “do
Devices
Fresenius Kabi has recalled its Ivenix Infusion System due to a leak in the device that allows fluid to enter the administration set loading area near the air detector. If such leaks occur, they could damage the electrical system, leading to loss of power and failure of the system’s
Devices
A 6/14-6/23/22 FDA inspection at the North American Diagnostics medical device operations in Holly Hill, FL, found that the firm manufactures and distributes several unapproved Covid-19 tests. A just-released 12/27/22 Warning Letter says the company acknowledged that it had “improperly distributed into