Devices
Roche and Eli Lilly are collaborating to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), a blood test designed for making earlier diagnoses of Alzheimer’s disease. “If approved, the EAPP test would be an additional tool to identify low likelihood of amyloid pathology in symptomatic patients and determine whether
Drugs
CDER is making several requests if FDA chief scientist Namandjé Bumpus grants an Intarcia Therapeutics 2/21 petition seeking a public hearing before the FDA Endocrinologic and Metabolic Drugs Advisory Committee on the Center’s refusal to approve an Intarcia NDA for its ITCA 650 (exenatide in DUROS device). Intarcia
Devices
FDA has cleared a Brainomix 510(k) for its Brainomix 360 e-ASPECTS artificial intelligence (AI) tool for stroke diagnoses. The device is a collection of tools that use AI algorithms to support doctors by providing real time interpretation of brain scans to help guide treatment and transfer decisions for
Devices
FDA has cleared a Viz.ai 510(k) for its Viz AAA, an artificial intelligence (AI) algorithm intended to detect suspected abdominal aortic aneurysms (AAA). The device uses AI to automatically search for the presence of an abdominal aortic aneurysm from computed tomography angiography from any scanner in a hospital
Devices
CDRH is adding more functionality to its medical device electronic submission portal to prepare for an all-electronic submission process. Beginning 10/1, all 510(k) submissions including original submissions for Traditional, Special, and Abbreviated 510(k)s, and subsequent supplements and amendments will be required to be submitted in
Devices
Medical Device Manufacturers Association (MDMA) says it would be wasteful and duplicative to use medical device user fee funds to advance real-world data/evidence (RWD/RWE) activities with any new organizations. Responding to a request for comments, MDMA president Mark Leahy recommends that FDA and industry continue to develop
Devices
Device manufacturers should use FDA’s remote regulatory assessment (RRA) program as a template for how the agency will likely implement remote device facility inspection authority under last year’s Food and Drug Omnibus Reform Act (FDORA), according to former CDRH Office of Compliance director Steven Silverman. Writing in a
Devices
FDA has issued Olympus Medical Systems a Warning Letter after inspecting the firm’s Tokyo facility and documenting GMP deficiencies. According to the 3/15 letter, the 11/2022 inspection cited Olympus for failing to adequately establish and maintain procedures for implementing corrective and preventive actions. It also failed to
Devices
Datascope/Getinge has recalled its Cardiosave Hybrid IABPs and Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown. “An unexpected pump shutdown and any interruption to therapy that occurs can lead to unstable blood flow (hemodynamic instability), organ damage
Devices
FDA has granted 510(k) clearance for the BD Vaginal Panel on the BD COR system, a comprehensive diagnostic test that is said to directly detect the three most common infectious causes of vaginitis using BD’s high-throughput molecular diagnostic platform for large laboratories. A company statement says the
FDA Policy/General
FDA has published a draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers, with guidance for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic systems, records, and signatures in clinical investigations of medical products, food, tobacco
Drugs
As required by the Orange Book Transparency Act of 2020, the Government Accountability Office (GAO) has reviewed FDA Orange Book patent listings for drug/device combination products, including the listings’ implications for generic products. In a report, GAO says it interviewed 15 stakeholders on (1) how Orange Book patent listings
Devices
FDA has cleared a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the company’s existing artificial intelligence (AI)-powered Tyto Insights smart diagnostic for telehealth use. Wheeze Detection is designed to “aid in the clinical assessment of lung sound data for adults
Devices
Former Becton Dickinson (BD) medical director Hooman Noorchashm has petitioned FDA to “scrutinize” the company’s 2017 510(k) clearance for the GalaForm 3D due to label misrepresentations and “fraud on FDA.” Noorchashm’s petition alleges that BD “deliberately failed to reveal its true design to market and distribute the
Devices
FDA has cleared a PeekMed 510(k) for its Web-based artificial intelligence automated planning solution for use in orthopedic surgery. The product supports live automatic segmentation of CT scans and X-Rays, automatic landmarks detection, and automatic planning within 30 seconds, the company says. The device presents a total
Drugs
FDA has published a Federal Register notice outlining the status of the many guidance documents that were issued to address the Covid-19 public health emergency (PHE), which will officially end 5/11. Because many of the guidance documents issued during the PHE to address Covid-19 were tied to
Devices
A 3/8 letter from 18 Republican senators is urging HHS to abandon a Medicare pricing model that aims to balance incentives for developing novel treatments under FDA’s accelerated approval program (AAP) with potential harms of delayed confirmatory clinical trials. According to an HHS report (begins pg. 14), the
Devices
Baxter International says it has issued an “urgent medical device correction” for its Life2000 Ventilation System due to the “potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions” when the device is connected to a third-party oxygen concentrator.” The Life2000 system is manufactured
Biologics
FDA commissioner Robert Califf says truth is “losing the [misinformation] battle right now” and FDA and many other stakeholders can and must do more to try to protect people from medical misinformation. In an interview with the online newsletter Stat News, Califf said the agency may need to update its
Drugs
FDA’s just-released budget request for FY 2024 has the agency seeking a $372 million (10%) boost and a $150 million increase in user fees. The total funding being proposed for FDA, including $3.5 billion in total user fees, is $7.2 billion. “This funding will allow the
Devices
The Department of Justice says former Stimwave CEO Laura Perryman was named in a two-count indictment in connection with a scheme to create and sell a non-functioning dummy medical device for implantation in patients suffering from chronic pain, resulting in millions of dollars of losses to federal healthcare
Devices
CDRH director Jeff Shuren has taken the unusual step of addressing a company’s criticism directed at his Center’s alleged delay in granting an emergency use authorization (EUA) as a “misinformation” correction under FDA commissioner Robert Califf’s initiative to curb half-truths and misinformation that “pose enormous dangers