Biologics
FDA commissioner Stephen Hahn and senior advisor Colin Rom say the agency has signed a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products, and medical devices through the adoption
Devices
FDA has cleared a DePuy Synthes 510(k) for the Velys Robotic-Assisted Solution and its use with the Attune Total Knee System. The robotic device is designed to adapt to the “surgeon’s workflow, and is designed to give them the control they are used to and helps them
Devices
FDA has given PMA approval for Seno Medical Instruments’ diagnostic breast cancer imaging technology that the company says helps doctors better differentiate between benign and malignant breast lesions. Seno says its Imagio breast imaging system uses non-invasive opto-acoustic ultrasound technology to provide real-time information on suspicious breast
Devices
FDA has announced the unsealing of an indictment charging two former Michigan-based Beaumont Hospital employees and a medical supply distributor with wire fraud based on their scheme to steal medical devices from the hospital and then sell them on the Internet. Charged were: Paul Purdy, 49, of Beavercreek, OH;
Devices
FDA has issued an immediately-in-effect guidance, Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, to provide a policy to help expand the availability of coagulation systems for measuring whole blood viscoelastic properties that are used to assess
Devices
Writing in a New England Journal of Medicine Perspective article, three CDRH staffers review new studies on the safety of paclitaxel-coated devices (PCDs) used to treat atherosclerotic peripheral arterial disease (PAD) and call for ongoing data collection. The article discusses questions that have been raised about the devices’ safety
Devices
Two SheppardMullin attorneys say the quick takeaway from the 1/12 publication of an FDA action plan for artificial intelligence and machine learning (AI/ML) software is that the agency will publish a guidance on change control plans, a key concept from its 4/2020 discussion paper on AI/ML
Devices
Two Hogan Lovells attorneys say FDA will begin accepting Safer Technologies Program (STeP) for Medical Devices requests 3/8. Writing in an online analysis, the attorneys outline the provisions of a 1/6 final guidance describing the voluntary program for medical device and device-led combination products that offer a
Devices
The CDRH Digital Health Center of Excellence has issued its “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan.” An agency statement (contains a link to the action plan) says the plan is a direct response to stakeholder feedback to a 4/2019 discussion paper
Devices
The Pew Charitable Trusts says Congress should act quickly to approve legislation establishing a “unified, risk-based FDA regulatory system for diagnostics, including laboratory-developed tests (LDTs).” A 1/11 Issue Brief says the need for congressional action was heightened by an 8/2020 HHS announcement that FDA does not
Devices
FDA has given PMA approval to the MicroVention WEB 17 system, a new addition to the WEB aneurysm embolization system for treating intracranial wide-neck bifurcation aneurysms. The company says the WEB 17 system features a lower profile delivery system compatible with the VIA 17 microcatheter and includes additional device
Devices
Boston Scientific has recalled all unused inventory of its Lotus Edge Aortic Valve System due to “complexities” associated with the product delivery system, according to a recall notice. The recall is related specifically to the delivery system, and the valve “continues to achieve positive and clinically effective performance post-implant,
Devices
FDA is alerting clinical laboratory staff and health care providers about the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized Covid-19 molecular tests, and that false negative results can occur with any molecular test
Devices
FDA has granted Functional Neuromodulation a breakthrough device designation for the Vercise Deep Brain Stimulation (DBS) System, developed and manufactured by Boston Scientific, for treating patients 65 years and older with mild probable Alzheimer’s disease. Functional Neuromodulation says a pivotal trial is underway to evaluate the safety and efficacy
Devices
Tidepool, an open source diabetes nonprofit, has submitted a 510(k) for an automated insulin dosing app for use on the iPhone for managing Type 1 diabetes. The agency has told the company that the submission had completed FDA’s administrative acceptance review and was proceeding to substantive review as
Devices
FDA will participate in the new Pathology Innovation Collaborative Community being convened by the Medical Device Innovation Consortium (MDIC) as a regulatory science initiative aiming to facilitate innovations in pathology that may advance safety and effectiveness evaluation. The group also is to harmonize approaches to speed delivery to patients using
Devices
FDA has cleared the CardioWise Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ), an image analysis software application for cardiac computer tomography (CT) studies to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The company says SQuEEZ is based on the ability in sequential high-resolution cardiac
Devices
FDA has published a guidance, Safer Technologies Program for Medical Devices, to introduce a new voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with
Devices
FDA has issued a safety alert about false result risks (mostly false negatives) with KorvaLabs’ Curative SARS-Cov-2 (Covid-19) test. To reduce the risk of false negative results, it is important to perform the test in accordance with its emergency use authorization and as described in the authorized
Devices
FDA has published a guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, with an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA on various types of potential or planned medical device submissions. The document says the
Devices
FDA has authorized the marketing of Interscope’s EndoRotor system to resect and remove necrotic tissue for patients with walled-off pancreatic necrosis. An agency statement says the system includes a power console, foot control, specimen trap, and single-use catheter, and is used in a direct endoscopic necrosectomy. The
Devices
FDA has published a guidance, Product Labeling for Laparoscopic Power Morcellators, with recommendations on the content and format for certain labeling information for laparoscopic power morcellators (LPM). The document says the recommendations reflect the state of the science and available technology regarding the use of LPMs and are being made