Devices
The 9th Circuit Court of Appeals has rejected device preemption arguments from C.R. Bard in a product liability lawsuit involving the company’s G2 Intravascular Filter. The panel of judges affirmed a lower court’s ruling in favor of the plaintiff and rejected Bard’s motion for summary judgment
Devices
FDA has issued two final guidances providing performance criteria for conventional foley catheters and cutaneous electrodes for recording purposes in support of the safety and performance-based pathway. The agency says that under the pathway, medical device manufacturers planning to submit a 510(k) for the devices have the option
Devices
FDA has published two frequently asked questions documents relating to medical device issues during the Covid-19 pandemic. Registration and Listing of Medical Devices During the Covid-19 Pandemic provides information for medical device establishments, including owners and operators of places of business that are involved in the production and
Devices
FDA has cleared a RapidAI 510(k) for the Rapid LVO for detecting suspected large vessel occlusions (LVOs). The device, which provides results in about three minutes, uses a vessel tracker in conjunction with an assessment of brain regions with reduced blood vessel density to identify suspected LVOs with a
Devices
FDA has cleared Deep Blue Medical Advances’ 510(k) for its T-Line hernia mesh with integrated suture-like extensions. The company says the product provides superior anchoring strength and eliminates a key point of failure for conventional mesh fixation — the mesh/suture/tissue interface. Deep Blue says it expects
Drugs
FDA has approved a Lantheus and Progenics Pharmaceuticals supplemental NDA for Vialmix RFID for Definity. The product is described by the companies as a next generation activation device designed specifically for Definity Vial (perflutren lipid microsphere) for injectable suspension, an intravenous ultrasound enhancing agent. “Definity is supplied as a liquid-
Devices
FDA has cleared a MagVenture 510(k) for its TMS Therapy as an adjunct treatment for obsessive-compulsive disorder (OCD). Previously, the device was cleared for treating major depressive disorder. The device uses repetitive transcranial magnetic stimulation to delivers magnetic pulses to stimulate nerve cells in the part of the
Devices
CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel says FDA has authorized over 200 SARS-CoV-2 tests in the emergency use authorization pathway. Speaking on an 8/5 virtual town hall on development and validation of coronavirus tests, Stenzel said there are “hundreds of EUA
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-X Ti Lateral Lumbar Spacer System. The device is intended for use by surgeons to provide anterior column support through a lateral approach. It includes a comprehensive set of instruments and implants to streamline the surgical procedure, the company
Devices
Becton, Dickinson (BD) has recalled its ChloraPrep 3 mL applicator due to possible fungal contamination, which only affects climate zone IV regions in specific U.S. territories (Puerto Rico, Guam, U.S. Virgin Islands, Northern Mariana Islands and American Samoa). These warm, high-humidity locations promote the growth of Aspergillus
Devices
FDA has released updated information on the adverse event information from the first monthly spreadsheet Bayer is required to submit to the agency on its Essure birth control device. An agency notice (includes a link to the spreadsheet) says Bayer is required to submit the spreadsheets under a 4/24
Devices
FDA has approved a Guardant Health PMA for the Guardant360 CDx assay, the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell
Devices
Becton Dickinson (BD) is predicting a six-month delay in submitting a 510(k) for modifications to its troubled Alaris infusion pump. On a recent earnings call, BD president Tom Polen told analysts that the 510(k) should be filed in late March of 2021, which is about six months
Devices
FDA has cleared a Joimax PMA for its Intracs, an electromagnetic navigation tracking and control system, which the company says allows spinal procedures to be carried out with minimal X-ray control. Joimax says all of the device's instruments and scopes can be tracked and navigated with sensors,
Devices
FDA will hold an 8/12 virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-Cov-2. An agency notice says the purpose of the town hall is to help answer technical questions about the development and validation of tests
Devices
FDA has cleared a Surmodics 510(k) for its Sublime Radial Access 0.014 Rapid Exchange percutaneous transluminal angioplasty dilatation catheter. The device allows below-the-knee access through a transradial approach by providing a long working length (250 cm), according to the company. Outer balloon diameters range from 2.
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-A Ti Anterior Lumbar Spacer System, intended for use for anterior fusion procedures. The company says the device comes in multiple footprint sizes and in various heights to accommodate individual patient anatomies and pathologies to promote fusion. It features
Devices
CME America has recalled its BodyGuard Infusion Pump System because the device may have a slower than expected delivery of medication (under-infusion), faster than expected delivery of medication (over-infusion) or a delay in therapy. A recall notice says the reason for the infusion errors is not known. “Depending
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Somatom On.site, a mobile head computed tomography scanner that is intended to scan critically ill patients in the intensive care unit while remaining in bed. The company says the device features an easy scan setup, fast workflow, and integrated
Drugs
The Biotechnology Innovation Organization (BIO) says it supports FDA efforts to modernize its data strategy to ultimately transform the way data is shared, analyzed, and used for regulatory purposes. Commenting in advance of an agency public meeting on the topic, BIO says it will be important to remember that just
Devices
FDA has cleared a Biotricity 510(k) for its Bioflux Software II System. The product is engineered to improve workflows and reduce electrocardiogram (ECG) analysis time from five minutes to 30 seconds, the company says. The Bioflux monitors and transmits an ambulatory patient’s ECG information. It also features “advanced
Devices
HHS secretary Alex Azar 8/4 praised FDA commissioner Stephen Hahn for developing alternative regulatory pathways that could be used to obtain face masks from foreign countries in the early days of the Covid-19 pandemic. Appearing on “Mornings with Maria” on Fox Business, Azar responded to a Wall Street