Devices
FDA has updated its Web site to include an annual analysis of medical device reports involving Bayer’s now-withdrawn Essure contraceptive implant that were received from 11/4/2002 to 12/31/2020. Last year, the agency received 16,086 medical device reports related to Essure, an 6.6%
Devices
FDA is alerting health care providers and laboratory staff about false positive results which can occur with the Roche Molecular Systems’ cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test that is used on the cobas Liat System. The false positive results might be related to the assay
Devices
Combat Medical Systems has recalled its Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, and Fresh Whole Blood Donor Set due to possible broken or bent needles. The convenience kits under recall are used by military medical personnel to get
Devices
FDA has cleared a Baxter International 510(k) for its next-generation Artificial Kidney 98 dialysis machine, which is designed to be a portable system to administer hemodialysis treatments. The company says the device offers encrypted, two-way connectivity, which enables the system to pull prescriptions directly from an electronic
Devices
FDA has cleared a Qardio 510(k) for its QardioCore ambulatory electrocardiogram (ECG) device for holter monitoring applications, including its use with QardioMD, a cloud-based remote patient monitoring application. The device is intended to capture continuous ECG rhythms. It also displays full-disclosure ECG reports and may be used
Devices
Former FDA lawyer Laurie Clarke has joined TSG Consulting as vice president and principal of its medical device regulatory practice. The company says Clarke “will lead TSG Consulting’s established medical device regulatory team, as well as collaborate with medical device advisory and product development teams at sister company Sargentia,
Devices
Attorney Jim Shehan (Lowenstein Sandler) says FDA managed to largely fulfill its core responsibilities of ensuring compliance and helping bring new products to market in 2020 despite having to cope with the Covid-19 pandemic. Writing in a Med Device Online guest column, Shehan says that based on the 2020
Devices
FDA has cleared an Akesis 510(k) for the Akesis Galaxy RTi, an advanced gamma stereotactic radiosurgery system (SRS) with continuous 360-degree rotational technology and real-time, in-line imaging. The company says the imaging system is on a rigid ring-gantry at the treatment plane, eliminating the need
Devices
FDA has issued a table to be used with its 11/2020 immediately-in-effect guidance Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the Federal Food, Drug, and Cosmetic Act During the Covid-19 Public Health Emergency. The table contains the agency’s recommendations
Devices
FDA has cleared a Brain Scientific 510(k) for its NeuroCap device, an advanced electroencephalogram (EEG) electrode array used to obtain rapid EEGs in routine clinical and research settings. The disposable pre-gelled EEG headset has 22 electrodes and 19 active EEG channels. “Pre-gelled, fixed electrode locations eliminate time
Devices
CDRH has announced a 4/13 workshop on how medical device developers can use consensus standards in premarket submissions. It will also discuss the agency’s Accreditation Scheme for Conformity Assessment (ASCA) Pilot, which is intended to improve the efficiency of conformity assessment in device reviews. Each session will provide
Devices
FDA has cleared a Cochlear Ltd. 510(k) for its new Cochlear Baha 6 Max Sound Processor for improving hearing outcomes for people with single-sided deafness, conductive or mixed hearing loss. The device is considered the smallest 55 dB sound processor, and it includes the ability to audio stream
Devices
FDA has issued a device safety alert on thermal imaging systems intended to measure human body temperature because improper use could provide inaccurate temperature readings. These devices (telethermographic systems, infrared thermographs, thermal cameras, and fever cameras) are being used for temperature assessments and triage of individuals for elevated temperatures in
Devices
FDA has issued Cue Health an emergency use authorization for its Cue Covid-19 Test for home and over the counter use. The molecular nucleic acid amplification test is the first molecular test authorized for at-home use without a prescription, an agency release (XXINSRT LINKXX) says. It is intended
Devices
FDA has granted MedAlliance a breakthrough designation for its Selution SLR, a sustained drug-eluting (sirolimus) catheter for treating atherosclerotic lesions in native coronary arteries. FDA awarded the designation for improving luminal diameter in patients with atherosclerotic lesions in native coronaries, the company says. MedAlliance says the technology involves “unique
Devices
Two Morrison & Foerster Life Sciences attorneys say FDA is slowly acting on its commitment to developing a regulatory framework for artificial intelligence/machine learning (AI/ML)-based software as medical devices, but still has not provided any consistent standards. In an online analysis of the agency’s steps, the
Devices
The New Jersey Superior Court has reversed and remanded for new trials two consolidated cases in which plaintiffs sought damages from Ethicon and Bard over pelvic mesh medical devices. The court opinion says the devices were surgically implanted in the female defendants in each case and severe adverse complications ensued
Devices
Taxpayers Protection Alliance senior fellow Ross Marchand says FDA “must reverse its misguided aversion to life-saving coronavirus tests.” Writing online in The Center Square, Marchand praises the approval of three Covid-19 vaccines but says Americans still must make do with a subpar testing regime that takes a day
Devices
FDA says its review of a Web site maintained by EnMed MicroAnalytics, Charleston, SC, determined that the firm offers Covid-19 blood sample collection kits that are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of Covid-19 in people and thus are legally medical devices. A
Devices
FDA says its review of a Web site maintained by Orvic, doing business as Webstore-USAVan Nuys, CA, determined that the firm is marketing an unapproved Covid-19 serology test that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of Covid-19, and thus is legally
Devices
FDA has cleared an Asensus Surgical 510(k) for the Senhance Surgical System and its use in general surgery procedures. “Senhance goes beyond the typical surgical robotic systems, providing surgical assurance through haptic feedback, eye-tracking camera control, and 3D visualization, and is the first platform to offer 3 mm
Devices
FDA says it has notified 25 companies they should stop producing and issuing “FDA registration certificates” that deceptively indicate FDA approval, clearance, or authorization for medical devices. CDRH Office of Regulatory Programs director Sean Boyd says the agency has seen an increase in the number of companies selling medical devices