Devices
FDA has cleared a Tangible Science 510(k) for its daily disposable silicone hydrogel contact lens coated with a modified formula of Tangible Hydra-PEG, which is intended to improve lens wettability and deposit resistance. The lens utilizes a “variation designed to enhance the surface of daily wear lenses,” the
Devices
FDA has issued a guidance, User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications, to identify (1) the types of PMAs and BLAs subject to device user fees; (2) exceptions to user fees; and (3) actions that may result in refunds of user fees that have
Devices
FDA has classified as Class 1 a GE Healthcare recall of its CareScape R860 Inspiratory Safety Guard, a breathing accessory designed for use with the Carescape R860 Ventilator. The ventilator provides mechanical ventilation and breathing support to infants, children, and adult patients, and the safety guard is designed for use
Devices
Olympus Medical Systems and a former senior executive in Japan pleaded guilty 12/10 in Newark, NJ federal court for failing to file required adverse event reports involving its duodenoscopes and associated infections, and continuing to sell the devices knowing the likely failures, according to a Justice Department release. U.
Drugs
Former FDA associate commissioner Peter Lurie, now president of the Center for Science in the Public Interest, and New York University journalism professor Charles Seife are suing HHS, FDA, and the National Institutes of Health in an effort to overturn their rule purporting to relieve medical researchers of their legal
Devices
More than 140 industry and advocacy groups are urging Congress to permanently repeal the medical device tax before the end of this year. The tax is set to be reinstated in 2019. “Full repeal of the device tax would mean that the medical technology industry can continue innovating new approaches
Devices
AdvaMed has identified guidance documents that FDA should prioritize in its fiscal year 2019 plan on proposed documents to be developed. In comments to the agency, AdvaMed recommends that FDA finalize several of the draft guidances that it has issued within the last year. For example, the group says the
Devices
FDA has cleared an iCAD Inc. 510(k) for its ProFound AI, a cancer detection software solution for digital breast tomosynthesis that relies on artificial intelligence (AI). The clearance is based on positive clinical results from a large reader study completed earlier this year. The research was performed with 24
Devices
FDA has cleared a Meridian Bioscience 510(k) for its new Alethia CMV Molecular Amplification Test. This assay is designed to detect congenital cytomegalovirus (cCMV) infection in newborns from a saliva sample. It is the first qualitative test in a molecular amplification format cleared for cCMV testing in newborns, the
Devices
Medtronic says it initiated a field corrective action for its Puritan Bennett 980 ventilator series 9/19 that FDA has designated as a Class 1 recall. A company announcement says the corrective action is a software update to address customer feedback. It says the software updates the external USB drive
Drugs
FDA has issued a draft guidance, In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products, to describe considerations for development and labeling of companion diagnostic devices to support the indicated use of multiple drug or biologic oncology products when appropriate. The document includes factors
Devices
FDA commissioner Scott Gottlieb, CDRH director Jeffrey Shuren, and Gottlieb chief of staff Lauren Silvis say there is a need for a unified approach to the regulation of in vitro clinical tests to protect patient safety, support innovation, and keep pace with the rapidly evolving technology that is helping find
Devices
FDA has cleared a POPS! Diabetes Care 510(k) for its POPS! one Blood Glucose Monitoring system, a digital health system that combines a user’s phone with a coaching app and a small, portable, and integrated glucose monitor. “People who use the system are also able to review their
Devices
FDA has approved Olympus’ Spiration Valve System (SVS) for treating severe emphysema, a progressive form of chronic obstructive pulmonary disease (COPD). Approval was based on data from the EMPROVE clinical trial demonstrating that patients treated with the SVS “benefited from statistically significant and clinically meaningful improvements in lung function and
Devices
FDA has cleared a Subtle Medical 510(k) for the SubtlePET, an artificial intelligence (AI)-powered technology that allows hospitals and imaging centers to enhance images from faster scans. The company says its AI solution “enables completion of more exams in a day compared to conventional PET imaging without the
Devices
FDA has cleared a Bausch & Lomb 510(k) for its Ultra Multifocal for Astigmatism contact lens, a monthly silicone hydrogel lens. The device was designed to be fit during the initial contact lens exam, according to the company. The lenses will be available to eye care professionals and their
Devices
A 5/7-5/10 FDA inspection at MiBo Medical Group, Dallas, TX, found Quality System Regulation violations in the firm’s manufacturing of the MiBo Thermoflo. An 11/20 Warning Letter says specific violations were: * failing to establish procedures for design control; * failing to establish procedures for corrective and
Devices
FDA says it has formally recognized the genetic variant information in the Clinical Genome Resource consortium’s ClinGen Expert Curated Human Genetic Data database as a source of valid scientific evidence that can be used to support clinical validity in premarket submissions. FDA says this is a significant step forward
Devices
FDA says CDRH is making progress in its strategic priority to develop collaborative communities where stakeholders can work together to achieve common objectives and outcomes, solve shared challenges, and leverage collective opportunities in an environment of trust, respect, empathy, and openness. An online update says CDRH has as a key
Devices
FDA has issued a De Novo Classification Proposed Rule that, when finalized, will establish procedures and criteria for the de novo classification process and become part of the Medical Device Classification Procedures. The document says the new requirements “are intended to ensure the most appropriate classification of devices consistent with
Devices
AdvaMed has commented on FDA’s recent draft guidance on “The Special 510(k) Program,” suggesting that the document’s “proposed text may cause unintended consequences and unnecessarily restrict changes in certain device types from being reviewed through a Special 510(k), even though there are well-established methods with
Devices
FDA has approved a Medifocus PMA supplement for new labeling for its Prolieve Transurethral ThermoDilatation Therapy based on the results from the company’s benign prostatic hyperplasia (BPH) post-approval study, which showed durable and lasting clinical benefits for at least five years of follow-up. The study involved 225