Devices
FDA has approved a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is designed to improve implantation procedures for endovascular treatments. The device features a 4-French low-profile delivery system that is intended to decrease the risk of access site complications and reduce the
Devices
Philips says it is undergoing discussions with the Department of Justice (DoJ) on behalf of FDA about the proposed terms of a consent decree involving the company’s troubled Respironics unit and its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. In late April, the
Devices
Medical device maker Biotronik has agreed to pay $13 million to resolve allegations that it violated the False Claims Act by causing false claims to be submitted to Medicare and Medicaid by paying kickbacks to physicians to induce their use of the companys’s implantable cardiac devices, such as pacemakers
Devices
Baxter Healthcare has recalled (Class 1) its Abacus software application due to a risk that final printed bag labels for compounded mixtures may contain incorrect information. The software performs calculations for compounding liquid doses of medications. “When connected to a compounder that mixes these doses according to the calculation, the
Drugs
FDA has released a draft guidance on the expanded use of remote regulatory assessments (RRAs) beyond the Covid-19 pandemic to assess an FDA-regulated establishment and its records to determine compliance in lieu of conducting a physical inspection. The agency notes that RRAs will be an additional regulatory tool
Devices
FDA has posted an updated final guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database (GUDID) Requirements for Certain Devices” that outlines a 75-day extension of the agency’s expected compliance date. The document notes
Drugs
Three Syneos Health executives say there are six things FDA could do to better improve representation in clinical trials. Writing in a Stat News online opinion column, the three praise the agency’s guidances issued over the last 25 years and say the recent 4/2022 guidance is a welcome
Devices
FDA has cleared a BioCircuit Technologies 510(k) for its nerve repair device, Nerve Tape, a sutureless option for surgical repair of transected nerves. The device is intended for use in peripheral nerve injuries, the company says. The biologic wrap with integrated microhooks is designed to “bind firmly, safely, and
Devices
In its latest safety communication update on using a Renuvion/J-Plasma device for certain esthetic procedures, FDA says it cleared 7/15 the Renuvion APR Handpiece for use in subcutaneous dermatological and esthetic procedures to improve the appearance of lax skin in the neck and submental region. The update
Devices
While the FDA user fee reauthorization has hit some roadblocks on Capitol Hill (see earlier story), the Advanced Medical Technology Association (AdvaMed) is urging the House and Senate to come to terms on a reauthorization package that includes diagnostic reform provisions that were approved by the Senate Health, Education, Labor
Devices
FDA has classified as Class 1 a Smiths Medical recall of its Medfusion 3500 and 4000 Syringe Infusion Pumps due to eight software malfunctions. The malfunctions may cause serious harm or death to patients from under- or over-infusion, or delays in medication delivery, according to a recall notice. The
Devices
FDA has issued a safety warning about the use of certain brands of ultraviolet (UV) wands because the devices may expose users and any nearby people to unsafe levels of ultraviolet-C radiation. The warning says that such exposure may cause injury to the skin and eyes after a few
Devices
FDA has cleared a Neuronetics 510(k) for a new indication for its NeuroStar Advanced Therapy for Mental Health device, a transcranial magnetic stimulation system, for treating anxiety symptoms for adult patients who suffer from major depressive disorder, also known as anxious depression. The company says the clearance relied on
Drugs
The Washington Legal Foundation (WLF) says a 7/29 HHS Office of Inspector General (OIG) advisory opinion rejecting a proposal to permit pharmaceutical and medical device industry sponsorship of a continuing education program for healthcare providers “could have significant implications for how life sciences companies contribute towards continuing education programs
Devices
FDA has granted breakthrough device designation for the Roche Elecsys Amyloid Plasma Panel that detects and measures Alzheimer’s disease biomarkers in blood plasma to indicate the need for further confirmatory testing for the disease. The company says it is the first in-vitro diagnostics manufacturer to receive this designation
Devices
FDA has added two updates to its Supplies of Medical Devices for Covid-19 Frequently Asked Questions Web page. The first update adds information about how the agency determines it is appropriate to remove a product code from the device shortage list, and the second tells what FDA is doing
Devices
FDA has granted de novo marketing authorizations for Apollo Endosurgery and its Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx systems for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision. The devices are intended to be used in adults with obesity with a body mass index between
Devices
CDRH is seeking feedback on its new eSTAR and eCopy electronic submission process for 510(k) and De Novo device submissions. Effective 7/18, existing users of the Center’s Customer Collaboration Portal’s progress tracker will be able to try out the process and provide user feedback on the
Devices
FDA has cleared an Eko 510(k) for its Eko Murmur Analysis Software (EMAS) for detecting and characterizing murmurs found in adults and pediatric patients. The smart stethoscope can “identify and differentiate between innocent and structural heart murmurs indicative of valvular heart disease,” the company says. Valvular heart disease is
Devices
An FDA safety communication is advising that testing for monkeypox virus should use swab samples taken directly from a lesion (rash or growth). “The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing,” the safety notice
Devices
FDA is requesting input on patient safety, including best practices to promote patient safety, education, and competency, associated with medical software functions that are excluded from the medical device definition by the 21st Century Cures Act. An agency notice says the input will help it develop a report on the
Devices
FDA has cleared a Medtronic 510(k) for its UNiD Spine Analyzer v4.0 planning platform, which includes a new “Degen Algorithm” for degenerative spine procedures. The algorithm uses machine learning to assist surgeons with planning and personalizing procedures for patients undergoing lower lumbar spine surgery, according to the company.