Devices
FDA has approved Grifols’ Procleix Zika Virus assay for detecting the virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion. The assay is also approved for testing plasma or serum specimens to screen other living (heart-beating) or
Devices
FDA has cleared a BioSig Technologies 510(k) for the Pure EP System, a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The device is intended for use under the supervision of licensed
Devices
FDA has granted MolecuLight de novo classification allowing marketing of its wound fluorescence imaging device, the MolecuLight i:X, which is intended to digitally capture and document fluorescence information from wounds and surrounding tissue using still images and videos in real-time. The handheld device is designed for use at
Devices
A University of Texas Medical study reported in the open access journal Cureus finds that medical device recall is not an uncommon event with the majority of products cleared for marketing through FDA’s least strenuous 510(k) process. The researchers looked at all foot and ankle devices from 2007
Devices
Responding to a request for FDA technical assistance on the Diagnostic Accuracy and Innovation Act, the agency has advanced a different framework with different statutory language that would substantially change the regulatory regime for in vitro diagnostics (IVDs), according to a blog post by attorney Jeffrey Gibbs (Hyman, Phelps &
Devices
FDA has granted de novo marketing for Natural Cycles Nordic’s Natural Cycles mobile medical application that can be used as a method of contraception to prevent pregnancy. The app contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily
Devices
Hologic’s Cynosure division has suspended marketing and distribution of its TempSure Vitalia handpiece and probe, which is used for heating vaginal tissue, due to FDA concerns regarding “vaginal rejuvenation” procedures using energy-based devices (see earlier story). Last month, FDA warned that using energy-based medical devices to perform
Devices
FDA has cleared a 7D Surgical 510(k) for the Cranial Module for use on its Machine-vision Image Guided Surgery (MvIGS) system for cranial surgery. The device uses the company’s new camera-based technology and machine vision algorithms to eliminate “long-standing frustrations with legacy surgical navigational platforms,
Devices
Spacelabs Healthcare has recalled the Arkon Anesthesia Delivery System due to the device going into a “failed state,” which causes the mechanical ventilation function to stop working. The device is intended for use in hospitals and operating rooms, and it delivers oxygen, air, and nitrous oxide in a controlled manner
Devices
Vyaire Medical has recalled its AirLife Resuscitation Device due to a manufacturing error which may cause extra plastic material in the oxygen output connection that may reduce or block the flow of oxygen to the patient. The blocked connection may result in a delay in or inability to provide necessary
Devices
FDA says it is extending from 9/24/18 to 9/24/19 the compliance date for GUDID (Global Universal Device Identifier Database) submission requirements of device constituents of co-packaged combination products assigned to CDER for premarket review. A CDRH letter to manufacturers says the Center is deploying enhancements
Devices
FDA has cleared an Aidoc artificial intelligence solution for radiologists to flag acute intracranial hemorrhage cases in head computed tomography scans. Aidoc’s solution analyzes medical images directly after a patient is scanned and notifies the radiologist of suspected hemorrhage cases to assist with prioritization of potentially life-threatening cases,
Devices
FDA has issued a “not approvable” letter to PneumRx for its PMA application for Elevair Endobronchial Coil System for treating people with severe emphysema. On 6/14, FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee voted 7 to 5 in favor of the device’
Drugs
The Stericycle Recall Index says that pharmaceutical recalls dropped 27% to 77 in the second quarter of 2018. That was lower than in six of the last eight quarters. Recalled units dropped 95% to nearly 15.9 million, lower than four of the last six quarters, the report says, but
Devices
FDA has cleared an iCAD 510(k) for its latest artificial intelligence software solution — PowerLook Density Assessment Version 3.4. The software is compatible with iCAD’s digital breast tomosynthesis platform on both GE and Hologic systems. “Breast density plays a critical role in both risk assessment and accuracy, as
Devices
FDA is reminding healthcare providers that tests to detect ruptures of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions. An agency letter says that healthcare providers using rupture of membranes (ROM) tests should be aware of the test limitations shown in
Devices
Qiagen Sciences has recalled the AmniSure ROM Test due to a potential manufacturing defect causing the control line to not display. “A lack of a control line may lead to misinterpretation of test results,” a recall notice says. “The test is designed to display one line (control line) if the
Devices
AdvaMed says that a provision in an FDA Q-Submission Program draft guidance extending from 21 to 70 days the agency’s feedback timeline for submission issue requests (SIRs) received after the 30-day deadline after a marketing submission hold “risks counterproductive results.” In its comment letter, AdvaMed says that
Devices
CBER says the Web site testkitmart.com is promoting two HIV tests — the iCare HIV 1&2 Rapid Screen Test and the iCare One-Step HIV 1/2 Oral Fluid Test — in the U.S. when the tests are not approved for sale here and have not received IDE
Devices
FDA has approved magnetic resonance-conditional labeling for Envoy’s Esteem hearing implant, the only middle ear implant to receive approval for such labeling in both 1.5 and 3.0 Tesla scanning environments. The company says surgeons and audiologists who have worked closely with hearing implants have seen as
Devices
FDA has cleared a Cianna Medical 510(k) to broaden the indication of its SCOUT reflector for use in localization of soft tissue. “The SCOUT System has been in use for wire-free breast tumor localization since 2016 and has been proven in over 42,000 procedures in more than
Devices
FDA has cleared a Strata Skin Sciences 510(k) for its Multi-Micro Dose tip accessory for its proprietary Xtrac 308nm excimer laser. The accessory is indicated for use in conjunction with the laser to filter narrow band-UVB light at delivery in order to calculate and individualize the maximum