Devices
CDRH wants to improve medical device post-market data by improving hospital (user) reporting of adverse events. Following high-profile device safety issues occurring in hospitals in 2015, such as the spread of uterine cancer from the use of morcellators or the spread of infections associated with contaminated duodenoscopes, FDA
Devices
FDA has cleared an Ortho Clinical Diagnostics 510(k) for the Ortho Vision Max, an automated blood analyzer for high-volume transfusion medicine laboratories. The device was developed for labs conducting greater than 50 types and screens per day, and it also supports more complex immunohematology testing, such as serial
Devices
FDA is urging the public and industry insiders to report regulatory misconduct against medical device manufacturers or individuals marketing medical devices who may be violating the law. Reporting these allegations “can help the FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as
Devices
FDA and CMS have announced that their ongoing medical device “parallel review” pilot program will be fully implemented and extended indefinitely. Parallel reviews allow both agencies to review information about a medical device concurrently, rather than sequentially, while continuing to make their premarket review and coverage decisions consistent with their
Devices
Sen. Al Franken (D-MN) continues to monitor FDA’s handling of late medical device adverse events from manufacturers amid a growing controversy that new reporting mechanisms and guidelines are needed. A recent Minneapolis Star Tribune article revealed the agency’s use of a “retrospective summary reporting” program, under which
Devices
FDA has approved a Roche PMA for the cobas MPX test for use on the cobas 6800 and 8800 Systems. The test enables donor screening laboratories to “apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the spread
Devices
Teleflex Medical has begun a Class 1 recall of its Willy Rusch Tracheostomy Tube Set which is used for cannulation of tracheotomized patients, particularly for narrow tracheostoma and narrow-lumen tracheas. A recall notice says the connector may disconnect from the tracheostomy tube during use. At this time, the cause
Devices
FDA says it is recommending that healthcare providers stop using Multidata Systems radiation therapy devices because they have not received 510(k) clearance from the agency. A notice to radiation oncologists, medical physicists, dosimetrists, and radiation therapists says that for at least two of the company’s devices, the agency
Devices
A supplement to a 3/31 citizen petition says it provides “evidence that the resin Boston Scientific Corp. (BSC) is currently using to manufacture its transvaginal mesh product (1) is not Marlex HGX-030-01, (2) is not supported by evidence proving its safety, and (3) cannot be characterized as
Devices
FDA has cleared an Avinger 510(k) for the Pantheris Lumivascular atherectomy system for use in Peripheral Artery Disease (PAD) patients for therapeutic and diagnostic purposes. The expanded indication clarifies that, in addition to treatment of PAD, Pantheris may be used by physicians to identify the vessel lumen and wall
Devices
The Biotechnology Innovation Organization (BIO) says it welcomes the release of two FDA draft guidances on regulating next generation sequencing (NGS) tests. Commenting specifically on the guidance dealing with use of public human genetic variant databases to support clinical validity for next generation sequencing-based in vitro diagnostics, BIO says
Devices
Medtronic Neurovascular Products has recalled certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. The reason for the recall is the potential for the devices’ polytetrafluoroethylene
Devices
Three stakeholder trade associations are asking FDA to clarify some aspects of a draft guidance on principles for co-development of an in vitro companion diagnostic device with a therapeutic product. The Biotechnology Innovation Organization says it supports the agency’s efforts to provide a practical regulatory guide for sponsors
Drugs
President Obama’s “Cancer Moonshot” initiative has released a task force report on implementation plans. One strategic goal, it says, is to catalyze new scientific breakthroughs by “fostering interdisciplinary approaches for elucidating the biological mechanisms underlying cancer onset and treatment; aligning research and care as a seamless and iterative process;
Devices
FDA has cleared a Teleflex 510(k) to market its Arrow Midline with Chlorag+ard Technology, an anti-thrombogenic and antimicrobial peripheral venous catheter designed to minimize common midline catheter complications such as catheter intraluminal occlusion, thrombus accumulation and microbial colonization on the catheter surface for a minimum of 30
Devices
FDA has cleared a Royal Philips 510(k) for the S4-1 cardiac transducer for Lumify, a“smart-device” diagnostic ultrasound solution. The pocket-sized and lightweight device offers high-resolution 2D image quality and exam pre-sets to allow clinicians to quickly triage and assess their patients, the company
Devices
Leonhard Lang has begun a Class 1 recall of its multi-function defibrillation electrodes DF29N because they will not work with Welch Allyn’s automatic external defibrillator model AED 10. AEDs are used to deliver lifesaving electrical shocks to people with sudden cardiac arrest. A recall notice says the electrodes
Devices
FDA has published an International Medical Device Regulators Forum guidance, Software as a Medical Device (SaMD): Clinical Evaluation, in an effort to establish a “common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness, and performance of software intended for medical purposes” as defined in a
Devices
FDA has approved a Medtronic PMA for its cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla magnetic resonance imaging (MRI) machines. The approval covers the company’s SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators and
Devices
FDA has updated a June safety communication calling attention to infections associated with Stӧckert’s 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) and to add steps that healthcare providers and facilities can take to mitigate patient risk. Over the past few months, the
Devices
Responding to an FDA draft guidance on use of standards in agency regulatory oversight of next generation sequencing-based in vitro diagnostics used for diagnosing germline diseases, the American Medical Association (AMA) reiterates its assertion that FDA lacks statutory authority to regulate any laboratory-developed tests, including those at issue,
Drugs
In response to increasing data integrity citations in Warning Letters and inspections, FDA has signed an agreement with CluePoints to develop a data driven software tool to detect data anomalies indicative of fraud, misconduct or sloppiness. Earlier this year, the agency released a draft guidance, Data Integrity and Compliance with