Devices
FDA has cleared a VivaLnk 510(k) for the Fever Scout, a soft, wearable thermometer that continuously measures a person’s temperature. The device offers parents and caregivers the flexibility to continuously and remotely monitor a child or patient’s fever using a smartphone or tablet. The thermometer comes with
Devices
FDA has cleared a PTS Diagnostics 510(k) to expand the top range for measurement of HDL cholesterol to 120 mg/dL (3.1 mmol/L) for the company’s PTS Panels lipid panel test strips. The strips now have a measurement range of 20 to 120 mg/dL (0.
Devices
Attorney James Beck (Reed Smith) says a North Carolina federal court has addressed a Catch 22 that existed in the preemption of state tort claims against PMA medical devices. Writing in an online blog post, Beck says that to survive preemption, plaintiffs suing the manufacturers of PMA medical devices have
Drugs
Recent Warning Letters show that document control and data integrity (as well as complaint handling and corrective and preventive actions) remain key concerns of FDA investigators, according to an analysis by AssurX. “Today, FDA cGMPs and ISO standards require a document control system that demonstrates product safety and reliability,” the
Devices
FDA has granted an extension for soft contact lens labelers to comply with the requirements of the Unique Device Identification system. This is the third extension granted to the soft contact lens industry. The extension is effective until one year after FDA: 1) develops and fully integrates a technical solution
Devices
FDA has cleared an ETS Wound Care 510(k) for the Mirragen Advanced Wound Matrix for use in treating acute and chronic wounds. The resorbable borate glass matrix device comprises fibers and beads proven to be effective in wound care management, according to the company. It is designed to be
Devices
FDA has cleared a Providence Medical Technology 510(k) for the standalone use of the Cavux Cervical Cage-L System. The device is manufactured from medical grade titanium and available in a variety of sizes. It offers proprietary “grit-blasted and acid-etched surfaces,” a large space for allogenic and
Devices
FDA has cleared a Qiagen 510(k) for its Ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) for use as a qualitative in vitro diagnostic test for detecting JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood, which is found in nearly all patients with Polycythemia Vera
Devices
A key component of having a successful de novo submission to CDRH for neurological devices is requesting a pre-submission meeting (see guidance), according to a transcript of a 3/22 webinar for developers and sponsors of such devices automatically placed in Class 3 after (XXX DELETE XXX)a “not
Devices
Merit Medical has begun a Class 1 recall of its Prelude Short Sheath Introducer, which is used to guide the placement of catheters, grafts, and other medical devices into the veins and arteries. The recall is related to a manufacturing defect which may cause the tip to separate from the
Devices
An Emergo Group online post says that proposed Trump administration user fee increases “would disproportionately impact smaller medical device companies, as these firms make up the majority of the U.S. medical device industry.” The post notes that Congress must approve fees and thus companies may not have to face
Devices
FDA has issued a training video to help mammography facilities and their staffs better understand new Mammography Quality Standards Act inspection review questions dealing with mammography image quality. CDRH Division of Mammography Quality Standards director Helen Barr says in her introduction to the video’s mock inspection scenario that image
Devices
FDA has cleared a RenovoRx 510(k) for its RenovoCath adjustable dual-balloon infusion catheter to include “delivery of chemotherapeutics.” The device isolates segments of the peripheral vasculature, allowing physicians to deliver therapeutic agents in a more targeted approach. “Studies show that the targeted delivery of chemotherapy may allow for
Devices
CDRH has released a statement of what it accomplished in 2016 toward three 2016-17 strategic priorities — establishing a national evaluation system for medical devices, partnering with patients, and promoting a culture of quality and organizational excellence. The document shows supporting actions the Center took for each of the priorities
Drugs
The Arizona legislature has approved the Free Speech in Medicine Act that authorizes drug and medical device companies to communicate truthful off-label treatment information to medical professionals. The bill was supported by the Goldwater Institute, which also has promoted state and federal “right-to-try” legislation. The institute reports
Devices
FDA has cleared a NuVasive 510(k) for the CoRoent Small Interbody System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. The interbody cage is manufactured from polyether ether ketone-Optima that is intended to provide stabilization of the spinal motion segment while fusion takes
Devices
FDA has cleared a Bodycad 510(k) for its Bodycad Unicompartmental Knee System, a joint reconstruction implant system. The device is designed to “optimize personalized restoration of the patient's unique anatomical features and kinematics,” the company says. “The system is based on proprietary 3D rendering of medical images
Devices
Researchers at the Massachusetts Institute of Technology and Boston Children’s Hospital say they have identified a signaling molecule that is key to the process of “fibrosis” in which medical devices implanted in a body for drug delivery, sensing, or tissue regeneration become surrounded by a wall of dense scar
Devices
House Energy and Commerce Committee lawmakers from both sides of the aisle urged Congress and the Trump Administration 3/28 to reauthorize medical device user fees for another five years before the program expires 9/30. During a hearing, CDRH director Jeff Shuren painted a rosy picture of an improving
Devices
FDA has approved an iCAD PMA for its PowerLook Tomo Detection device, a concurrent-read computer aided detection product for digital breast 3D tomosynthesis. “PowerLook Tomo Detection improves radiologists’ efficiency by automatically analyzing each tomosynthesis plane and identifying suspicious areas,” the company says. “The suspicious areas are naturally blended onto
Devices
Phillips Healthcare has recalled its HeartStart MRx Monitor/Defibrillator due to battery and electrical issues. The device is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to those with sudden cardiac arrest. An FDA recall notice says that the battery and electrical connection
Drugs
Eli Lilly says it will invest $850 million in its U.S. operations in 2017 to expand its U.S. research laboratories, manufacturing sites, and general and administrative areas. “The investments are being driven by demand for Lilly products, as well as its robust pipeline of potential medicines in development