Devices
FDA commissioner Scott Gottlieb says the agency is launching a Pre-Cert for Software pilot program that embraces the principle that digital health technologies can have significant benefits to patients’ lives and to the healthcare system by facilitating prevention, treatment, and diagnosis, and by helping consumers manage chronic conditions outside
Devices
A 3/6-3/23 FDA inspection at Whitehall/Division of Acorn Engineering Co., City of Industry, CA, found violations of the Quality System Regulation and Medical Device Reporting regulation in the firm’s manufacturing of whirlpool immersion hydrotherapy devices and dry heat therapy devices, according to a 7/12
Devices
The FDA Patient Engagement Advisory Committee will hold its inaugural meeting 10/11-12. In an FDA Voice blog post, CDRH director Jeffrey Shuren and assistant director for strategic programs Kathryn O’Callaghan write that this is the first time an FDA advisory committee will focus on patient-related issues.
Devices
FDA has cleared a Luminex 510(k) for the Aries C. difficile assay, a test designed to detect both toxin A and toxin B, which may reduce the probability of a false negative result from strains that only produce toxin A, the company says. A 2015 CDC study found that
Devices
Penumbra has begun a Class 1 recall of its 3D Revascularization device because there is a risk that the delivery wire could break or separate during use. “Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve
Devices
Fujifilm has recalled all ED-530XT duodenoscopes after FDA cleared an updated design and labeling request for the device. This action will result in replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and a new operation manual, a recall
Devices
Researchers from Northwestern University and the University of Chicago say that soft tissue fillers (STFs) are safe and are often approved as Class 3 medical devices based on data from randomized clinical trials. However, they write in JAMA Facial Plastic Surgery, “an opportunity remains to strengthen the approval process, particularly
Devices
FDA has cleared a DarioHealth 510(k) for the Dario app and its use on certain Android mobile devices. The clearance allows the sale of the Dario Blood Glucose Monitoring System on the Google play store for Android devices, including Samsung Galaxy S series, Samsung Galaxy Note series and LG
Devices
FDA has cleared an Aspect Imaging 510(k) for the Embrace Neonatal MRI System, which FDA describes as the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units. It has a temperature-controlled incubator placed directly into the MRI system, minimizing
Drugs
Three industry trade groups are reiterating their opposition to a proposed FDA final rule defining the intended use of a drug or medical device based on the totality of the evidence rather than on a manufacturer’s promotional claim for the product, which is the current practice. In 7/18
Devices
FDA has approved Biotronik’s Intica DX cardiac resynchronization therapy and implantable cardioverter defibrillator system. The device eliminates the need for an atrial lead while still providing physicians with critical diagnostic information based on a true atrial signal, the company says. “Atrial diagnostics aid physicians in the early identification of
Devices
An FDA inspection at National Biological Corp., Beachwood, OH, found lack of conformity with the current good manufacturing practice requirements of the Quality System Regulations, according to a 7/11 Warning Letter. Specific violations noted on an FDA-483 included: * failing to validate a process whose results cannot be fully
Drugs
Attorney Michael Blume (Venable) says that even though the Supreme Court declined to hear the appeal of Quality Egg owners Jack and Peter DeCoster from their three-month sentence after pleading guilty to misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Justice Department briefs submitted in
Drugs
FDA has told Repros Therapeutics that its clinical development program for Proellex, an oral delivery mechanism for telapristone acetate for treating uterine fibroids, will remain on partial clinical hold based upon its review of existing liver function safety data. The agency has also indicated that the company will be required
Devices
FDA has cleared a CSA Medical 510(k) to expand the use of its truFreeze catheter offerings to include a third spray kit called RapidAV Spray Kit. “The RapidAV catheter has a material property change such that it provides the ability to shorten the time to liquid nitrogen spray by
Devices
FDA has cleared a Tyber Medical 510(k) for TyFix, an all-in-one extremity joint fixation system. The device is designed to eliminate the use of the ancillary instrumentation for a wide range of bone fixation procedures, including hammertoe correction, according to the company. In addition, the all-in-
Devices
FDA has cleared a Royal Philips 510(k) for the Philips BlueControl wearable light therapy device to treat mild psoriasis. “Clinical studies have demonstrated that the UV-free blue LED light emitted by Philips’ BlueControl wearable device induces natural, drug-free processes in the skin to significantly reduce symptoms of
Devices
FDA has released the FDA-483 issued after a 5/10-6/29 inspection at Magellan Diagnostics, North Billerica, MA. The company was the subject of a 5/17 agency warning that Magellan Diagnostics LeadCare tests systems performed on blood drawn from a vein may provide inaccurate results. An agency
Drugs
Attorney James Beck (Reed Smith) writes in an online post that while a Missouri court last year held that an FDA-approved Boxed Warning was not only inadequate but so poor as to be worthy of punitive damages, most courts have found that Boxed Warnings are adequate as a matter
Devices
A North Carolina federal court has ruled that a case involving Bayer’s Essure birth control medical device is preempted. Attorney Michelle Yeary (Dechert) writes in an online blog post that the plaintiff tried to get around traditional failure-to-warn preemption by arguing that the failure to warn was
Devices
The Washington Supreme Court has held that a medical device manufacturer has a duty to warn hospitals, and not just doctors, about the potential dangers of a device. A Washington Legal Foundation Legal Opinion Letter says the decision “represents a significant and unwarranted expansion of the duty to warn under
Devices
FDA says that it has not received any additional adverse events associated with severe bleeding and hematomas with axter International’s Vascu-Guard peripheral vascular patch during carotid endarterectomy (CEA) since the agency sent a 9/2016 letter to health care providers. Baxter conducted a recall of the device 6/