Devices
FDA is recommending that manufacturers of breast implants incorporate a Boxed Warning and patient decision checklist into the device labeling “to better ensure certain information is received and understood by patients.” A new draft guidance, Breast Implants—Certain Labeling Recommendations to Improve Patient Communication, also recommends updated and additional labeling
Devices
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Premarket Approval of Medical Devices” (OMB Control Number 0910-0231). Premarket approval application (PMA) requirements assist in the agency’s scientific and regulatory review to ensure the safety and effectiveness of Class 3 devices. PMA requirements apply
Devices
Researchers say the FDA policy for health and wellness app regulation is ethically problematic and the agency should take much more responsibility to regulate all such apps. Writing online in the journal Bioethics, the researchers say that FDA currently does not regulate health and wellness apps that are not intended
Devices
The National Council on Disability (NCD), an independent federal agency, is calling on FDA to end its enforcement discretion and regulate laboratory diagnostic tests, and particularly noninvasive prenatal screenings, that it says have made prenatal genetic testing more commonly available to women of different ages, socioeconomic backgrounds, and health histories.
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA can resolve its “worst of all worlds” oversight of laboratory-developed tests (LDT) by standing down until Congress sets the authorized terms of the agency’s role in LDT oversight. Writing in his firm’s FDA Law Blog, Shapiro reviews the
Devices
FDA has granted Garwood Medical a Breakthrough Device designation for its BioPrax device, which is under investigation to help eliminate biofilm infections on prosthetic knee implants during early intervention procedures. The device provides a low-voltage electrical treatment to the surface of a knee implant, creating an environment that kills
Devices
FDA has cleared a Canon Medical Systems 510(k) for its Advanced Intelligent Clear-IQ Engine (AiCE) for use on the Aquilion Precision CT Scanner. The device uses a deep learning algorithm to differentiate signal from noise for computed tomography (CT) image reconstruction. Its ultra-high resolution CT provides two
Devices
FDA has cleared an Ortho Clinical Diagnostics 510(k) for the ORTHO Sera, a series of extended antigen phenotyping for use on the Ortho Vision Analyzer. The device’s extended phenotype testing covers more than 99% of the most commonly tested blood group antigens to support for patients with unexpected
Devices
Nuvectra has submitted FDA-requested data to allow the agency to complete its review of a 2017-submitted PMA for Virtis, a sacral nerve stimulation (SNS) system for treating chronic urinary retention and overactive bladder symptoms. The company recently submitted supplementary chemical composition and biocompatibility data. The company says that
Devices
AdvaMed has written to President Donald Trump asking him to support permanent elimination of the medical device excise tax as part of a proposed 2020 tax package. “The medical device excise tax is set to return on New Year’s Day 2020 — a $20 billion tax increase on the dynamic
Devices
CDRH has published a list of 27 guidances it proposes to issue during Fiscal Year 2020. The list includes 12 A-list final guidances that are prioritized for FY 2020 publication; nine A-list draft guidances; four B-list final guidances to be issued as resources permit during FY 2020;
Devices
Johnson & Johnson and its Ethicon subsidiary have agreed to pay $116.86 million to 41 states and the District of Columbia to resolve allegations that they violated state consumer protection laws by misrepresenting the safety and effectiveness of transvaginal surgical mesh devices and also failed to sufficiently disclose risks
Devices
FDA has cleared a Fidmi Medical 510(k) for its low-profile enteral feeding device. The gastrostomy device has a replaceable inner tube which can be changed by patients without the need to re-enter the healthcare system for replacement procedures, the company says. The device is designed to eliminate
Devices
HHS’s Office of Inspector General (OIG)says it is assessing FDA’s medical device postmarket surveillance activities. “As the information that the FDA receives about medical device safety and effectiveness is increasingly gathered in the postmarket setting, it is more important than ever that FDA’s postmarket safety surveillance
Devices
A 10/2 CDRH Webinar offered recommendations for improving dental device 510(k) submissions. Office of Health Technology One acting assistant director Michael Adjodha said the “refuse-to-accept” rate for dental devices in the first round of review is above 80% and involves several issues that were discussed in
Devices
FDA has cleared a Subtle Medical 510(k) to market SubtleMR, an artificial intelligence image processing software that uses “denoising and resolution enhancement” to improve image quality, according to the company. It uses “proprietary deep learning algorithms” to improve technology with existing scanners, it says. The software improves the quality
Drugs
With Canada and the European Union releasing much of the data companies submit when seeking approval for a new drug, biologic, or medical device, pressure is being placed on FDA to change its stance that says that such information contains confidential trade secrets and can’t be released. National Public
Devices
FDA has made available a transcript of a 9/10 Patient Engagement Advisory Committee that recommended the agency develop standards for device companies to use when communicating any cybersecurity concerns to patients. Panel members recommended that the format for cybersecurity messages to patients should include e-mails, Web postings, social
Devices
A 5/1-5/6 FDA inspection at Denterprise International, Ormond Beach, FL, found Quality System Regulation and other violations in the firm’s work as specification developer, manufacturer of the FlashRay dental X-ray sensor and the MobileX, Model T-100, dental X-ray system. A 10/9 Warning
Devices
FDA has cleared an OssDsign 510(k) to market its Cranial PSI Accessories, which are a set of 3D-printed, patient-specific accessory devices designed to support and expand clinical use of its patient-specific cranioplasty implant already cleared by the agency. The new accessories are intended to assist neurosurgeons
Devices
FDA has cleared a Wontech 510(k) for its low level laser therapy hair loss treatment device, HairBoom Air. The device, according to the company, features 69 laser diode terminals that generates a laser treatment that is evenly spread on the scalp to activate follicle cell proliferation, increase blood flow,
Devices
FDA has cleared a Think Surgical 510(k) for the TSolution One Total Knee Application for use in total knee arthroplasty. The robotic device includes CT-based 3D pre-surgical planning software which “allows the surgeon to design and prepare, in a virtual environment, the patient’s unique knee joint