Devices
Writing in a JAMA Internal Medicine research letter, Israeli researchers say that despite a 2014 FDA guidance, women have been underrepresented in medical device clinical trials. The researchers say that CDRH recently issued a strategic plan for improving women’s representation in medical device trials. “We found that device trials
Devices
FDA has cleared two Abbott 510(k)s for over-the-counter continuous glucose monitoring (CGM) systems Lingo and Libre Rio, which are based on the company’s FreeStyle Libre CGM technology. “The newly cleared systems have been intentionally designed to meet different needs – Lingo for consumers who want to
Devices
FDA has cleared a Moon Surgical 510(k) for its Maestro surgical system. The small, adaptable device is intended to be integrated into existing clinical workflows over any laparoscopic indication, according to the company. “The system is equipped with NVIDIA Holoscan, a powerful edge computing platform that allows real-time
Devices
FDA has cleared a Genetic Signatures 510(k) for its EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow. The device uses the company’s patented 3base technology to identify eight of the most common and clinically relevant gastrointestinal parasites in a single test, from a single patient sample, according
Devices
Eight external stakeholder groups interviewed by the Government Accountability Office for its information sheet on over-the-counter (OTC) hearing aids say several issues should be monitored as the market matures—marketing, children’s use of OTC hearing aids, return policies, and gain limits (the amount of amplification added to
Devices
University of Missouri—Kansas City researchers say innovation for pediatric orthopedic devices lags substantially behind that for adult orthopedic devices. “These findings are consistent with clinical experience and the common practice of modifying adult implants for off-label use in pediatric patients,” the researchers write in the Journal of Bone
Devices
FDA has cleared a Diasorin 510(k) for its Liaison Plex Yeast Blood Culture Assay for microbiological diagnosis of bloodstream infections. The device detects 16 pathogens commonly associated with fungemia (fungal bloodstream infections). “Fungal pathogens are often seen as an emerging threat and are of great concern due to the
Devices
FDA has denied a Nautilus Glove 1/11 request for reconsideration and petition for stay of action that asked the agency to (1) reconsider its recission of 510(k) substantial equivalence for the Nautilus Nitrile Exam Gloves and permit the company to amend its 510(k) with the correct in
Devices
Medtronic is recalling (Class 1) its StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 after customer complaints about a software error that removed numbers or letters in displayed text and replaced them by a space, in either the
Devices
A 6/3-6/5/2023 FDA inspection at Trexo Robotics Holdings in Mississauga, Ontario, Canada, found that the firm manufactures the Trexo Home and Trexo Plus medical devices that are adulterated because they do not have an approved PMA or IDE in place. A just-released 2/7 Warning
Biologics
FDA commissioner Robert Califf and two agency colleagues say FDA is interested in pragmatic clinical research as a “middle path between traditional randomized clinical trials and observational evidence to inform decisions about the use of medical products after initial market approval.” Writing in a JAMA Viewpoint, the three say pragmatic
Devices
A 6/19-6/22/2023 FDA inspection at Techlem Medical Corporation in Mississauga, Ontario, Canada, found multiple Quality System Regulation violations in the firm’s manufacturing of wheeled stretchers. A just-released 12/26/2023 Warning Letter says the specific violations were: * failure to adequately establish procedures for implementing
Devices
Arrow International has recalled (Class 1) its Arrow FiberOptix Intra-Aortic Balloon Catheter Kit after receiving reports about “infrequent” device malfunctions that could result in serious health consequences. According to a recall notice, the issues may “manifest” as failure of the intra-aortic balloon to completely inflate over its full
Devices
FDA has cleared a Kenota Health 510(k) for its Kenota 1 Total IgE [immunoglobulin E] test system for the semi-quantitative detection of total IgE. Blood typically has small amounts of IgE antibodies, and higher amounts can signal the body is overreacting to allergens, Kenota Health says. The test
Devices
FDA has approved an Avita Medical PMA supplement for the Recell GO System, its next-generation autologous cell harvesting device that is intended to harnesses the regenerative properties of a patient’s own skin to treat thermal burn wounds and full-thickness skin defects. “This next-generation device significantly reduces
Devices
Researchers at Yale and Emory Universities say there is little evidence that surrogate markers used by drug companies seeking accelerated approval coincide with better disease outcomes. The study (subscription or purchase required), published recently in the Journal of the American Medical Association, looked for meta-analyses for 37 surrogate markers
Devices
OptumHealth Care Solutions is recalling (Class 1) its Nimbus II Plus infusion pumps (also known as the Nimbus II Optum Homecare Infusion) in response to a 2/21 InfuTronix recall of these devices due to multiple potential failure modes that may include battery failure, upstream blockage, system errors, drug product
Devices
The American Clinical Laboratory Association (ACLA), HealthTrackRX Indiana, and HealthTrackRX, Inc., are suing FDA in a Texas federal court to challenge the agency’s 5/6 final rule announcing its intent to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FFDCA). “Because
Devices
Medline Industries has recalled (Class 1) its Medline Sub-G Endotracheal Tube with Subglottic Suctioning after complaints were received about the device’s inflation tube detaching from the main tube. If a detachment occurs, this could result in potential moisture buildup, loss of pressure, or inability to inflate, recall notice
Devices
A bipartisan group of four senators and 11 members of the House is calling on FDA to strengthen protections for consumers with hearing loss by considering ways to inform them if they are purchasing so-called locked hearing aids. A letter to FDA commissioner Robert Califf says some hearing aid
Devices
FDA says Ostar Beauty Sci-Tech Co Ltd in Beijing Shi, China, is marketing several medical devices without marketing clearance or approval. A just-released 12/4/2023 Warning Letter identifies the three types of products that FDA says are adulterated because Ostar does not have an approved PMA or
Devices
FDA has cleared a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage. The device features a “Mimetix morphometric profile,” which was developed with digital models of the vertebrae to optimize the contact surface between implant and endplates, the company says. The system allows for fixation with