Devices
Six Sidley attorneys say that a Texas federal court’s 3/31 decision throwing out FDA’s final rule on oversight of laboratory-developed tests (LDTs) relied heavily on the Supreme Court’s 2024 Loper Bright decision that eliminated the precedent of courts deferring to agency interpretations of unclear laws.
Devices
Recent staff cuts at CDRH will likely lead to “longer review times, at least in the near term,” former CDRH director Jeff Shuren said in a 4/3 Webinar on the current challenges facing the MedTech industry, clinical investigators, and regulators. The device user fee program is shaken up by
Devices
FDA has cleared a Medivis 510(k) for its Spine Navigation platform that uses augmented reality (AR) and artificial intelligence (AI) to assist surgeons in spinal procedures. The company says the device combines proprietary computer vision algorithms, AI segmentation, real-time data analysis and advanced image processing. It also features
Devices
A 12/5-12/14/2024 FDA inspection at Rex Implants in Columbus, OH, found that the company is manufacturing and distributing the REX Mallet, rexpander devices, and Piezoimplant REX BL 2.9 system without an approved PMA or IDE application in place. A 3/12 Warning Letter says the
Devices
Bausch + Lomb has recalled all enVista intraocular lenses (IOLs) due to increasing adverse event reports of toxic anterior segment syndrome (TASS) in conjunction with these IOLs. TASS is a rare, sterile inflammation of the anterior segment of the eye (the area between the cornea and iris) that typically occurs after
Devices
An 8/12-9/5/2024 FDA inspection at Next Science LLC in Jacksonville, FL, determined that the firm is illegally manufacturing and distributing adulterated and misbranded wound gels and wound irrigation solutions. A just-released 2/21 Warning Letter says the medical devices are adulterated because the firm does
Devices
FDA has cleared a TrainHealth 510(k) for its TrainFES [functional neuromuscular stimulator] Advanced device and its use in treating people with sequelae of stroke and spinal cord injury. The device uses smart electrical stimulation that moves the paralyzed limbs of patient to increase both adherence and functional results, the
Devices
An FDA final rule regulating laboratory-developed tests (LDTs) has been vacated by a Texas federal court. Eastern Texas federal judge Sean Jordan ruled 3/31 in favor of plaintiffs American Clinical Laboratory Association and Association for Molecular Pathology, agreeing that the rule is in “excess of [FDA’s] statutory
Devices
Medtronic is recalling (Class 1) its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device. “The loose material has the potential to become dislodged and cause serious patient adverse health consequences, including injuries caused by delayed therapy, stroke, and death,
Devices
FDA has granted Visby Medical a de novo marketing clearance for its Women’s Sexual Health Test, a non-prescription at-home diagnostic test for chlamydia, gonorrhea and trichomoniasis. The single-use device includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to
Devices
FDA has cleared a Vasorum 510(k) for the Celt ACD Plus vascular closure device, its next-generation device that it says provides physicians with a visual indicator for precise placement and closure, particularly in cases where ultrasound imaging is not available. The device is available in 5F, 6F, and
Devices
Several FDA scientists who still have positions at the agency have told Reuters anonymously that the agency is likely to miss congressionally mandated user fee review deadlines for medical devices. The news service’s exclusive report says the scientists have been told to shelve easier applications and stop providing early
Devices
The Justice Department says it has reached a settlement agreement with New Hampshire medical device manufacturer Prometheus and its owner, Richard Poore, to pay the government $550,000 to resolve False Claims Act allegations. A suit against the company and Poore alleges that they caused healthcare providers to bill Medicare
Devices
A 10/17-1/24/2024 FDA inspection at Exer Labs in Denver, CO, determined that the firm is illegally marketing its Exer Scan. A just-released 2/10 Warning Letter says the firm does not have an approved PMA or IDE application for its device and also did not
Devices
FDA has updated with 2024 information the Web page it maintains on issues with the withdrawn Bayer Essure implanted birth control device. FDA says it received 803 medical device reports on Essure in 2024, significantly lower than the 3,626 reports received in 2023. It was the lowest number of
Devices
FDA has issued Nyxoah an approvable letter on its PMA for the Genio system, a neuromodulation device for treating obstructive sleep apnea (OSA). The agency letter said the device could be approved once issues with the company’s manufacturing facilities, methods and controls are satisfactorily addressed and reviewed. “The FDA
Devices
Covidien has recalled (Class 1) its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula due to safety concerns about a component potentially becoming disconnected. The device has a flange that “may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue
Devices
A 10/21-11/7/2024 FDA inspection at Dexcom in San Diego, CA, and a 6/10-6/14/2024 inspection at the firm’s facility in Mesa, AZ, found seven Quality System Regulation violations in its manufacturing of G6 and G7 continuous glucose monitors. A just-released 3/
Devices
Smiths Medical is recalling (Class 1) its oral/nasal endotracheal tubes after becoming aware that certain device sizes may have a smaller diameter than represented. “If the diameter of the device is smaller than expected, it may not provide enough ventilation to the patient,” a recall notice says. “The use
Drugs
Advantage Silver Dental Arrest, Seattle, WA, is petitioning FDA to regulate silver diamine fluoride and silver fluoride agents for dentin hypersensitivity as drugs rather than medical devices and thus rescind premarket clearance of such products. The 3/17 petition says silver diamine fluoride is a liquid drug that is topically
Devices
FDA has granted Powerful Medical a breakthrough device designation for its PMcardio STEMI artificial intelligence (AI) electrocardiogram model for detecting ST-elevation myocardial infarction (STEMI) and STEMI equivalents — described by the company as a life-threatening cardiac condition requiring immediate intervention. The electrocardiogram (ECG) remains the primary tool for rapid
Devices
FDA has approved an Abbott IDE for a clinical trial to evaluate its investigational coronary intravascular lithotripsy (IVL) system and its use for treating severe calcification in coronary arteries before stenting, which the company says could offer a new solution for patients with coronary artery disease (CAD). It says CAD