Devices
The Justice Department says C.R. Bard and three affiliates have agreed to pay $17 million to resolve a whistleblower’s allegations that they violated the False Claims Act and several state false claims acts by providing free samples and discounts to encourage urology practice groups to use Bard’s
Devices
FDA has granted Lumitron Technologies a breakthrough device designation for its HyperVIEW X-Ray system, which uses the “K-Edge subtraction technique” to enable contrast-enhanced imaging for diagnosing breast cancer. “This technology utilizes Lumitron’s proprietary distributed charge laser-Compton technology to provide imaging that is both 100 times
Devices
Medtronic Neurosurgery is recalling (Class 1 device correction) certain Becker and Exacta External Drainage and Monitoring Systems due to a risk for cracks and leaks in device stopcocks. “The use of affected product may cause serious adverse health consequences, including leaks of cerebrospinal fluid, infections, and death,” a recall notice
Devices
FDA has cleared an EssilorLuxottica 510(k) for its over-the-counter Nuance Audio Glasses. EssilorLuxottica says the device provides an open-ear hearing solution integrated into a pair of smart glasses. “After decades of adoption barriers ranging from comfort to visibility, consumers will finally be able to see clearly
Devices
FDA has cleared a Gyder Surgical 510(k) for the Gyder Hip System and its use in positioning the acetabular cup during anterior hip arthroplasty. The company says the device is designed to improve acetabular cup placement accuracy to reduce post-surgery complications. Unlike traditional hip navigation approaches, the Gyder
Devices
Nova Biomedical is recalling (Class 1 device correction) its StatStrip Glucose and Glucose/Ketone Hospital Meters due to the potential risk that a software error may cause incorrect glucose or ketone patient test results to be transmitted to hospital medical record systems. “The issue occurs when an operator visits the
Devices
An FDA safety communication says that cybersecurity vulnerabilities in certain Contec and Epsimed (relabeled Contec) patient monitors may put patients at risk after being connected to the Internet. The communication says these three vulnerabilities have been identified: * the patient monitor may be remotely controlled by an unauthorized user or not
Devices
FDA has granted OrthoPreserve a breakthrough device designation for its Defender meniscus replacement knee implant. The agency has also accepted the device for enrollment in CDRH’s Total Product Life Cycle Advisory Program (TAP). The breakthrough designation covers the implant’s use for treating patients who continue to experience knee
Devices
FDA has granted Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio assay, a blood test to help identify patients with amyloid pathology associated with Alzheimer’s disease. The company says the assay measures the ratio of phosphorylated tau protein (p-
Devices
FDA has cleared an AI Optics 510(k) for its Sentinel Camera, a handheld retinal imaging device for capturing images of the human eye. The AI Optics says the camera is intended for use at point-of-care facilities (general/primary healthcare providers) to eliminate the need for visiting an
Drugs
TerSera Therapeutics is petitioning FDA to require that ANDAs citing the company’s Prialt (ziconotide) as the reference-listed drug/device combination to meet compatibility testing requirements to support product labeling for use with the Medtronic SynchroMed II and SynchroMed III infusion system. The company’s petition says Prialt is
Devices
FDA has cleared an Imperative Care 510(k) for its Zoom System, a stroke thrombectomy system with .088-inch catheters indicated for both access and aspiration when used with a Zoom Catheter. The clearance expands Imperative Care’s current offering of .035” to .071” aspiration catheters, the company says. The
Devices
FDA has cleared a ClearPoint Neuro 510(k) for its ClearPoint Navigation Software Version 3.0. The new platform introduces an intraoperative computed tomography (CT)-guided workflow to its existing MRI-guided stereotactic procedures offering, according to the company. “With compatibility for intraoperative CT and Conebeam CT imaging, this enhancement
FDA Policy/General
Three Ropes & Gray attorneys write in their 2024 FDA Enforcement Review that while the agency’s focus may shift with the new administration, “industry should continue to invest in strong regulatory compliance and quality programs that encourage the reporting and thorough investigation of potential problems and facilitate prompt corrective
Devices
Commenting on an FDA 11/20-11/21/2024 Digital Health Committee meeting, GE HealthCare says generative artificial intelligence (GenAI) and foundation models (FM) “have immense potential to revolutionize clinical care and medical technology, including medical devices.” In its letter, the company says it is “essential to implement these technologies
Devices
FDA has cleared an Inflammatix 510(k) for its TriVerity Test System, which it describes as a first-in-class molecular test for patients with suspected acute infection or sepsis. “Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-
Devices
In 2024, CDRH granted marketing authorization to 120 novel devices, which was four less than the previous year’s record-setting 124 devices, according to the Center’s just-released 2024 annual report. The Center also continues to see increasing interest from developers to bring their novel technologies to market
Devices
Medline Industries has recalled (Class 1) its Medline Fluid Delivery Set with Drip Chamber because the devices were incorrectly assembled with a white macro drip chamber instead of the required gray micro drip chamber. “The macro drip chamber delivers three times more fluid per drop than the micro drip chamber,
Devices
FDA says it is aware that Fresenius Kabi USA has contacted affected healthcare providers recommending updates to certain software versions of the Ivenix Infusion System. An agency Early Alert says the recommended updates are related to a potentially high-risk device issue. The notice lists anomalies reported by the company
Devices
A 6/25-7/11/2024 FDA inspection at Xoran Technologies in Ann Arbor, MI, identified Quality System Regulation violations in the firm’s manufacturing of computed tomography systems and supporting software. A just-released 12/9/2024 Warning Letter says the specific violations were: * failure to establish and maintain
Devices
A 4/22-7/17/2024 FDA inspection at Phillips Precision in Elmwood Park, NJ, found Quality System Regulation violations in the firm’s contract manufacturing of orthopedic implants and instruments. A just-released 12/9/2024 Warning Letter says specific violations were: * failure to ensure that when the results
Devices
AdvaMed recommends that FDA revise the title of CDRH’s Device Trial Participation Snapshots to reflect that the program intends to provide key information about clinical trials that support the agency’s approval of new medical devices. The association’s comment letter also makes these recommendations: * allow sponsors to review