Devices
An FDA 10/27-11/3/2023 inspection at Pinnacle Labs of Tennessee, doing business as Pinnacle BioLabs in Nashville, TN, identified multiple violations in the firm’s marketing and distribution of the Second Generation FIT Fecal Immunochemical Test. A just-released 4/17 Warning Letter says the company is
Devices
A 1/16-1/19/2023 FDA inspection at the Future Diagnostics Solutions facility in Gelderland, Netherlands, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of the STAT-IntraOperative Intact PTH (parathyroid hormone) Immunoassay Kits. A just-released 5/11/2023 Warning Letter says the
Devices
A 4/14-4/27/2023 FDA inspection at Spectrum Medical in Gloucestershire, UK, found Quality System Regulation violations in the firm’s manufacturing of unapproved Quantum Perfusion Systems medical devices. A just-released 9/29/2023 Warning Letter says the firm markets several devices with indications beyond what the
Devices
BioMérieux is recalling its VITEK 2 AST cards, an antimicrobial sensitivity testing kit, due to a higher concentration of ceftriaxone antibiotic in two wells. The device is used for testing how sensitive bacteria react to antibiotics. “Some of the cards have more of the antibiotic ceftriaxone in two of their
Devices
FDA has issued its long-awaited final rule that amends its regulations to make explicit that laboratory-developed tests (LDTs) are in vitro diagnostic devices (IVDs) regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). In conjunction with the final rule, the agency issued a policy
Devices
SonarMed is recalling its SonarMed Airway acoustic sensors due to a restricted inner diameter of the device resulting in difficulty passing a suction catheter through the sensor (2.5mm, 3.0mm, and 3.5mm). “Use of the affected SonarMed Sensors may cause serious adverse health consequences, including delays in treatment,
Devices
FDA has granted Roivios a breakthrough device designation for its JuxtaFlow Renal Assist Device and its use in safeguarding kidney function for patients undergoing cardiac surgeries. The device uses a “unique, gentle negative pressure technique on the kidneys’ urine-collecting system to enhance function and shield against hypoxia-induced damage
Devices
FDA has approved a Medtronic PMA for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) for treating chronic pain. “Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real-time, keeping therapy
Devices
Elekta Instrument is recalling its Disposable Biopsy Needles from one batch (837838839) because they possibly contain some microscopic stainless steel debris on the inside of the biopsy needle. “If debris on the inside of the biopsy needle comes loose, it may appear in the biopsy sample and delay or make
Devices
A 4/2 Warning Letter to Agena Bioscience saying the firm’s iPLEX HS Colon Panel is misbranded and adulterated because it is labeled for research use only (RUO) but reportedly is promoted for human clinical purposes signals a tightening of FDA’s enforcement of RUO labels. That’s the
Devices
A 12/11-12/20/2023 FDA inspection at the Cardinal Health facility in Waukegan, IL, found violations in the firm’s work as an importer/own label distributor of two types of Monoject syringes. A 4/24 Warning Letter says the syringes included in convenience kits marketed by the
Devices
InfuTronix has recalled (Class 1) its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlusion), system errors, drug product leakage, high or low flow rate, or damaged housing. According to a recall notice, the devices will not be available or supported
Devices
FDA has cleared an Expanse ICE 510(k) for the ICE Aspiration System for use in peripheral thrombectomy procedures. “The unique dual-lumen design creates the patented Surge Aspiration technology, a novel type of cyclic aspiration at the distal end of the catheter,” the company says. Expanse says the device
Devices
FDA has cleared a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum depression. The device is intended for use in patients 22 years of age and older, and as an adjunct to clinician‐managed outpatient care. It treats mild to moderate postpartum
Drugs
Three Alston Bird attorneys say there are several steps companies regulated by FDA should take to engage with the agency on its artificial intelligence/machine learning (AI/ML) regulatory activities. Writing in their firm’s FDA/Food, Drug, & Device Advisory, the three say companies should: * review and comment on
Devices
CDRH says it is launching a Home as a Healthcare Hub initiative “to help reimagine the home environment as an integral part of the healthcare system, with the goal of advancing health equity for all people in the U.S.” An announcement says the Center has contracted with an architectural
Devices
FDA has cleared a Sail Fusion 510(k) for its BowTie Sacroiliac Fusion System. The device features a novel bowtie shape as well as integrated transfixation and iliac screws to maximize rigidity, the company says. “It also utilizes a proprietary porous structure and roughened surface technology to facilitate osteointegration,” it
Devices
A 10/23-10/26/2023 FDA inspection at the Royal Philips facility in Suzhou, China, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of computed tomography and ultrasonography systems. A just-released 2/23 Warning Letter says the firm’s products are adulterated
Devices
Exactech has recalled its Equinoxe Shoulder System devices packaged in defective bags from facilities’ unused inventory. Earlier this year, FDA alerted patients and healthcare providers about the joint replacement devices and possible health risks. The devices were manufactured between 2004 and 2021, the agency said at the time. “The defective
Devices
FDA is warning against the use of over-the-counter anti-choking devices because their safety and effectiveness have not been established, and they are not approved or cleared by the agency. “Consumers should be aware that using anti-choking devices first could delay action, as consumers usually have to
Devices
FDA has cleared a Royal Philips 510(k) for its Philips Zenition 30 mobile C-arm imaging device. The company says the device features greater C-arm flexibility, control, and personalization that reduces dependency on technician support. “Advanced imaging algorithms contribute to outstanding image quality for procedure confidence, coupled with
Devices
FDA’s Medical Devices Advisory Committee’s Molecular and Clinical Genetics Panel is scheduled to review a Guardant Health PMA for its Shield blood test for colorectal cancer (CRC) screening on 5/23. The expert panel will discuss the clinical data from the company’s ECLIPSE study and the potential