Devices
Based on the discussion at an FDA Digital Health Advisory Committee public meeting on “Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices,” five Orrick attorneys say that manufacturers developing large language model-based prescription therapies for major depressive disorder “should anticipate a risk-based, lifecycle regulatory approach.” In an
Devices
FDA has approved Promega’s OncoMate MSI Dx Analysis System as a companion diagnostic for identifying patients with microsatellite stable endometrial carcinoma who may benefit from treatment with Merck’s Keytruda (pembrolizumab) in combination with Eisai’s Lenvima (lenvatinib). The polymerase chain reaction-based assay is designed to determine microsatellite
Devices
Three Alston & Bird attorneys say that complying with FDA’s forthcoming Quality Management System Regulation (QMSR) is not just a regulatory obligation but a critical business strategy. Writing in a detailed Drug & Device Advisory, the attorneys discuss FDA’s 10/27 draft guidance describing the Quality Management System
Devices
FDA has given investigational device exemption (IDE) approval for an Aqua Medical pilot clinical trial of its Proximal Intestinal Mucosal Ablation (PIMA) procedure using the company’s proprietary radiofrequency vapor ablation (RFVA) system. A company statement says FDA has already granted the system a breakthrough device designation to treat adults
Devices
FDA has issued an updated safety communication confirming long-term post-approval data showing that the Hintermann Series H3 Total Ankle Replacement system continues to demonstrate a higher-than-expected risk of device failure, with revision rates increasing significantly over 10 years of follow-up. According to a final post-
Devices
FDA has cleared a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer, the HLC-723 GR01, for rapid and precise HbA1c (blood sugar) testing. The new system can deliver results in as little as 50 seconds, supporting both diabetes diagnosis and long-term glucose monitoring, according to
Devices
A 6/30-7/3 FDA inspection at Qinjiang Kingphar Medical Material Co. in Qinjiang, China, identified two Quality System Regulation violations in the firm’s manufacturing of surgical masks, wound dressings, sterilization wraps, and surgical drapes. A 10/3 Warning Letter says the specific violations were: * failure to establish
Devices
A 6/9-6/12 FDA inspection at Centec Medical Systems in Qinhuangdao, China, found Quality System Regulation and other violations in its production of several medical devices. A 10/2 Warning Letter says the specific violations were: * failure to adequately establish procedures for corrective and preventive action; * failure to
Devices
FDA inspections at three Royal Philips medical device manufacturing facilities — Bothwell, WA, Reedsville, PA, and Eindhoven, Netherlands — identified Quality System Regulation and other violations in the firm’s manufacturing of several medical devices. A just-released 9/9 Warning Letter says the specific violations were: * failure to establish and maintain
Devices
Warning Letters sent recently by FDA to two medical device companies instructed the firms to respond within 30 days, rather than the typical 15 days. Three Hyman, Phelps & McNamara attorneys write in their firm’s FDA Law Blog that their review of some 200 Warning Letters issued by CDRH
Devices
FDA has published a draft guidance, Menstrual Products—Performance Testing and Labeling Recommendations, with the agency’s recommendations for performance testing and labeling of such products, and also information for inclusion in 510 (k) submissions, when necessary, for certain menstrual products. The document says its recommendations apply to tampons, pads,
Devices
FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System (QMS) information to include in premarket submissions. The agency says the document is intended to help companies prepare and maintain a QMS and provide sufficient information for FDA to assess compliance with
Devices
FDA has cleared a YorLabs 510(k) for its new intracardiac imaging system that the company says could reshape workflows in catheterization labs by eliminating the need for costly capital equipment. The platform, which YorLabs describes as the first “zero-CapEx” intracardiac echocardiography (ICE) solution, delivers real-time, high-resolution
Devices
A 7/10-7/11 FDA inspection at Dongguan Rainbow Tech Electronic & Plastic Products Co., Ltd., in Guangdong Sheng, China, found Quality System Regulation violations in the firm’s manufacturing of Class 2 manual emergency ventilators. A 10/7 Warning Letter says the specific violations were: * failure to establish
Devices
A 4/7-4/9 FDA inspection at Levo AG in Wohlen, Switzerland, found multiple violations in the firm’s manufacturing of several models of Class 2 stand-up wheelchairs. A just-released 7/18 Warning Letter says the specific violations were: * failure to establish and maintain a quality system
Devices
In a recent submission to the Trump administration, the Advanced Medical Technology Association (AdvaMed) outlined a series of recommendations aimed at strengthening U.S. leadership in medical technology and safeguarding national security amid reliance on imported devices, personal protective equipment and medical consumables. AdvaMed proposed the creation of a new
Drugs
FDA is laying the groundwork for a future where real-world evidence (RWE) and artificial intelligence (AI) work together to deliver better outcomes for patients and more efficient pathways for innovation. That’s the takeaway posted in a blog by Adrienne Lenz, the principal medical device regulation expert at Hyman,
Devices
FDA has issued a new safety communication warning about reports of serious complications associated with certain uses of radiofrequency (RF) microneedling devices, commonly used in aesthetic skin treatments. The devices deliver radiofrequency energy through tiny needles to heat tissue under the skin, a process marketed for skin tightening, wrinkle reduction,
Devices
FDA has cleared Roche’s Elecsys pTau 181 test, which the company says is the only blood-based biomarker test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary care setting. Roche says the Elecsys pTau 181 test
Devices
FDA says it is aware that LifeVac, LLC, in Nesconset, NY, is illegally marketing its LifeVac Rescue Suction device since the device does not have agency marketing authorization. A just-released 9/18 Warning Letter says the airway clearance device is used for resuscitating a victim with an airway obstruction
Devices
FDA has approved SQ Innovation’s drug-device combination Lasix ONYU (furosemide injection) for treating edema (due to fluid overload) in adult patients with chronic heart failure. The product was developed to enable subcutaneous infusion of furosemide outside the healthcare setting for selected patients, according to the company. Lasix ONYU
Devices
FDA has cleared a Methinks AI 510(k) for its Methinks CTA Stroke, an artificial intelligence–based software tool that detects suspected large vessel occlusions (LVOs) using CT angiography scans. The software demonstrated 98.2% sensitivity and 91.6% specificity, including detection of distal occlusions up to the MCA-M2