Devices
A 2/23-2/24 FDA inspection at Nihon Kohden Digital Health Solutions in Irvine, CA, determined that the firm manufactures the Next Generation NetKonnect software device, described as a patient physiological monitor device with an arrhythmia detector and alarm. A just-released 6/12 Warning Letter says the device
Drugs
FDA acting commissioner Kyle Diamantas is commenting on the traditional agency public health pillars that are being rearticulated “in a way that reflects the scientific, technological, and geopolitical reality shaping this new era of innovation as well as the future of public health.” Writing in an FDA Voices online column,
Drugs
Rep. Frank Pallone (D-NJ), the ranking member on the House Energy and Commerce Committee, has asked the Government Accountability Office (GAO) to analyze the impact of the FDA reduction-in-force (RIF) efforts through the so-called Department of Government Efficiency (DOGE) or other means on the agency’s
Devices
A 1/5-1/12 FDA inspection at ZIIP, Inc. in Pleasant Hill, CA, determined that the firm manufactures the ZIIP HALO device and the HALO 2.0, ZIIP DOT, and ZIIP Gels. A just-released 5/22 Warning Letter says all of the devices other than the original ZIIP
Drugs
Former FDAer David Gortler, who is now a Heritage Foundation senior research fellow, sees a correlation between the increasing number of drug and medical device recalls in the last few years and a change in the way the agency approaches facility inspections. Writing in an online Independent Institute news article,
Devices
A 10/30-11/19/2025 FDA inspection at the BlephEx facility in Brentwood, TN, determined that the firm manufactures the BlephEx Powered Eyelid Cleaning Sponge, the OptiVue Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVue Ophthalmic Forceps. A just-released 6/3 12-page Warning Letter lists unapproved device
Devices
FDA has approved Johnson & Johnson’s Dual Energy Thermocool Smarttouch SF Platform, a catheter ablation system that combines pulsed field (PF) and radiofrequency (RF) energy delivery in a single device for treating cardiac arrhythmias. The platform allows electrophysiologists to switch between pulsed field and radiofrequency ablation using the same
Drugs
With FDA using its artificial intelligence (AI) tool ELSA during inspections, regulated companies can better prepare for inspections by using their own AI tool. That’s the view of former FDAer David Elder. Writing in a Med Device Online guest column, Elder says using ELSA enables an FDA investigator to
Devices
FDA has released the draft MDUFA Performance Goals and Procedures agreed to by CDRH and CBER under the MDUFA renewal of 2027. “Both FDA and the industry are committed to the spirit and letter of the goals described in this letter,” the document says. The specific goals and procedures are
Devices
FDA says the Abiomed 5/18 recall of certain Impella CP Sets with SmartAssist is Class 1. An agency notice says Abiomed reported that specific distributed units of Impella CP with SmartAssist do not meet design specifications. “This out-of-specification may result in low purge pressure events from the
Devices
FDA says the Insulet 5/26 recall of certain Omnipod Pods is Class 1. An agency notice says Insulet identified that some pods from specific lots may have a small tear in the cannula just above the skin, between the Pod and the point where the cannula enters the body.
Devices
A 12/1-10/10/2025 FDA inspection at 3B Medical, doing business as Reach Health, in Dublin, OH, established that BMC Medical in Beijing, China, is the specification developer and 510(k) owner of various ventilator devices that are imported into the U.S. A just-released 5/20
Devices
A 12/1-12/10/2025 FDA inspection at 3B Medical, doing business as Reach Health in Dublin, OH, found multiple violations in the firm’s manufacturing of iCodeConnect, a cloud-based software device used with continuous positive airway pressure and auto-adjusting positive airway pressure ventilator devices. A just-
Devices
A 11/9-12/3/2025 FDA inspection at AseptiKits in North Salt Lake, UT, found that the company manufactures and markets several PALA Your Tears models. A just-released 6/4 Warning Letter says the firm’s PALA Your Tears models are adulterated because the firm does not have
Devices
FDA says that based on its data analyses, it has determined that CCIC Huatongwei International Inspection (Suzhou) Co., Ltd., in Suzhou, Jiangsu Province, China, has, in several instances, copied the results of another study or created falsified or otherwise invalid medical device data that were submitted to the agency. “Until
Devices
Sen. Tom Cotton (R-AR) has introduced legislation that would require FDA to review and potentially recall Chinese-manufactured networked medical devices deemed to pose cybersecurity risks to American patients. The proposed legislation, titled the Countering Chinese Cyberthreats for Patients (Countering CCP) Act, would direct FDA and the Cybersecurity and
Devices
Harmed Americans for Reform in Medical Device Safety, which is led by cardiac surgeon Nooman Noorchashm, known to FDA for his opposition to power morcellation and for raising issues about surgical mesh, is petitioning the agency to require Vena Medical to obtain an IDE for its MicroAngioscope. The 6/22
Devices
FDA has formally closed an enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about whether the company's Blood Pressure Insights feature should be regulated as a medical device. In a recently issued closeout letter, FDA informed the wearable technology company that it had
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pump systems manufactured by Abiomed and its manufacturing partner Oscor. According to the agency, certain 14 French and 23 French introducer sheaths may develop unexpected leakage from
Devices
FDA has provided additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate development of medical devices intended to reduce avoidable hospital readmissions by supporting patients in home settings following discharge. The challenge, formally known as READI-Home: Reducing Readmissions through Device Innovation for the
Devices
FDA’s release of information from the first 100 medical device inspections conducted under the new Quality Management System Regulation (QMSR) provides a real service for medical device manufacturers that treat QMSR as the inspection model it actually is. That’s the view of independent expert Marcelo Trevino writing in
Drugs
North Dakota State University economics professor Raymond March says there is a clear reason why FDA struggles to provide effective risk management guidance and seems to flounder when asked to manage risk for others: it can’t. Writing for the Independent Institute in an online post, March argues that “risk