Biologics
In a Hyman, Phelps & McNamara FDA Law Blog post, principal regulatory device and biologics expert Richard Lewis, who was an FDA reviewer and compliance officer during the 2018-2019 five-week government shutdown, describes what such a funding gap means for the agency and its regulated industries. The post
Drugs
The Sedgwick “State of the Nation 2025” report shows that medical device recalls increased 8.6% in 2024, from 975 recalls in 2023 to 1,059 in 2024. The report finds that drug recalls dropped 31%, from 571 in 2023 to 356 in 2024. Device failure was the leading recall
Devices
Becton Dickinson has recalled one lot of ChloraPrep clear 1 mL applicators due to fungal contamination observed under certain environmental conditions allowing Aspergillus penicillioides to grow. Any fungal presence within the device packaging can contaminate the applicator’s surface or gloved hands of a healthcare professional and then consequently the
Devices
Harmed Americans for Reform in Medical Device Safety (HARMS), an organization with no Internet presence and no information available in a Google search, is petitioning FDA to evaluate new studies and publish guidance or public information on robotic mastectomy to treat breast cancer. The petition, which was signed by cardiothoracic
FDA Policy/General
In a guest Med Device Online column, ERA Sciences executive director Eva Kelly lists and analyzes FDA’s top five citation issues for data quality in 2024. The issues were: * governance and standard operating procedure weaknesses; * validation deficiencies; * system inventory gaps; * missing records or data missing key ALCOA++ (attributable, legible,
Devices
Abiomed is recalling (Class 1) Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps to update their use instructions due to a risk that the tip of guidewires or other medical devices may come into contact with the pump during insertion, adjustment, or removal. The inadvertent contact
Devices
The Department of Justice has sent a civil investigative demand (CID) to Inspire Medical over allegations of false claims submitted to government healthcare programs for its sleep apnea implant. CEO Tim Herbert reportedly revealed the CID during a 2/10 earnings call but gave few details. The CID reportedly requests
Devices
Olympus has recalled (Class 1) its bronchoscope single-use guide sheath kits due to potential for the radiopaque tip of the guide sheath component to separate and fall off into the patient. According to a recall notice, the cause of the component separation is under investigation by the company. Olympus
Devices
Max Mobility has recalled its Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial for wheelchair use due to a faulty circuit board in its speed control remote that could lead to loss of control of the device. If a loss of control occurs, this could result in minor and major
Devices
FDA has granted Guerbet a Breakthrough Device Designation for LipioJoint, a transient liquid embolic agent designed to alleviate pain in patients with knee osteoarthritis. The company says the device is being developed for Genicular Artery Embolization (GAE), a minimally invasive procedure performed by interventional radiologists. The product is intended to
Devices
Former FDA commissioner Scott Gottlieb, now an American Enterprise Institute senior fellow, cautions that a high-value application of artificial intelligence (AI) and artificial general intelligence (AGI) in medicine hinges on their seamless integration into an electronic medical record (EMR), accessing and synthesizing diverse data. He says current FDA policies
Devices
Sentec/Percussionaire is recalling (Class 1) its Phasitron breathing circuit kits after receiving a complaint that the venturi component stopped oscillating during use, which caused a patient’s oxygen levels to fall. “The risk of failure is especially high for pediatric patients due to the low pressures that are associated
Devices
FDA has cleared an Ibex Medical Analytics 510(k) for the Ibex Prostate Detect, an in vitro diagnostic that uses artificial intelligence to generate heatmaps to identify small and rare missed prostatic cancers. The device was designed to act as a “safety net that assists pathologists in ensuring patients receive
Devices
FDA has cleared a RapidAI 510(k) for its Lumina 3D, an automated 3D imaging reconstruction device designed to replace manual workflows with an artificial intelligence-powered approach. “Obtaining high-quality 3D images within minutes of a CTA [computed tomography angiography] scan marks a significant advancement and milestone in neuroradiology,
Devices
An FDA notice is alerting healthcare professionals and patients about medical device reports (MDRs) detailing “breast implant illness” with a variety of systemic symptoms that have been reported following reconstruction or augmentation with breast implants. “These symptoms include, but are not limited to, fatigue, problems with memory or concentration (brain
Devices
FDA has issued an alert about Bard Peripheral Vascular’s Rotarex Atherectomy Systems because the helix portion of the device rotates at a high rate of speed and may be at risk of fracture or breakage when exposed to certain stress, wear, high temperatures, friction, or localized pressure. “Use of
Drugs
A Cooley Alert says a recent 4th Circuit Court of Appeals decision in a Medicare fraud case may embolden the government to reject the “practice of medicine” defense whenever a healthcare practitioner uses an approved or cleared medical device for off-label uses, under the theory that any device that
Devices
FDA says the 12/31/2024 Medline Industries recall of integrated arterial catheters is Class 1. An agency notice says the recall was due to a manufacturing issue that caused excess material to be present on the catheter hub. “If a catheter with excess material at the hub is used,
Devices
FDA has issued a safety alert on certain diabetes devices (e.g., continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems) that rely on a smartphone to deliver critical safety alerts. Smartphone users with diabetes-related apps on their phones can configure alert settings to customize which alerts
Devices
FDA has granted Acrivon Therapeutics a breakthrough device designation for the ACR-368 OncoSignature assay, which the company describes as a multiplex immunofluorescence assay for identifying endometrial cancer patients who may benefit from ACR-368 treatment. The device is being developed to prospectively predict tumor sensitivity to ACR-368, described
Devices
Baxter Healthcare Corporation is recalling (Class 1 device correction) its Life2000 Ventilator System due to a nonconforming battery charger, which triggers a battery alarm and makes the ventilator inoperable. “This is a result of a failed crimping operation during manufacturing that caused the crimp to puncture the insulation of the
Devices
FDA says the Trokamed 11/26/2024 recall that updated instructions for its Mini PCNL sheath is Class 1. An agency notice says Trokamed recommended these actions: * not to use the Mini PCNL sheath as a suction and irrigation device; * temporarily remove the nephroscope from the shaft to clear it