Blog Articles
Medtronic’s StealthStation S8 Software Recall Classified as Class I by FDA
Medtronic has initiated a recall of certain versions of its StealthStation S8 application, following customer feedback about a software glitch. The recall affects versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 of the software. This glitch causes numbers or letters to be omitted from the displayed text, impacting critical measurements such as the “distance to target” or “tip stop point” during neurosurgical navigation. The U.S.
Optum Health Care Solutions is recalling the Nimbus II Plus Ambulatory Infusion Pump System.
Optum Health Care Solutions is recalling the Nimbus II Plus Ambulatory Infusion Pump System due to multiple potential failure modes, including battery issues, occlusions, system errors, and leakage. This recall, prompted by InfuTronix’s February 2024 recall, is classified as a Class I recall by the FDA, indicating a risk of serious injury or death. The affected devices, distributed between August 2020 and April 2024, will be unavailable after June 20, 2024.
Addressing the Crisis of Health Literacy and Trust in American Healthcare
At Fortune’s Brainstorm Health conference in Dana Point, California, Dr. Michelle Gourdine, senior vice president of CVS Health and chief medical officer of CVS Caremark, highlighted a significant issue facing the U.S. healthcare system: the lack of health literacy among Americans.
The U.S. Food and Drug Administration (FDA) has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris.
FDA Approves First Interchangeable Biosimilar for Rare Diseases May 28, 2024 The U.S. Food and Drug Administration (FDA) has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab). This approval is significant for treating rare diseases, particularly paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Key Points: Treatment Indications: PNH: Reduces hemolysis (breakdown of red blood cells). aHUS: Inhibits complement-mediated thrombotic microangiopathy.
FDA issues warning against using Cue Health’s COVID-19 tests due to a heightened risk of false positive results.
The FDA has issued a warning against using Cue Health’s over-the-counter COVID-19 tests due to a heightened risk of false positive results. The agency advises both consumers and healthcare providers to discontinue using these tests. This recommendation follows unauthorized modifications made by Cue Health to their test formulas and device firmware without FDA approval.
First Cases of HIV Transmitted Through Cosmetic Needles Identified: CDC
In a groundbreaking report, the Centers for Disease Control and Prevention (CDC) confirmed the first known cases of HIV transmission through cosmetic needles. This alarming discovery emerged after three women contracted HIV following platelet-rich plasma (PRP) microneedling facials, commonly known as vampire facials, at an unlicensed spa in New Mexico. The implicated establishment, VIP Spa, has since been closed.
Tandem Diabetes Care Recalls t:connect Mobile App Due to Software Issue Leading to Battery Drain in Insulin Pumps
Overview: Tandem Diabetes Care, Inc. has issued a recall for Version 2.7 of the Apple iOS t:connect mobile app, used with the t:slim X2 insulin pump featuring Control-IQ technology. This recall, classified as a Class I by the FDA—the most serious type—addresses a software problem causing significant battery depletion in the insulin pumps, potentially leading to pump shutdown and serious health risks.
The U.S. Food and Drug Administration (FDA) has issued its final guidance on the remanufacturing of medical devices.
This guidance aims to clarify the distinction between servicing and remanufacturing, emphasizing that remanufacturers, including those who did not originally manufacture the device, are subject to the same regulatory requirements and inspections as original equipment manufacturers (OEMs). Key points include: Definition Clarity: Servicing involves repair and maintenance to restore a device to its original use, whereas remanufacturing significantly alters a device’s performance or safety specifications beyond its original intended use.
Philips Faces Another Major Ventilator Recall
Philips is dealing with a new Class I recall of its Trilogy Evo ventilators, marking the FDA’s most serious level of recall. Initiated voluntarily by Philips in March, the recall involves nearly 91,000 devices distributed in the U.S. between March 2019 and February 2024. The issue stems from a software malfunction that can cause sudden loss of ventilation despite sufficient battery power.
The FDA’s Medical Device Development Tools (MDDT) program is fostering innovation in the medical device industry
By qualifying tools like biomarker tests, outcome measures, and digital health technologies, the FDA aims to enhance predictability and efficiency in regulatory reviews. The voluntary program provides a framework for assessing tools’ suitability and utility, reducing the need for repeated evaluations for each device submission. Previously, tools were evaluated on a case-by-case basis, but the MDDT program offers a standardized process, benefiting both device sponsors and regulators.