FDA Archives - Medical Design Sourcing

Senseonics wins integrated CGM designation from FDA, can work with insulin pumps

The Eversense E3 system. [Image from Ascensia/Senseonics]The FDA granted integrated CGM (iCGM) designation to the Eversense continuous glucose monitoring system from Senseonics (NYSE:SENS).

With this designation, Eversense becomes the first fully implantable device in the category. Senseonics can now market the long-term CGM through the FDA’s de novo pathway. This establishes the special controls serving as a predicate device for future 510(k) submissions.

iCGM status indicates that Eversense can integrate with compatible medical devices. That includes insulin pumps as part of an automated insulin delivery system. Senseonics and Ascensia Diabetes Care, its distribution partner, plan to advance partnership discussions with pump manufacturers.

According to Senseonics, Eversense is “exceptionally well-suited” for automated insulin delivery systems.

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FDA issues warning letter to Cardinal Health for adulterated and misbranded medical devices

The FDA recently issued a warning letter to Cardinal Health (NYSE: CAH) + following an inspection at one of its facilities.

The inspection revealed unapproved device violations pertaining to the Monoject Leur-lock tip syringes and the Monoject Enteral Feeding Syringes, as well as quality system regulation violations.

Dublin, Ohio-based Cardinal Health was found to be marketing convenience kits containing certain piston syringes manufactured by Jiangsu Shenli Medical Production Co. without appropriate FDA approvals. The FDA deemed the device adulterated and misbranded under various Federal Food, Drug, and Cosmetic Act sections.

According to the warning letter, syringes with different technological characteristics in the kits posed risks to patient safety, including dosing and device leakage.

Quality system regulation violations led to a recall

Cardinal Health’s quality system regulation violations inc…

FDA clears new patient monitor from GE HealthCare

The Portrait VSM vital signs monitor. [Image courtesy of GE HealthCare]GE HealthCare (Nasdaq: GEHC) + announced today that it received FDA 510(k) clearance for its Portrait VSM vital signs monitor.

Portrait VSM provides clinicians with an accurate view of patient vital signs to support timely clinical decisions. It utilizes the SuperSTAT non-invasive blood pressure algorithm to provide precise and accurate measurement readings. Through wireless connectivity and seamless EMR integration, the monitor centers around workflow efficiency. It offers customized early warning scores (EWS) and enables care teams to focus on patient care by automating routine tasks.

The system builds on the GE HealthCare family of Portrait monitoring solutions. It can connect with the latest iteration of the Portrait Mobile wireless, wearable continuous monitoring system as well. Using a single click of a barcode scanner, Portrait VSM automatically…

Abbott wins FDA approval for dissolving drug-eluting scaffold

The Esprit everolimus-eluting scaffold. [Image from the Abbott website]Abbott (NYSE: ABT) + announced today that the FDA approved its Esprit everolimus-eluting resorbable scaffold system.

The Esprit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving.

Abbott says that before this approval, there were no stents or drug-coated balloons to treat below-the-knee chronic limb-threatening ischemia in the U.S.

The current standard of care, balloon angioplasty, relies on a small balloon delivered via a catheter. It compresses against the arterial wall, opening the blood vessel and restoring flow.

However, Abbott said blockages treated only with this method have poor short- and long-term results. Many cases result in the vessels becoming blocked again, requiring additional…

Roivios wins FDA breakthrough nod for renal assist device

The JuxtaFlow renal assist device system features a catheter (left) and pump (right). [Image from the Roivios Website]Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD).

The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during cardiac surgery. JuxtaFlow uses a unique, gentle negative pressure technique on the kidneys’ urine-collecting system. It enhances function and shield against hypoxia-induced damage under acute conditions.

JuxtaFlow combines a catheter and pump system. A trained urologist inserts the catheters in a manner similar to ureteral stent placement. Then, the catheter connects to the pump to deliver the negative pressure. Roivios designed the negative pressure to transmit through the nephrons, reducing downstream hydrostatic pressure. Controlled pressure reduction allows for effective filtration and selective …

FDA approves Medtronic’s Inceptiv closed-loop rechargeable spinal cord stimulator

The Inceptiv spinal cord stimulation system. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) system.

Inceptiv treats chronic pain and represents Medtronic’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the motions of daily life.

The medtech giant also labeled it the world’s smallest and thinnest fully implantable SCS device. Medtronic plans to begin a U.S. market launch in the coming weeks. The system already has availability in Japan and Europe, with CE mark approval coming last August.

“A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront,” said …

Demystifying deep learning: An accessible introduction to neural networks in health research and epidemiology

[Adobe Stock]

As machine learning and deep learning technologies advance thanks to advances in computation, algorithms and data availability, the possibilities of the technology continue to expand in medicine. While these AI-driven approaches have real potential, such systems demand large volumes of representative data, careful privacy and security scrutiny and thoughtful long-term strategic planning. In this Q&A, Kathryn Rough, associate director of the Center for Advanced Evidence Generation at IQVIA, discusses the impact of deep learning on healthcare delivery and recommends steps to take during the design, training, evaluation and deployment phases to increase the likelihood that these models will be safe, effective and ethical when trained on real-world health data. Rough also explores the role of epidemiologists in evaluating these technologies as part of multidisciplinary teams and provides advice for health…

Philips receives FDA warning letter over imaging systems manufactured in China

The FDA published a warning letter that it sent to Philips (NYSE: PHG) + that outlines issues around imaging technology manufacturing practices.

During an inspection of a manufacturing facility in Suzhou, China, the FDA determined that the devices are “adultered.” The inspection took place from Oct. 23, 2023, through Oct. 26, 2023. Philips received the letter outlining violations in the manufacturing of the computed tomography (CT) systems on Feb. 23, 2024.

The devices are adultered in that the methods used in, or the facilities or controls used for their manufacture, storage or installation are not in conformity with current good manufacturing practices, the FDA said.

According to the FDA, Philips Head of Quality for the plant, Xin Li, responded to the inspection’s findings on Nov. 17, 2023, and Dec. 18, 2023.

This latest regulatory setback for Philips follows the long-running saga arou…

FDA says InfuTronix infusion pump recall includes 1 death

The Nimbus infusion system. [Image from InfuTronix]The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death.

Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues with the Nimbus infusion pump systems was related to one user death.

InfuTronix said it found 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. The company also reports 3,698 complaints as a result of the issues and six serious injuries. InfuTronix won’t offer or support the devices after June 20, 2024.

Using affected pumps could cause infection from microbial contamination after loss of the sterile barrier (leakage). It could also lead to interruptions or delays …

FDA wants to advance health equity through home-based care

The FDA has announced an initiative to reimagine the home environment as an integral part of the healthcare system and promote health equity for all Americans.

The new initiative, called “Home as a Health Care Hub,” seeks to address the longstanding disparities in healthcare access and outcomes using home-based care. FDA’s Center for Devices and Radiological Health (CDRH) said the move comes amidst a shifting clinical care landscape brought on by the COVID-19 pandemic.

In a joint statement, FDA CDRH Director Jeff Shuren and Deputy Director for Transformation Michelle Tarver said the healthcare system faces persistent challenges. These include shortages of healthcare professionals, rising costs and disparities in access that can affect more marginalized communities.

Related: Biden signs executive order for women’s health research and innovation

When devices don’t operate together, the FDA says pat…

Blue Arbor wins FDA breakthrough nod for neuromuscular interface

A screenshot from a Blue Arbor video demonstrating the capabilities of the Restore system.

Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system.

The FDA also accepted the system into its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices.

Grass Lake, Michigan-based Blue Arbor designed Restore to integrate into the peripheral nervous system with available robotic prosthetics. It aims to restore naturalistic hand and arm function in patients with upper limb loss. The platform could enable patients to move upper limb prosthetic devices with improved dexterity, speed and reliability.

Features of the Blue Arbor Restore system

Restore features implantable intramuscular electrodes, a sensing uni…

FDA clears Epitel remote monitoring tech, AI detection platform

A rendering of the Remi system. [Image from the Epitel website]Epitel announced today that it received FDA 510(k) clearance for two new patient-focused brain health offerings.

The FDA cleared the Remi remote EEG monitoring system for ambulatory use and the Remi Vigilenz AI for event detection. Remi for ambulatory use allows for EEG recording in outpatient and home environments for an extended duration. Vigilenz AI analyzes and marks Remi EEG records for potential electrographic seizures to assist with ease and accuracy of interpretation.

Remi ambulatory allows for an extended EEG in the comfort of the home while going about daily activities. It leverages the same sensors used in the Remi platform for healthcare facility use and adds a mobile computing platform. This allows patients and caregivers to mark when they’ve experienced an event or suspected event.

Epitel designed Remi Vigilenz AI for detection to levarage state-of-the-art proprietary machine…