FDA Archives - Page 10 of 103 - Medical Design Sourcing

Device strategies to prevent healthcare-associated infections

[Image courtesy of the National Institute of Allergy and Infectious Diseases]

Device design, sterilization before use and proper cleaning of reusable equipment can prevent infections and save lives.

By Ted Eveleth, AvantGuard

Nosocomial infections, also commonly known as healthcare-associated infections (HAIs), are a multibillion-dollar problem and a leading cause of morbidity and mortality around the world. On any given day, about 1 in 31 hospital patients has at least one HAI, according to the Centers for Disease Control and Prevention.

A significant cause for many of these HAIs are medical devices that touch or are implanted in the body, such as surgical implants, catheters and endoscopy devices.

For example, 75% of urinary tract infections in healthcare settings are associated with urinary catheters. Central line-associated bloodstream infection (CLABSI), another category of HAIs associate…

InBrain Neuroelectronics wins FDA breakthrough nod for intelligent network modulation system

The graphene-based, high-resolution cortical brain interface. [Image courtesy of InBrain Neuroelectronics]InBrain Neuroelectronics announced today that it received FDA breakthrough device designation for its intelligent network modulation system.

The breakthrough nod covers the graphene-neural platform as an adjunctive therapy for treating Parkinson’s disease.

InBrain’s system harnesses the power of graphene, a two-dimensional material made of a lattice of carbon atoms. The thin material — stronger than steel, the company says — utilizes a combination of electrical and mechanical properties.

According to InBrain, the neural platform enables ultra-high signal resolution, using machine learning software to decode therapy-specific biomarkers. It delivers highly focused, adaptive neuroelectronic therapy that re-balances pathological neural networks.

The semiconductor-derived brain-computer interface (BCI) technology could decode and modulate …

FDA grants IDE to Orchestra BioMed for cardiac neuromod trial in pacemaker patients

Rendering of the BackBeat therapy from an Orchestra BioMed YouTube demonstration.

Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its BACKBEAT trial.

BACKBEAT (bradycardia pacemaker with atrioventricular interval modulation for blood pressure treatment) evaluates the safety and efficacy of atrioventricular interval modulation (AVIM) therapy. Also known as BackBeat CNT, it treats hypertensive patients indicated for a dual-chamber cardiac pacemaker.

New Hope, Pennsylvania-based Orchestra BioMed has the backing of medtech giant Medtronic in this effort. The companies announced a strategic collaboration to develop and commercialize AVIM therapy for pacemaker patients in July 2022. Under the collaboration, Medtronic offers development, clinical and regulatory support for the BACKBEAT trial.

Medtronic also contributed to a $110 million Series D at Orchestra BioMed, which soon went public through a …

CereVasc wins FDA IDE to expand eShunt trial

CereVasc announced today that the FDA approved an investigational device exemption (IDE) supplement for a study of its eShunt system.

The FDA permitted the expansion of the study for patients with normal pressure hydrocephalus (NPH) to additional participants and sites. The company initiated the pilot study of its eShunt system under IDE in August 2022.

Boston-based CereVasc said the supplement also allows for the use of the next-generation eShunt system in the NPH study. The company designed the system to simplify the device preparation process and enhance overall ease of use while maintaining performance.

eShunt offers a minimally invasive treatment with the potential to result in benefits over the current gold-standard treatment. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components.

“The early results we have seen in our pilot study of the eShunt System in treating patients with iNPH have bee…

FDA authorizes Attune Medical’s ensoETM for use in RF ablation procedures

A rendering of EnsoETM in use. [Image courtesy of Attune Medical]Attune Medical announced today that it received FDA de novo marketing authorization for its ensoETM device in ablation procedures.

Chicago-based Attune designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures. ensoETM received FDA investigational device exemption (IDE) for this indication just over one year ago.

The FDA nod came on the back of pre-clinical studies, computer models, three randomized controlled studies and data from tens of thousands of patients treated in real-world settings. Studies demonstrated up to an 83% reduction in esophageal injuries. Additionally, ensoETM reduced the risk of atrioesophageal fistula (AEF), a complication of ablation procedures.

De Novo authorization expands ensoETM’s indications for use to reduce the likelihood of esophageal injury in these …

Abbott recalls neurostimulation implants for Bluetooth bricking flaw

Abbott’s Proclaim XR 5 IPG Model 3660 and the Patient Controller app. (Image from Abbott)

Abbott (NYSE: ABT) + has recalled more than 155,000 implantable pulse generators (IPGs) due to a Bluetooth connectivity flaw that has left some devices unusable.

The Class I recall — the FDA’s most serious level — covers Proclaim and Infinity IPGs used for three kinds of neurostimulation:

Spinal cord stimulation: Proclaim XR 5 IPG Model 3660 (previously known as the Proclaim 5 Elite IPG Model 3660), Proclaim XR 7 IPG Model 3662 (previously known as the Proclaim 7 Elite IPG Model 3662), Proclaim Plus 5 IPG Model 3670, and Proclaim Plus 7 IPG Model 3672 Dorsal root ganglion stimulation: Proclaim DRG IPG Model 3664 Deep brain stimulation: Infinity 5 IPG Model 6660 and Infinity 7 IPG Model 6662

These devices were distributed in the U.S. between Nov. 21, 2015 and to June 29, 2023. The FDA said 186 incidents and 73 injuri…

Procept BioRobotics wins FDA IDE for Aquablation prostate cancer therapy

The robotic technology used for the Aquablation procedure. [Image from the Procept BioRobotics website]Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA investigational device exemption (IDE) for its Aquablation therapy.

The IDE allows Procept to initiate a single-arm feasibility study for the Aquablation prostate cancer therapy in the U.S. Data generated from the study could support future research and regulatory applications in the U.S. The company plans to enroll patients with localized prostate cancer across three cancer centers in the country.

Redwood City, California-based Procept says the study takes place at Keck Medical Center (California), Perlmutter Cancer Center at NYU Langone Health and Mount Sinai Tisch Cancer Center (both New York).

About the Procept BioRobotics Aquablation therapy

Dr. Inderbir Gill, founding executive director for USC Urology as part of Keck, said Aquablation therapy provides efficacy and safety. Gill sa…

FDA approves LimFlow chronic limb-threatening ischemia treatment

The LimFlow System turns a vein into an artery to deliver blood flow down to an ischemic foot. This aims to prevent amputation, relieve pain and promote wound healing in patients with CLTI. [Image courtesy of LimFlow]LimFlow announced today that the FDA approved its LimFlow System for treating chronic limb-threatening ischemia (CLTI).

Approval enables the treatment to help those with CLTI with no other suitable endovascular or surgical treatment options available. These patients can face major amputation as a result of their condition.

France-based LimFlow designed its TADV (transcatheter arterialization of deep veins) system to reestablish blood flow in deep veins. It treats “no-option” CLTI patients who exhausted all other treatment methods. The therapy aims to prevent amputation and the associated complications, mortality and deterioration of quality of life.

This minimally invasive system bypasses blocked arteries in the leg and delivers oxygenated bloo…

Paragon 28 wins FDA IDE approval for study of talar replacement system

The Smart Total Talus system. [Image courtesy of Paragon 28]Paragon 28 (NYSE:FNA) announced today that it received FDA investigational device exemption (IDE) for its Smart Total Talus system.

IDE enables Paragon 28 to conduct a feasibility study for configurations of Smart Total Talus. It evaluates the system in conjunction with the APEX 3D system. The company expects its study of the talar replacement and ankle replacement systems to begin in early 2024.

Englewood, Colorado-based Paragon 28 says the milestone helps to advance its Smart 28 strategy. Through this strategy, the company aims to provide meaningful options to surgeon customers and significantly improve patient outcomes. Garnering IDE adds to the company’s existing patient-specific total talus offering, the company said. It expands the use of the technology into prospective total ankle replacement candidates.

Paragon 28 acquired Additive Orthopedics in June 2021, adding the company’s …

FDA approves next-gen Watchman FLX Pro from Boston Scientific

The Watchman FLX Pro device. [Image courtesy of Boston Scientific]A string of positive news continues for Boston Scientific (NYSE: BSX) + , which today announced FDA approval for its next-generation Watchman FLX.

Last week, the company reported positive data for its Farapulse system, which led to a favorable reaction from analysts and the market. Just the week before, Boston Scientific received expanded FDA 510(k) clearance for its Visual Ice cryoablation system. Visual Ice’s approval came just weeks after the FDA approved the company’s POLARx cryoablation system for treating paroxysmal AFib.

Watchman FLX Pro, the company’s latest left atrial appendage closure (LAAC) device, further advances Watchman’s performance and safety. It’s indicated for reducing stroke risk in patients with non-valvular AFib (NVAF) who need an alternative to oral anticoagulation therapy.

Boston Scientific designed its next-…

Admetsys wins FDA breakthrough nod for automated glucose control tech

The PrecisionOne system provides automated glucose control and continuous blood diagnostics. [Image from the Admetsys website]Admetsys announced today that it received FDA breakthrough device designation for its automated glucose control system.

The system — also a continuous blood diagnostics system — aims to fill a key gap in the standard of care. Boston-based Admetsys designed it to automatically measure multiple blood analytes, including glucose, in real-time. It requires no patient blood loss.

From the measurement, it creates an adaptive, computational model of each patient’s metabolism. The system evolves with the patient condition, delivering precisely optimized insulin and dextrose treatments through multiple infusion channels.

Get the full story at our sister site, Drug Delivery Business News.

Aion wins FDA clearance for skin-wearable body temperature monitoring device

The iTempShield system received FDA clearance. [Image from Aion Biosystems]Aion Biosystems announced today that it received FDA 510(k) clearance for its iTempShield device and software system.

iTempShield received approval for use in adults and children five years of age and older. It covers use in hospitals, outpatient facilities, remote patient monitoring environments and over-the-counter sales.

Boston-based Aion designed the quarter-sized, skin-wearable monitoring device with support from cloud-based software and proprietary algorithms. It enables the continuous measurement of body temperature for a variety of clinical applications. That includes oncology sepsis monitoring, post-surgical infection detection, long-term monitoring and consumer home health.

The company says iTempShield’s accuracy comes in four times higher than an oral thermometer.

More about the Aion Biosystems iTempShield device

iTempShield adheres to the surface of the skin …