FDA Archives - Page 15 of 103 - Medical Design Sourcing

FDA clears OCD therapy from Neuronetics

[Image from Neuronetics]Neuronetics (Nasdaq:STIM) announced today that it received FDA 510(k) clearance for its obsessive-compulsive disorder treatment.

The FDA cleared the company’s OCD motor threshold (MT) cap technology for NeuroStar advanced therapy for mental health.

According to a news release, determining a patient’s MT represents a critical step to establishing their prescription before starting treatment. NeuroStar, a transcranial magnetic stimulation (TMS) system, holds FDA clearance for MT caps for both OCD and major depressive disorder.

The MT cap simplifies the initial NeuroStar placement, Neuronetics says. It provides a consistent starting location and a step-by-step process to map a patient’s motor cortex. This effectively shortens the time needed and reduces the number of steps involved in the process.

Neuronetics said its MT cap features compatibility with Fast MT, providing up to 40% time savings for clinicians and…

NeuroOne submits RF ablation system for FDA 510(k) clearance

NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it submitted an FDA 510(k) application for its OneRF ablation system.

This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator. NeuroOne’s electrodes provide a similar function at the subsurface level of the brain compared to cortical electrodes. However, they utilize a much less invasive process. That process eliminates the need to remove the top portion of the skull.

NeuroOne said FDA clearance would mark the first step in bringing an RF ablation system to market for neurology and neurosurgery. It’s the company’s first therapeutic device. The company commercially launched its Evo sEEG electrode line in the U.S. earlier this month. The electrodes provide up to 30 days of recording, monitoring and stimulation of electrical signals at the subsurface level of the b…

Inspire Medical wins expanded FDA approval for sleep apnea therapy

Inspire Medical Systems (NYSE:INSP) announced today that the FDA approved an expanded indication for its sleep apnea therapy.

Minneapolis-based Inspire develops minimally invasive solutions for patients with obstructive sleep apnea (OSA). The proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that treats moderate to severe OSA. It offers an alternative to traditional positive airway pressure (PAP) therapy in the sleep respiratory market.

The expanded indication includes an increase on the upper limit of the Apnea Hypopnea Index (AHI). It raises the number of events per hour from 65 to 100. FDA also approved an increase in the Body Mass Index (BMI) warning in the labeling, changing from 40 to 32.

“We are excited that the FDA has approved Inspire’s application to expand our indication to include patients with AHI up to 100 events per hour. These patients experience severe OSA and have historically had limited treatme…

Q&A with John Mazzola, Vicarious Surgical’s first chief operations officer

Vicarious Surgical Chief Operating Officer John Mazzola [Photo courtesy of Vicarious Surgical]

Capping off a medtech career spanning more than three decades, John Mazzola had only been retired from Becton Dickinson for about a week when Vicarious Surgical co-founder and CEO Adam Sachs hired him to lead strategic manufacturing planning.

One year later, the surgical robotics developer has promoted Mazzola to the newly created position of chief operating officer, covering product development, manufacturing, supply chain, quality, clinical, regulatory, IT, people and culture.

Related: Surgical robotics trends and how to accelerate adoption

Mazzola spoke with Medical Design & Outsourcing about the latest from Waltham, Massachusetts-based Vicarous Surgical (NYSE: RBOT), its plans for manufacturing and outsourcing, the company’s recent layoffs and lessons learned about developing and launching …

Sterilization startup Phiex adds ex-Medtronic chief medical and scientific officer as advisor

Phiex advisor Dr. Rick Kuntz was formerly Medtronic’s chief medical and scientific officer. [Photo courtesy o Kuntz]

Retired Medtronic Chief Medical and Scientific Officer Dr. Rick Kuntz has joined Phiex as an advisor as the medical device sterilization startup works toward commercialization.

Phiex is developing a new method for medical device sterilization using dry powder that generates chlorine dioxide gas inside product packaging.

The company sees a big opportunity to offer an alternative to ethylene oxide (EtO) sterilization, which is the most commonly used method in medtech but faces new safety regulations over health risk concerns.

“It’s clear that EtO’s going to have to go away. It’s just not going to be tolerated … and I just think this is the best alternative,” Kuntz said today in an interview with Medical Design & Outsourcing.

Kuntz j…

FDA clears Teleflex’s Wattson temporary pacing guidewire

Teleflex (NYSE:TFX) announced today that it received FDA clearance for its Wattson temporary pacing guidewire for use in heart procedures.

Wayne, Pennsylvania-based Teleflex says it’s the first commercially available bipolar temporary pacing guidewire designed specifically for use during TAVR and BAV. The company plans to feature Wattson at TVT: The Structural Heart Summit, June 7-10 in Phoenix.

Wattson features dual functionality, supporting both valve delivery and ventricular bipolar pacing. It offers a procedural alternative to help avoid a variety of complications, steps and costs associated with right ventricular pacing.

Teleflex said it designed Wattson with a flexible distal pigtail shape and multiple electrodes for bipolar capabilities. It helps reduce the risk of ventricular perforation while providing confidence in capture during rapid pacing.

The company intends to launch the Wattson temporary pacing guidewire in a limited market …

Cue Health wins FDA de novo authorization for home COVID-19 test

The Cue Reader for the company’s COVID-19 test. [Image courtesy of Cue Health]Cue Health (Nasdaq:HLTH) announced that it received FDA de novo authorization for its Cue COVID-19 molecular test.

San Diego-based Cue Health designed the test for both home and point-of-care use. Its authorization marks the first such nod for a home-use COVID-19 test, the company said. It also represents the first de novo authorization for any home-use respiratory test, according to a news release.

Cue Health originally made its COVID-19 test available to consumers without a prescription in 2021. That availability came under the FDA’s emergency use authorization (EUA), a widely used pathway for COVID-19-related products.

The molecular test delivers results in just 20 minutes to connected mobile smart devices. It demonstrated overall accuracy of 98%, detecting all known COVID-19 variants of concern. The test also integrates into Cue Care, the company’s state-of-t…

iRhythm’s FDA warning letter details alleged violations and patient deaths

The iRhythm Zio AT [Image courtesy of iRhythm]An FDA warning letter made public today accused iRhythm Technologies (Nasdaq: IRTC) + of violations of the Federal Food, Drug, and Cosmetic Act’s rules for labeling, quality systems and medical device reporting.

In at least two cases, iRhythm did not report patient deaths in the required 30-day window, and instead reported them the following year, the FDA said.

The FDA issued the warning letter on May 25, 2023, following an inspection of the company’s facility in Cypress, California, in July and August 2022. The alleged violations concern iRhythm’s Zio AT electrocardiogram (ECG) monitoring system, which includes the Zeus software reporting system. The FDA cleared the system in 2017 under the 510(k) pathway.

Previously: iRhythm faces another subpoena from the DOJ

While the FDA said some of iRhythm’s responses and corrective actions have been…

Teleflex Arrow EZ-IO needle cleared for use in MRI

The Arrow EZ-IO system. [Image from Teleflex]Teleflex (NYSE:TFX) announced today that it received FDA 510(k) clearance for its Arrow EZ-IO needle for MR conditional labeling.

Wayne, Pennsylvania-based Teleflex said the regulatory nod makes the needle the first and only intraosseous needle with 510(k) clearance.

The EZ-IO needle represents a critical component of Teleflex’s Arrow EZ-IO intraosseous vascular access system. It features a patented diamond tip for fast, precise and steady insertion. The system can be used when intravenous access is difficult or impossible to obtain in emergent, urgent or medically necessary cases.

New labeling enables the clinician to care for patients requiring MRI scans without interrupting the established vascular access site. Michelle Fox, Teleflex VP and chief medical officer, said it provides an additional vascular access option for those requiring MRI.

“Teleflex continues to innovate on behalf of clinicians w…

Masimo wins FDA clearance for wearable vital sign monitor

The Radius VSM system. [Image courtesy of Masimo]Masimo (Nasdaq:MASI) announced today that the FDA cleared its Radius VSM patient-worn, continuous, multi-parameter vital signs monitor.

Radius VSM enables physicians to monitor a range of physiological measurements. That includes Masimo SET pulse oximetry, noninvasive blood pressure, temperature, respiration rate and ECG.

Masimo said its monitor combines the reliability and accuracy of larger bedside monitors with the comfort and freedom of wearable devices. It enables ambulation and movement while ensuring patients remain continuously monitored. The company said it has the scalability to match each patient’s unique monitoring needs and level of acuity.

About the Masimo Radius VSM

Radius VSM, a modular, wearable device, enables providers to equip any hospital bed with comprehensive monitoring. They can quickly add or remove measurement technologies to match each monitoring scenario, leading to more pers…

Abiomed recalls some Impella 5.5 with SmartAssist devices

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]The FDA today issued a field safety notice deeming a recall of Abiomed Impella 5.5 heart pumps as Class I, the most serious kind.

Abiomed — bought by Johnson & Johnson for $16.6 billion last year — recalled 466 affected devices. It distributed these Impella 5.5 with SmartAssist devices between Sept. 28, 2021, and March 6, 2023. The company initiated its recall on April 17. 2023.

This recall affects a subset of Impella 5.5 with Smart Assist systems. The latest versions with a preinstalled sidearm retainer and new yellow luer remain unaffected by this recall.

Impella 5.5 with SmartAssist supports the pumping chambers of the heart for up to 14 days when cardiogenic shock occurs less than 48 hours after a severe heart attack, open-heart surgery or when the heart functions poorly due to cardiomyopathy. Abiomed received customer complaints around the devic…

FDA approves Zoll therapy for sleep apnea with MRI

The Remedē EL X sleep apnea therapy. [Image from Zoll]Zoll Medical announced that it received FDA approval for its Remedē system for conditional use with magnetic resonance imaging (MRI).

Chelmsford, Massachusetts-based Zoll designed its Remedē system as an implantable, transvenous phrenic nerve stimulation therapy. It treats adults with moderate to severe central sleep apnea (CSA). Full-body MRI approval applies to all models of the system and covers new patients as well as existing ones.

Dr. Asim Roy, medical director of the Ohio Sleep Medicine Institute, said in a news release that CSA patients often suffer from other co-morbidities. These comorbidities may benefit from MRI scanning, including brain, spine and joint issues.

Remedē initially received FDA approval in 2017. The implantable device activates automatically each night to simulate the phrenic nerve in the chest. This sends signals to the diaphragm to help restore a more normal breathing pattern.…