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.…

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ICU Medical recalls certain infusion pump replacement batteries

The Plum 360 infusion system. [Image from ICU Medical]The FDA issued a notice determining that the recall of ICU Medical (Nasdaq:ICUI) infusion pump batteries is Class I, the most serious kind.

ICU Medical initiated a recall of replacement batteries for certain infusion systems on March 22, 2023. The recall affects its Plum 360, Plum A+ and Plum A+3 infusion systems.

The infusion systems provide fluid to patients in precisely controlled infusion amounts and rates. They deliver blood or blood products, drugs and other fluid mixtures through subcutaneous, intramuscular, intravenous, and intrathecal administration. Their batteries and replacement batteries are used when the pump is not plugged into AC power. An example of this occurs during patient transport.

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FDA clears automated insulin pump from Beta Bionics for type 1 diabetes

The FDA announced today that it cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software.

FDA clearance covers the devices for people 6 years of age and older with type 1 diabetes. Combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), they form the iLet Bionic Pancreas. Using an algorithm, the automated insulin delivery system determines and commands insulin delivery.

Interim CEO and board member Martha Aronson last year told Drug Delivery Business News recently that the iLet will help those with diabetes reduce the cognitive burden of managing their disease.

“Today’s action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to advancing new …

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Virtual Incision submits surgical robot for FDA de novo clearance

[Image from Virtual Incision]Virtual Incision announced that it submitted its MIRA surgical robot to the FDA for de novo clearance review.

Lincoln, Nebraska-based Virtual Incision seeks authorization to market MIRA for use in bowel resection procedures. The submission follows a completed FDA investigational device exemption (IDE) study. FDA approved the IDE supplement for MIRA in April 2022.

MIRA could become the first robot-assisted surgery device to garner de novo clearance for bowel resection procedures. Virtual Incision says this would make it a “trailblazer” in soft tissue robotics. Clearance could also lay the foundations for expanded procedural indications, the company said.

Virtual Incision may look to build on de novo clearance with entry into international markets, the addition of instruments and accessories and the development of future generations for MIRA.

The company plans for a limited launch in the U.S. if it obtains marke…

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Paradromics raises $33M, wins FDA breakthrough nod for brain-computer interface tech

The Connexus DDI brain-computer interface. [Image courtesy of Paradromics]Paradromics announced today that it raised $33 million in a Series A funding round and garnered an FDA breakthrough device designation.

Austin, Texas-based Paradromics develops a high data-rate brain-computer interface (BCI). The company sees its latest financial and regulatory progress as a positive step into the competitive BCI market.

Paradromics plans to use the funding to launch its first-in-human clinical trial for the Connexus direct data interface (DDI).

The Connexus DDI, which received the breakthrough nod, enables communication for people with conditions like ALS, spinal cord injury and stroke. These conditions may cause severe motor impairment, affecting the patients’ ability to communicate.

Connexus DDI’s first application translates brain signals into speech and movement in real time. The assistive communication device restores social connection and ena…

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FDA clears insertable cardiac monitor from Abbott

The Assert-IQ insertable cardiac monitor. [Image courtesy of Abbott]Abbott (NYSE:ABT) today announced that it received FDA clearance for its Assert-IQ insertable cardiac monitor (ICM).

The Assert-IQ device offers a new option for diagnostic evaluation and long-term monitoring for irregular heartbeats. It supplements Abbott’s portfolio fo connected health devices for managing and treating patients remotely.

A small device with sensors inserted just under the skin of the chest, Assert-IQ provides constant, real-time monitoring. It can detect and identify arrhythmias that lead to symptoms like fainting, irregular pulse and shortness of breath. Abbott says many commercially available ICMs monitor hearts for “a few years,” but Assert-IQ offers two options. With a battery life of at least three or six years, it can provide doctors with a new level of flexibility in diagnostic monitoring.

The three-year option offers a method for more traditional…

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FDA clears AI software for MRSA diagnostics from BD

The BD Kiestra MRSA imaging app powered by AI. [Image courtesy of BD]BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its new Kiestra imaging application that uses AI.

The Kiestra methicillin-resistant staphylococcus aureus (MRSA) imaging application uses AI to interpret bacterial growth and release negative specimens with minimal human interaction.

Franklin Lakes, New Jersey-based BD designed the Kiestra MRSA application to utilize AI to automate this inspection process. These traditionally require labor- and time-intensive inspections of Petri dishes to determine if bacterial growth occurred. With Kiestra’s automation capabilities, scientists and technicians can spend more time on higher-value analysis.

BD said in a news release that the application can evaluate single specimens or group together large volumes. That could help reduce the administrative burden on technicians, the company added.

The MRSA imaging applicati…

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FDA’s mandatory medical device shortage reporting ends

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

Reporting of medical device shortages to the FDA is no longer mandatory with last week’s expiration of the COVID-19 public health emergency.

Manufacturers can still voluntarily report device production interruptions or permanent discontinuations to the FDA. Patients, healthcare providers, healthcare systems and other stakeholders can also notify the FDA of any supply chain disruptions they’re experiencing by emailing patients, healthcare providers, healthcare systems, distributors, group purchasing organizations) experiencing supply chain disruptions may also notify the FDA by emailing deviceshortages@fda.hhs.gov.

“The FDA encourages device…

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FDA approves expanded label for Abbott Eterna spinal cord stimulation tech

The Eterna spinal cord stimulation (SCS) system [Image courtesy of Abbott]Abbott (NYSE:ABT) announced today that the FDA approved expanded MRI labeling for its Eterna spinal cord stimulation (SCS) system.

The expanded labeling includes new leads that are MR conditional. It means people with chronic pain can undergo MRI scans within approved, outlined conditions with a wider selection of lead options for full-body scans. Eterna SCS with TotalScan MRI now provides fully-body MRI capabilities. It also features normal operating mode scanning with select leads.

FDA approved Eterna in December 2022.

Abbott cited recent findings from its own study demonstrating that 93% of surgeons consider MRI accessibility an important to essential factor when determining the best SCS system for their patients. This study also revealed that surgeons place a high value on the ability to implant leads in the epidural space. Those surgeons want to accomplish this while still remain…

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Cue Health submits RSV molecular test to FDA for de novo clearance

Cue Health (Nasdaq:HLTH) announced today that it made a de novo submission to the FDA for clearance of its RSV molecular test.

The submission aims to garner full clearance of the test for at-home and point-of-care use. According to Cue Health, no respiratory syncytial virus (RSV) tests exist on the market for home use. Pending FDA clearance, the test could provide a first at-home molecular RSV test for use on people of all ages.

Cue’s RSV molecular test cartridge uses a lower nasal swab. It features compatibility with the Cue Reader, which communicates results digitally via Bluetooth. It can communicate these results in approximately 25 minutes.

“Both young children and older adults are at high risk for severe RSV infection, which includes symptoms similar to the flu, COVID-19, and the common cold, but has a distinct plan for managing care,” said Dr. David Tsay, chief medical officer for Cue Health. “This makes early detection of the virus even mor…

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How Siemens will accelerate adoption of Scopio’s AI-powered telehematology tech

Scopio’s partnership with Siemens Healthineers will “accelerate digital workflow transformation in hematology laboratories worldwide,” Scopio CEO Itai Hayut said. [Photo courtesy of Siemens Healthineers]

Scopio Labs has enlisted a huge partner to get its telehematology technology into more labs.

Scopio and Siemens Healthineers today announced a global distribution deal for the Scopio X100 and Scopio X100HT.

Siemens said those full-field digital cell morphology technology systems will complement its own Atellica HEMA 570 and Atellica HEMA 580 analyzers to give labs “high-resolution, full-field viewing for peripheral blood specimens and artificial intelligence-based morphological analysis with remote capabilities through the secure hospital network.”

Siemens Healthineers Head of Diagnostics Sharon Bracken called the deal “a step forward in delivering automated and…

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FDA approves ophthalmic spray from Eyenovia

[Image courtesy of Eyenovia]Eyenovia (Nasdaq:EYEN) announced today that the FDA approved its Mydcombi treatment for use with the Optejet delivery device.

New York-based Eyenovia designed Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. It marks the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S.

Eyenovia said it also represents the first product using Eyenovia’s proprietary Optejet device to receive any regulatory approval.

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