FDA Archives - Page 13 of 103 - Medical Design Sourcing

FDA removes more products from medical device shortages list

The FDA removed more products from its medical device shortages list as supply chain issues from the COVID-19 pandemic continue to improve.

The federal safety agency recently removed devices spanning 17 different product codes, including ventilator products

The products removed from the FDA medical device shortages lists in the latest update were:

Ventilation-related products

The FDA removed three ventilation-related devices from the list: non-continuous ventilators (product code: BZD), non-life-supporting continuous ventilators (product code: MNS) and continuous ventilators with minimal ventilatory support for facility use (product code: MNT).

All had been in short supply due to the global semiconductor shortage and good manufacturing practices requirement compliance. Increase in demand was another factor specific to non-continuous ventilators, which had been in short supply since at least August 2020. The shortage of the two continuous ventilato…

FDA clears MediView augmented reality visualization, navigation platform

The XR90 surgical visualization and navigation platform. [Image courtesy of MediView]MediView XR announced today that it received FDA 510(k) clearance for its XR90 augmented reality-based visualization and navigation platform.

The company designed the surgical platform for adjunctive use in minimally invasive ultrasound and CT-guided needle-based procedures. Cleveland-based MediView said in a news release that its uses include procedures for soft tissue and bone.

“This is not only the first 510(k) clearance for MediView, but it is the first 510(k) clearance for an augmented reality device utilizing live imaging combined with 3D XR visualization for pre- and intra-operative indications for use, which sets the stage for further advancements in augmented reality in the healthcare space.” said Adam Cargill, director of quality, regulatory and clinical affairs at MediView.

More about the MediView XR90 platform

MediView’s augmented reality platf…

Medical device reprocessing design tips from Cardinal Health’s Sustainable Technologies

Medical device reprocessing includes mechanical, chemical and/or electrical processes. [Photo courtesy of Cardinal Health Sustainable Technologies]

Medical device reprocessing is a key focus for Cardinal Health’s Sustainable Technologies business, which collects and cleans single-use devices for safe re-use under FDA standards.

Reprocessed devices keep medical waste out of landfills while offering significantly lower costs than brand-new products for hospitals and other healthcare customers, according to the Association of Medical Device Reprocessors.

Meg McClanahan, chair of the Association of Medical Device Reprocessors Board and global portfolio director for Cardinal Health’s Sustainable Technologies business, offered some advice for designing medical devices for reprocessing.

Previously: Cardinal Health expands single-use device reprocessing facility

What advice can Cardinal He…

Medtronic recalls certain implantable cardiac defibrillators due to potential low energy output

Medtronic Cobalt and Crome ICDs [Image from Medtronic]The FDA designated a recall of some Medtronic (NYSE: MDT) + defibrillators as Class I, the most serious kind.

Medtronic’s recall affects implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Affected products include the Cobalt XT, Cobalt and Crome ICDs and CRT-Ds, plus the Claria MRI, Amplia MRI, Compia MRI, Viva and Brava CRT-Ds. The recall also affects the Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI and Mirro MRI ICDs.

These devices monitor and regulate heart rate and rhythm. They automatically detect and treat life-threatening arrhythmias with electric shock (cardioversion or defibrillation) to restore a normal heartbeat. Some devices also provide cardiac resynchronization therapy to treat heart failure.

Why Medtronic recalled the devices

Medtronic recalled the ICDs and CRT-Ds, manufactured aft…

After recall and relaunch, Medtronic wants to go global with its Harmony valve

Each Medtronic Harmony valve is sewn by hand to attach laser-cut pig tissue to the nitinol that makes this minimally invasive heart implant possible.

Medtronic’s Harmony transcatheter pulmonary valve (TPV) is made of nitinol wire, polyester and laser-cut pig tissue, all sewn together by hand. [Photo courtesy of Medtronic]

Medtronic’s Harmony transcatheter pulmonary valve (TPV) design is paying off after engineers solved a delivery catheter recall and relaunched the system this year.

The Harmony TPV uses pig tissue, shape-memory alloy nitinol and manufacturing techniques old and new to solve a special challenge for children and adults.

The catheter-placed Harmony valve offers a minimally invasive way to improve the flow of blood to the lungs and delay open-heart surgery for congenital heart disease. Congenital heart defects are present in about 40,000 babies born each year, making it the most …

FDA approves drug-coated balloon for BPH symptoms from Urotronic

The Optilume BPH catheter system drug-coated balloon. [Image courtesy of Urotronic]Urotronic announced that the FDA approved its Optilume BPH catheter system for to alleviate urinary symptoms caused by BPH.

Minneapolis-based Urotronic designed Optilume as a minimally invasive surgical therapy. It combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel. This treats lower urinary tract symptoms secondary to BPG (benign prostatic hyperplasia).

Urotronic previously received FDA approval Optilume for the treatment of male urethral strictures. In these cases, the balloon inhibits new scar tissue growth that can occur after endoscopic dilations.

Get the full story at our sister site, Medical Tubing & Extrusion.

FDA updates guidance on paclitaxel-coated devices, determines no link to late mortality risk

The FDA issued healthcare providers updated guidance for certain warning language with paclitaxel-coated devices that treat PAD.

These peripheral arterial disease (PAD)-treating devices produced data that does not support an excess mortality risk. Specifically, the FDA’s guidance eliminates the need for certain warning language in the device labeling.

An FDA panel in 2019 determined that the agency needed more data on these devices to pin down the cause of death. The agency at the time acknowledged that a mortality signal indicated by a meta-analysis exists. The agency then issued a letter to healthcare providers declaring its need for more long-term safety and effectiveness data.

According to the FDA, it now has additional data relating to its previous communications asking for more. The agency said it worked with device manufacturers and external stakeholders to develop the protocol and analysis plan for this new data.

Device manufacturers…

Boston Scientific wins FDA nod for image-guided programming software for deep brain stim

The Vercise Neural Navigator 5 with StimView XT technology. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced today that the FDA approved its Vercise Neural Navigator 5 software.

When used as part of the Vercise Genus deep brain stimulation (DBS) systems, the software offers clinicians simple, actionable data. It enables efficient programming in the treatment of people with Parkinson’s disease or essential tremor.

Vercise Genus delivers targeted electrical stimulation through surgically implanted leads in the brain connected to implantable pulse generators (IPGs). The portfolio received approval for conditional use in a magnetic resonance imaging (MRI) environment in 2021. It consists of Bluetooth-enabled, rechargeable and non-rechargeable, IPGs that power the Vercise Cartesia directional leads.

Boston Scientific’s newly approved software offers the latest addition to the fully in…

FDA clears ECG interpretation software from AccurKardia

AccurKardia announced today that the FDA granted 510(k) clearance for its cloud-based electrocardiogram (ECG) interpretation software.

The AccurECG analysis system, a device-agnostic, fully automated platform, offers a wide range of benefits in ECG interpretation. It features beat-by-beat analysis, ventricular/supraventricular ectopic beat detection and heart rate measurement. The system offers automated interpretation of 13 different heart rhythms, including sinus tachycardia, sinus bradycardia, AFib and atrial flutter.

AccurKardia said that AccurECG provides Lead II analysis of data obtained from compatible ECG devices with wet electrodes. These include Holter monitors, event recorders and/or cardiac telemetry devices. Its fully automated output improves clinicians’ review efficiencies and enables the prompt treatment of patients. AccurKardia says it delivers results in just minutes.

Other benefits include customizable outputs and configurations,…

Better Therapeutics wins FDA nod for type 2 diabetes digital therapeutic

AspyreRx, formerly known as BT-001. [Image from Better Therapeutics website]Better Therapeutics (Nasdaq:BTTX) announced that the FDA authorized its AspyreRx prescription digital therapeutic for diabetes.

AspyreRx, formerly BT-001, provides cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The prescription-only digital therapeutic (PDT) underwent review through the FDA de novo pathway. The company submitted an FDA de novo request in September 2022 for the therapeutic. Earlier this year, it suggested that authorization would come at some point in 2023.

San Francisco-based Better Therapeutics says the authorization creates a new class of diabetes digital behavioral therapeutic devices. The company expects to launch AspyreRx in the fourth quarter of this year.

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

FDA clears Tandem Diabetes Care’s Mobi durable automated insulin pump

The Mobi automated insulin pump with the accompanying mobile app. [Image courtesy of Tandem Diabetes Care]Tandem Diabetes Care (Nasdaq:TNDM) announced today that the FDA cleared its Tandem Mobi automated insulin delivery (AID) system.

Clearance covers people with diabetes ages six and up, expanding the Tandem portfolio of products.

San Diego-based Tandem says Mobi, which is fully controllable from a mobile app, is the world’s smallest durable AID system.

Mobi features a 200-unit insulin cartridge and an on-pump button to provide an alternative to phone control for insulin boluses. It comes in at less than half the size of the existing Tandem pump system, the t:slim X2 pump.

According to the company, it can fit in a coin pocket, clip to clothing or go on the body with an adhesive sleeve.

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

Koru Medical submits infusion system for FDA 510(k) clearance

[Image from Koru Medical Systems]Koru Medical Systems (Nasdaq:KRMD) announced today that it submitted its Freedom60 infusion system for FDA 510(k) clearance.

The submission covers the use of the Freedom60 infusion system with the Hizentra 50 mL prefilled syringe.

In January, Koru inked a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The deal sought to garner regulatory clearance for Freedom Infusion System with an SCIg prefilled syringe. Mahwah, New Jersey-based Koru received FDA approval for the 50 mL Hizentra prefilled syringe in April 2023.

According to the company, Hizentra is the most prescribed subcutaneous immunoglobulin. It’s also the first to be made available in prefilled syringes.

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