FDA Archives - Page 88 of 103 - Medical Design Sourcing

FDA grants EUA for CPAP filter to make devices safer around healthcare workers

PortPatch (Image from Azimuth Sleep Solutions website)

Azimuth Sleep Solutions announced today that it received FDA emergency use authorization (EUA) for its PortPatch product.

PortPatch, a patent-pending product, is designed to expand air filtration capabilities for patient treatment options and to keep healthcare workers safer in patient care areas in which non-invasive ventilatory treatment devices are in use.

Memphis, Tenn.-based Azimuth Sleep Solutions makes the PortPatch with a hydrophobic, N99-rated filter material to filter out 99% of airborne particulates through exhalation ports, anti-asphyxia valves and carbon dioxide vents on CPAP, BiPAP and other non-invasive ventilation masks, according to a news release.

The company said independent test data for the product showed zero retention of carbon dioxide, while PortPatch also remained in place over vents and ports during tests of low-to-very-high levels of airflow pressures.

PortPatch offe…

FDA clears lightweight Inovytec ventilators

(Image from Inovytec)

Inovytec has announced that the FDA has granted FDA 510(k) clearance for its Ventway Sparrow ventilators.

The 2.2 lb. transport and emergency ventilators had previously won FDA emergency authorization for use during the COVID-19 public health emergency. They are already commercialized in Europe, Canada and Australia and are undergoing registration procedures in other countries, according to Ra’anana, Israel-based Inovytec.

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Medtronic wins FDA approval for DiamondTemp ablation system

Medtronic (NYSE:MDT) announced today that it received FDA approval for its DiamondTemp ablation (DTA) system for treating Afib.

Fridley, Minn.-based Medtronic’s DiamondTemp ablation system treats patients with recurrent, symptomatic paroxysmal Afib who have been unresponsive to drug therapy. The medtech giant touts DiamondTemp as the first FDA-approved, temperature-controlled, irrigated radiofrequency ablation system with diamonds currently available to deliver ablations.

DiamondTemp delivers radiofrequency energy (heat) during ablations with real-time feedback on physical parameters to guide physicians as the lesion is being produced.

Embedded with industrial-grade diamonds with 200-400 times greater thermal conductivity compared to materials used in standard radiofrequency ablation catheters, the DiamondTemp ablation catheter offers thermal conductivity to enable a low irrigation flow-rate, as well as real-time measurements of tissue temperature,…

10 medtech hazards you need to watch out for in 2021

(Image by Антон Дмитриев on Unsplash)

Patient safety organization ECRI comes out with its list of health technology hazards every year, and it often contains the same issues. The COVID-19 pandemic has changed much of that.

The nonprofit organization is focusing this year on the need to move from trying to cope during an emergency to building stronger and more resilient processes, using the innovations developed during the pandemic and the lessons learned along the way.

ECRI engineers, scientists, clinicians and other patient safety analysts nominate topics for the list based on their own expertise and insight gained through:

Investigating incidents. Testing medical devices in the ECRI lab. Observing operations and assessing hospital practices. Reviewing the literature. Speaking with clinicians, clinical engineers, technology managers, purchasing staff, health systems administrators, and device suppliers.

The ECRI staff also considers the thousands of h…

House committee investigates $70M federal contract for AutoMedx ventilators

The AutoMedx SAVe II+ ventilator (Image from AutoMedx)

A Congressional committee has launched an investigation into a $70 million White House contract for ventilators that reportedly are inadequate to treat people with COVID-19.

The Department of Defense signed a $16.2 million contract in spring 2020 to buy SAVe II ventilators, manufactured by AutoMedx (Addison, Tex.), from the supplier Combat Medical Systems, according to the House Committee on Oversight and Reform. Soon after this contract was signed, officials at the Department of Health and Human Services (HHS) reportedly concluded that the SAVe II ventilator model was inadequate to treat coronavirus patients, a news release from the committee says.

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FDA clears Aerobiotix system to clean air inside hospitals

Aerobiotix announced today that it received FDA 510(k) clearance for its Aerocure-MD medical air purification system.

Miamisburg, Ohio-based Aerobiotix’s Aerocure-MD platform received FDA labeling to destroy microorganisms in the air by exposure to ultraviolet radiation and also remove particles in from the air via HEPA filtration, according to a news release.

Aerocure-MD is designed for mobile, high-volume air decontamination applications in healthcare spaces including acute care areas, contaminated storage and handling areas and long-term healthcare facilities. The system uses a shielded internal ultraviolet system to prevent potentially hazardous exposure of personnel and material to ultraviolet rays.

The company said it submitted independent data demonstrating effectiveness against viral and bacterial aerosols, along with particulate contamination to support clearance.

“This clearance represents an important regulatory validation of our …

FDA clears Theranica device for adolescent migraines

(Image courtesy of Theranica)

Theranica announced today that the FDA has granted expanded clearance for the use of its Nerivio acute migraine treatment device by people 12 years and older.

The use of the device in the treatment of adolescents is supported by a study recently published in Headache. According to the study, 28 of 39 (71%) of the adolescent participants using Nerivio experienced pain relief after two hours while 35% experienced complete freedom from pain. Pain relief and pain freedom were sustained for 24 hours in 90% of cases. Sixty-nine percent of the patients experienced improvement in their functional ability, defined by the ability to do schoolwork and perform “usual activities,” at two hours. There were no device-related serious adverse events.

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FDA says to limit mask decontamination to 4 cycles

(Image courtesy of Brian McGowan on Unsplash)

Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times.

The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major media organizations and nurses began to question the claims about the number of times an FFR could be safely decontaminated and reused. Companies, universities and other organizations gained EUAs for sterilizing masks up to 10 times (Sterilucent and Steris), and Stryker (up to two times), with a total of 13 organizations now holding 15 such EUAs.

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7 core strategies in Biden’s battle against COVID-19

[Photo by Fusion Medical Animation on Unsplash]

Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts.

Also included are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential.

The “full-scale, wartime” plans have considerable relevance for the pharmaceutical and medical device industries. (More information is available on the medical-device ramifications of the plan from our sister site, Medical Design & Outsourcing.)

While the plan stands out from the prior administration’s COVID-19 response in its detail and earnestness, several portions effectively represent a continuation of existing policy. The policy, for instance, says it will end the U.S. government’s practice of stockpil…

FDA approves Boston Scientific Vercise Genus deep brain stimulation system

Boston Scientific (NYSE:BSX) announced today that it received FDA approval for its fourth-generation Vercise Genus DBS system.

Marlborough, Mass.-based Boston Scientific’s Vercise Genus deep brain stimulation (DBS) system portfolio is approved for conditional use in a magnetic resonance imaging (MRI) environment. It features a family of Bluetooth-enabled, rechargeable and non-rechargeable implantable pulse generators capable of powering Cartesia directional leads to offer symptom relief for those suffering from Parkinson’s disease, according to a news release.

The fourth generation of the platform, Vercise Genus features increased battery life and improved directionality and stimulation capabilities as the Brainlab platform offers enhanced visualization capabilities for physicians to see lead placement within the context of each patient’s segmented target anatomy.

Vercise Genus is indicated for use in the bilateral stimulation of the su…

Eitan Medical lands FDA clearance for infusion pump system upgrade

Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories.

The Sapphire infusion system is the company’s flagship infusion device and is used across the U.S. within alternate sites, homecare markets, emergency medical services and hospitals.

The compact Sapphire infusion pump is designed to deliver a wide range of therapies for varied clinical uses, such as saline, total parenteral nutrition, lipids, IV medication, perineural medication, epidural medication, blood and blood products. It has a color touch screen for intuitive and fast operation, built-in safety mechanisms and technology designed to minimize dosage errors and false alarms.

The most recent hardware and software upgrade adds a number of improvements, including:

A perineural route intended to support a wider range …

HHS could make permanent pandemic-related exemptions for some devices

HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process.

In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance.

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