covid-19 Archives - Page 106 of 113 - Medical Design Sourcing

Cantel Medical up on Street-beating Q3

Cantel Medical (NYSE:CMD) shares ticked up today on third-quarter financial results that came in ahead of the consensus forecast.

The Little Falls, N.J.-based company posted profits of $15.8 million, or 37¢ per share, on sales of $236.9 million for the three months ended April 30, 2020, for a 93.1% bottom-line gain on sales growth of 3.7%.

Adjusted to exclude one-time items, earnings per share were 16¢, 4¢ ahead of Wall Street, where analysts were looking for sales of $235.4 million.

Cantel Medical said in a news release that a decline in organic sales came as a result of the reduction of elective procedures caused by the COVID-19 pandemic, which mostly affected the last five weeks of the third quarter. Adjusted earnings per share dropped from 55¢ in the third quarter of 2019 in a trend that was driven by the effects of the pandemic.

The company said its medical and dental segments were primarily impacted, although most impacts were offset by a fa…

NASA, Fitbit gain EUAs for COVID-19 devices

The FDA granted emergency use authorization (EUA) for emergency COVID-19 ventilator devices developed by Nasa and Fitbit (NYSE:FIT).

According to the FDA’s ongoing list of devices granted EUAs, both devices were authorized on June 1. NASA’s VITAL (ventilator intervention technology accessible locally) compressor and the Fitbit Flow are the latest of a few ventilator alternatives to garner EUA status.

NASA’s VITAL compressor is designed to offer continuous ventilatory support for adult patients requiring ventilation when no standard ventilators are available. It is a restricted device intended for use by a qualified healthcare provider.

The VITAL compressor is the second NASA ventilator to earn EUA, after the original VITAL device obtained authorization last month. NASA touts VITAL as capable of being built faster and maintained more easily than a traditional ventilator. The device includes fewer parts than other ventilators, many of whi…

Canada orders 37 million syringes from BD in anticipation of COVID-19 vaccine

Canada reportedly signed a contract to purchase 37 million syringes from Becton Dickinson (NYSE:BDX) in preparation for a potential COVID-19 vaccine.

A report in The Record revealed that Public Services & Procurement Minister Anita Anand said the country made a purchase order from the Canadian branch of BD in an effort to make sure Canada is ready for mass vaccinations if the cure for COVID-19 is discovered. There is no definitive timeline for the delivery of the syringes as of now.

Get the full story at our sister site, MassDevice.

Canada orders 37 million syringes from BD in anticipation of COVID-19 vaccine

Canada reportedly signed a contract to purchase 37 million syringes from Becton Dickinson (NYSE:BDX) in preparation for a potential COVID-19 vaccine.

A report in The Record revealed that Public Services & Procurement Minister Anita Anand said the country made a purchase order from the Canadian branch of BD in an effort to make sure Canada is ready for mass vaccinations if the cure for COVID-19 is discovered. There is no definitive timeline for the delivery of the syringes as of now.

Get the full story on our sister site MassDevice.

Canada orders 37 million syringes from BD in anticipation of COVID-19 vaccine

Canada reportedly signed a contract to purchase 37 million syringes from Becton Dickinson (NYSE:BDX) in preparation for a potential COVID-19 vaccine.

A report in The Record revealed that Public Services & Procurement Minister Anita Anand said the country made a purchase order from the Canadian branch of BD in an effort to make sure Canada is ready for mass vaccinations if the cure for COVID-19 is discovered. There is no definitive timeline for the delivery of the syringes as of now.

The Record cited Statistics Canada as reporting that more than 38 million people comprise the country’s population, one million more than the total number of syringes agreed upon in the contract. Canada Chief Public Health Officer Theresa Tam said the order represents the “maximum number of Canadians who may wish to be vaccinated,” according to the report.

Currently, Chinese pharmaceutical company CanSino Biologics is collabo…

U of M releases Coventor ventilator design as open-source

The University of Minnesota recently announced that it released the design for its Coventor alternative ventilator as open-source.

Minnesota’s Coventor low-cost device gained notoriety in March after researchers touted the design made from various parts totaling just $150. In April, it became the first ventilator of its kind authorized for use under the FDA’s EUA for the COVID-19 pandemic.

Also in April, Boston Scientific (NYSE:BSX) announced that it was sole manufacturer of the device, which the company said it expects to sell at-cost at approximately $1,000 per unit.

The Coventor is now available to companies who are interested in manufacturing it. They can sign a free electronic license and download the manufacturing specifications.

“From the outset, the mission of this project was to make this emergency device available to people in need, wherever they might be in the world, as quickly and safely as possible,” Dr. Stephen Richardson, a…

FDA streamlines at-home COVID-19 test applications

The FDA has added a method to streamline COVID-19 diagnostic test manufacturers’ efforts to apply for an emergency use authorization (EUA) for home sample collection.

The new template on the FDA website includes recommendations for laboratories and commercial manufacturers to use in preparing and submitting an EUA request. Currently, developers can offer a COVID-19 test for at-home self-collection under emergency use authorization (EUA), and COVID-19 tests for at-home self-collection may also be used as part of an (IRB)-approved study.

The FDA has authorized several COVID-19 tests for use with at-home collection of samples that can be sent to a lab for processing and test reporting. The agency said it is also aware of developers who are conducting Institutional Review Board-approved studies of COVID-19 tests that use at-home collection of test samples. No tests are authorized to be used completely at-home.

“During this pandemic, the FDA has …

Battelle under fire for decontamination system performance

Contaminated shipment of personal protective equipment delivered for Battelle CCDS decontamination system (Image from Battelle)

Major media outlets are questioning the ability of the Battelle Critical Care Decontamination System (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed.

The FDA granted the nonprofit tech development company an emergency use authorization in March for its vaporized hydrogen peroxide system to decontaminate N95 respirators used by healthcare providers during the COVID-19 pandemic.

Nurses and nurses’ organizations have complained that respirators reprocessed by Battelle’s system began to fail after far fewer than the 20 cycles the company claims is safe, according to reports by NBC and the Boston Globe.

In April, National Institutes of Health scientists said N95 respirators can be decontaminated effectively and maintain…

Philips wins EUA for acute-care patient monitoring

Royal Philips (NYSE:PHG) announced today that it received FDA emergency use authorization (EUA) for its IntelliVue patient monitors and active displays.

The Amsterdam-based company’s IntelliVue monitors MX750/MX850 and active displays AD75/D85 received authorization to support infection-control protocols and provide caregivers information remotely during the ongoing COVID-19 pandemic.

Both sets of IntelliVue products received CE Mark approval last year and the MX750 patient monitor already received EUA in April. The latest EUA allows Philips to begin delivering the remote monitoring products to hospitals in the U.S., while it is preparing to submit to the FDA for 510(k) clearance this year.

The monitors and active displays include Philips’ IntelliVue Horizon Trends information view that shows deviations in vital signs. It also features an alarm advisor and alarm reporting to reduce caregivers’ alarm fatigue. Philips noted in a news rele…

BD furloughs 160 employees at Nebraska plant

Becton Dickinson (NYSE:BDX) reportedly furloughed 160 employees at its Broken Bow, Neb. plant amid the COVID-19-induced dip in demand for certain healthcare products and procedures.

A report in the Sandhills Express said BD’s PR associate director of reputation management Gwen Gordon confirmed that operations will resume as soon as possible in Broken Bow, but the furlough is likely to last anywhere between four and seven weeks.

Along with the 160 employees furloughed out of nearly 600 in total, Gordon confirmed to the Sandhills Express that about 30 temporary workers at the Broken Bow facility will be released from their temporary work assignments.

Gordon told the news outlet that the furlough is a result if heightened demand for products used in diagnosing and treating COVID-19. BD’s areas of production that aren’t directly related to COVID-19 have been put on pause, resulting in the furloughs and reduced work schedules.

While B…

Lille Group releases of Cardiac Signals cloud-based patient monitoring software

Lille Group announced today that it launched its Cardiac Signals cloud-based software platform for healthcare professionals to monitor cardiac patients remotely.

The secure platform enables cardiology practices and hospitals to manage cardiac patients remotely with ease and efficiency, which is aimed to help during a potential telehealth boom as the COVID-19 pandemic continues and onsite clinics are forced to delay patient care. It not only enables remote management in lieu of in-person visits, but also helps at-risk patients whose cardiac conditions could cause serious complications if they contract coronavirus.

Albany, N.Y.-based Lille Group’s platform can be integrated into any electronic health record system, or used in a stand-alone mode with any major internet browser, according to a news release. It also captures all billable events.

The company said thousands of patients have already been managed with the platform thr…

Medtronic is making its ‘artificial lung’ therapy available for COVID-19 treatment

The Medtronic Affinity CP centrifugal blood pump [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) is temporarily modifying product indications so that health providers can use its extracorporeal membrane oxygenation (ECMO) technology to treat people with severe cases of COVID-19.

ECMO could be described as a type of “artificial lung” technology that pumps blood from a person’s body to an oxygenator that provides long-term oxygen and carbon-dioxide transfer. Medtronic has devices that are FDA-cleared for extracorporeal support of up to 6 hours — an appropriate amount of time for cardiopulmonary bypass procedures (up to 6 hours).

Get the full story on our sister site Medical Design & Outsourcing.