Search This Blog

Saturday, May 2, 2020

NASA will license its FDA-approved ventilator to manufacturers for free


NASA's JPL-developed VITAL ventilator
A new high-pressure ventilator developed by NASA engineers and designed to treat COVID-19 has received FDA approval via a fast-tracked emergency use authorization. Now, NASA is looking for a medical industry partner to manufacture the device. It will license the tech on a royalty-free basis during the pandemic.
Engineers from NASA’s Jet Propulsion Laboratory (JPL) developed VITAL (Ventilator Intervention Technology Accessible Locally) in just 37 days. It has been tested successfully on a “high fidelity human patient simulator” at the Icahn School of Medicine at Mount Sinai in New York.
“Now that we have a design, we’re working to pass the baton to the medical community, and ultimately patients, as quickly as possible,” said Fred Farina, chief innovation and corporate partnerships officer at Caltech.
The design offers a few key benefits. NASA says it can be built faster and maintained more easily than traditional ventilators. It is composed of fewer parts, which are currently available through existing supply chains, and it can be modified for use in field hospitals like the ones being set up in convention centers. The device is built to last three to four months, so it won’t replace the current hospital ventilators, but it could fill critical shortages.
JPL doesn’t typically design medical equipment, but in a video, several engineers expressed a desire to use their skills to help address the COVID-19 pandemic. This is part of a growing trend of technologists trying to meet the demand for ventilators. We’ve seen right-to-repair campaigns, as well as ventilators made with gaming PC cases and Tesla parts. We’ve also learned, though, that while making ventilators is relatively easy, pivoting manufacturing to do so is more difficult.
“This ventilator is one of countless examples of how taxpayer investments in space exploration — the skills, expertise and knowledge collected over decades of pushing boundaries and achieving firsts for humanity — translate into advancements that improve life on Earth,” NASA Administrator Jim Bridenstine said in a statement.
https://www.engadget.com/nasa-jpl-ventilator-fda-approval-221346849.html

NY ‘quietly’ conducting coronavirus tests at grocery stores

Gov. Cuomo has quietly begun recruiting grocery stores in a bid to widen the state’s coronavirus testing program, The Post has learned.
Tests for the deadly bug — a key tool for pinpointing infection hotspots as officials look to ease lockdowns — are now being administered at an undisclosed number of supermarkets statewide as officials look to reach a larger swath of the Empire State’s population, officials confirmed.
Among those participating are several Fine Fare supermarkets in the Bronx and Brooklyn, each of which has administered upwards of 200 antibody tests a day inside the stores, said Rudy Fuertes, president of Fteley Food Corp., which operates 10 Fine Fare locations in the Big Apple.
The supermarket tests have been conducted quietly, with no announcement by the governor’s office, Fuertes told The Post.
“They don’t tell anyone they are doing that — otherwise we’d have lines through the kazoo,” said Fuertes, who says he tested positive for the virus but had no symptoms.
The antibody tests — first launched last month at hospitals for first responders, health care workers and hospital patients — started rolling out at Big Apple urgent-care clinics earlier this week. The governor has likewise cut red tape to begin testing at more than 5,000 independent drugstores statewide this weekend.
In the meantime, however, the state’s Department of Health also has been focusing on a random sampling of the population: people who shop and work at supermarkets.
State health workers are setting up shop at long tables inside the stores, administering tests that draw blood from five fingers. The results are sent directly to participants via e-mail or a phone call.
Other supermarkets across the state are also participating in the program, though a health official declined to identify those companies or the specific stores.
“The governor has talked about testing as one of the keys to reopening the state,” a department of health official said. “The supermarkets are the random testing piece” of this effort.
State officials said they have tested some 8,000 people over the past two weeks, including 3,000 random samples from the general population.
Fine Fare’s Fuertes believes about 30 percent of his employees tested positive for coronavirus based on the fact that nearly 100 percent of his managers in each store tested positive.
His stores in the Bronx at 1221 Fteley Avenue and at 459 E. 149th St. were testing sites last week. Testing sites also were set up at the Key Food in Williamsburg this week, also owned by Fteley.
Cuomo said this week that nearly a quarter of New York City residents have had coronavirus. Infection rates in Westchester and Rockland counties have run at 15.1 percent as of this week. Long Island had a 14.4 percent infection rate. Outside of those regions, the state average is 3.2 percent, officials said.
“The tests are bringing hope to our community,” Fuertes said.
https://nypost.com/2020/05/01/new-york-conducting-coronavirus-tests-at-grocery-stores/

COVID-19 outpatient visits fall for 2nd week: 4 CDC findings

The amount of COVID-19 related visits to outpatient facilities and emergency departments decreased nationally in the week ending April 25, but still remained elevated in the Northeast and Northwest, according to the CDC’s weekly COVIDView report.
Four things to know:
1. The national percentage of respiratory specimens testing positive for SARS-CoV-2, the virus that causes COVID-19, decreased in public health and commercial laboratories, and remained stable in clinical labs. Nationwide, labs have confirmed 702,814 positive specimens since March 1.
2. The percentage of U.S. deaths attributed to flu, pneumonia or COVID-19 was 14.6 percent for the week ending April 25, down from 23.6 percent a week prior. This percentage still falls far above the epidemic threshold of 6.8 percent and may change as additional death certificates are processed, the CDC noted.
3. The cumulative hospitalization rate for all age groups increased to 40.4 hospitalizations per 100,000 population.
4. The amount of outpatient and emergency department visits for COVID-19 symptoms decreased and fell below baseline for the second consecutive week. While the decrease may be due to a drop in COVID-19 activity, it may also be fueled by less respiratory illness overall due to widespread social distancing efforts and changes in how people access healthcare.
https://www.beckershospitalreview.com/public-health/covid-19-outpatient-visits-fall-for-2nd-week-4-cdc-findings.html

Even as states reopen, many people stay put

At least 15 states are taking the first steps of reopening this weekend, but it will take awhile for customers and employees to venture out and return to pre-pandemic routines.
Traffic data for Charleston, SC, and Atlanta compiled by TomTom show that congestion levels haven’t changed much in the past few days since South Carolina and Georgia loosened restrictions and are well below mid-March levels, the Wall Street Journal reports.
And not all business owners are ready to reopen as they worry that easing the restrictions will lead to more COVID-19 cases.
Overall, Americans continue to be wary about venturing out. An Ipsos survey conducted April 16-19 found that two-thirds of respondents were nervous about leaving their homes even if businesses are open; 59% said businesses should remain closed until the coronavirus is fully contained.
Meanwhile, as the weather warms up in New York City, 1,000 police officers are being dispatched this weekend to enforce social distancing measures and other emergency rules to contain the virus.
https://seekingalpha.com/news/3567983-even-states-reopen-many-people-stay-put

Hospitals pledge new patient safety measures after coronavirus crush

U.S. hospitals, many past the peak coronavirus crush, are relying on plexiglass dividers, advance testing of patients and limited elevator traffic to convince people, especially those needing urgent care, that the facilities are safe.
Hospitals put lucrative elective procedures and other nonessential operations on hold weeks ago as they geared up for the coronavirus onslaught.
But fear of the highly contagious virus, which has killed over 63,000 people and infected more than one million in the United States, has kept even victims of serious health crises like stroke and appendicitis away from emergency rooms.
“We have to convey to the public that we are safe … and to defer medical care in urgent situations will cause more harm,” said Mark Solazzo, chief operating officer at Northwell Health, New York’s largest healthcare provider.
In addition to urgent care, medical providers are beginning to tell patients they can come back for more routine care, and are spelling out new precautions they are taking in order to regain the public’s trust.
Efforts put in place due to the pandemic – like screening people for symptoms of COVID-19 – the illness caused by the coronavirus – taking the temperature of everyone entering a healthcare facility, making people wear masks, and supplying disinfectant wipes, will continue.
Hospitals will still rely heavily on “telemedicine” visits by video chat to help triage patients and determine whether they need to be seen. Patients are automatically tested for coronavirus infection before they are admitted for scheduled surgery or other inpatient procedures. Northwell and other hospital systems have launched marketing campaigns to explain how they are making visits safer.
In an email sent to nearly 3 million New York area residents, Northwell reminds patients that visitors are not allowed at its hospitals, that all staff wear full protective gear, and that patients can wait in the parking lot and check in to appointments on their phone to avoid waiting room crowds. Plexiglass barriers are being used in reception areas to separate patients from office staff and the health system plans to share information about how facilities are being deep-cleaned.
UCHealth, Colorado’s largest health system, is limiting elevator capacity, normally around a dozen people, to four at a time, and is asking them to maintain their distance, with one person in each corner. To avoid sharing pens, UCHealth urges patients to fill out their paperwork online ahead of a visit.

RISK OF DELAYED CARE

U.S. hospitalization rates fell in March compared to February for a range of critical conditions, according to claims statistics from health insurer Cigna Corp.
Downturns ranged from 11% for acute coronary syndromes such as heart attack, to over 30% for patients experiencing stroke or irregular heartbeat. For a stroke, getting to the hospital very quickly is critical to recovery chances.
U.S. medical tests for detecting and monitoring cancer and other conditions fell by as much as 68% in mid-March through mid-April, according to a report from Komodo Health.
Several recent stroke patients at Hoag Hospital in Newport Beach, California had delayed care for days after their first symptoms, citing fear of the virus, Dr. Michael Brant-Zawadzki, the hospital’s senior physician executive, told Reuters.
One young man experienced weakness due to a rare lesion in his brain, but did not come to the hospital until he was paralyzed on one side. In another case, an elderly man had an acute stroke, but put off going to the hospital because he is in a high risk category for contracting the coronavirus. Both patients now have brain damage.
Cedars-Sinai Medical Center in Los Angeles is emailing patients to assure them that people diagnosed with COVID-19 are kept separate from the general hospital population, that staff members are screened daily and that everyone is required to wear face masks.
“We are encouraging people to seek urgent care. We still have the capacity,” said Dr. Richard Riggs, chief medical officer at Cedars-Sinai.
Hospitals are redesigning waiting rooms to space out seating, which in some cases is being replaced with furniture made of easy-to-clean materials.
“It is important that we don’t see ongoing delay of care. We worry about the escalation of chronic disease,” Dr. Robert Hart, chief medical officer at Ochsner Health, Louisiana’s largest hospital system, said in a phone briefing.
Ochsner is determining how to reschedule surgeries put on hold during the crisis in order to avoid “doing more harm than good,” he said.
https://www.reuters.com/article/us-health-coronavirus-usa-hospitals/u-s-hospitals-promise-new-safety-measures-to-ease-patient-fears-after-coronavirus-crush-idUSKBN22E0EP

India orders coronavirus tracing app for all workers

India has ordered all public and private sector employees use a government-backed contact tracing app and maintain social distancing in offices as it begins easing some of its lockdown measures in districts less affected by the coronavirus.
Prime Minister Narendra Modi’s government said on Friday India, with the world’s second-largest population after China, would extend nationwide curbs for another two weeks from Monday, but allow “considerable relaxations” in lower-risk areas.
India last month launched the Aarogya Setu (Health Bridge) app, a Bluetooth and GPS-based system that alerts users who may have come in contact with people who later test positive for COVID-19.
“Use of Aarogya Setu shall be made mandatory for all employees, both private and public,” the Ministry of Home Affairs said late on Friday.
Company heads will be held responsible “to ensure 100% coverage” among employees.
Officials at the technology ministry and a lawyer who framed the privacy policy for Aarogya Setu told Reuters the app needed to be on at least 200 million phones for it to be effective in a population of 1.3 billion.
The app has been downloaded around 83 million times in total in a country with a smartphone user base of about 500 million, according to the technology ministry.
The app’s compulsory use is raising concerns among privacy advocates, who say it is unclear how the data will be used and who stress that India lacks privacy laws to govern the app.
“Such a move should be backed by a dedicated law which provides strong data protection cover and is under the oversight of an independent body,” said Udbhav Tiwari, Public Policy Advisor for internet browser company Mozilla.
New Delhi has said the app will not infringe on privacy as all data is collected anonymously.
The app can help authorities identify virus hotspots and better target health efforts, the tech ministry told Reuters in late April, adding information would be used “only for administering necessary medical interventions”.
Critics also note that about 400 million of India’s population do not possess smartphones and would not be covered.
The government on Friday said that re-opening offices would also have to ensure gaps between shifts and staggered lunch breaks to contain spread of the coronavirus that has infected 3.3 million worldwide and caused more than 230,000 deaths.
India has reported more than 37,000 cases and 1,218 deaths.
India is set to allow some factories to re-open and companies are scrambling to piece together their plans.
Smartphone maker Lava is likely to open its plants in Noida, on the outskirts of New Delhi, next week, said co-founder S.N. Rai.
Lava is asking its workers to temporarily move to a neighbouring village, where it has leased dormitories for about 800 workers and is proving food and transport, said Rai.
“But even if we start production immediately, we will start with a maximum of 40% capacity,” said Rai.

Other sectors such as the automobile industry are calling on the government to allow them to re-open.
The automotive sector is losing revenue of 23 billion rupees ($304 million) a day, three lobby groups said in a letter to the home ministry, urging the government to allow component makers and dealers to begin operations.
https://www.reuters.com/article/us-health-coronavirus-india-app/india-orders-coronavirus-tracing-app-for-all-workers-idUSKBN22E07K?il=0

SCWorx discloses cancelation of 52M-unit COVID-19 test order

In a regulatory filing, SCWorx (NASDAQ:WORX) discloses that virtual healthcare network Rethink My Healthcare has canceled its purchase order for up to 52M COVID-19 rapid antibody tests announced on April 13.
The company says the reason for the cancelation was the inability of test supplier Brisbane, Australia-based ProMedical Equipment Pty Ltd. to fulfill its obligations to secure FDA approval to permit commercialization. SCWorx subsequently canceled its order with ProMedical.
On April 29, it entered into another supply agreement with Feltwell Holding SA, a wholesale trading company in the energy business, under which it agreed to purchase and Feltwell agreed to supply 500K COVID-19 rapid antibody tests, 100K to be shipped no later than May 4 and 400K within 15 days of order placement, expected to be no later than May 4. SCWorx agreed to pay 50% of the total order cost at the time of order placement and the remaining 50% upon completion of production (product ready for shipment). The first half has been paid by a third party under the condition that the third party will receive 25% of SCWorks’ gross profit on the first 100K units (and after it receives payment). The remaining balance on the first 100K units will be paid upon the completion of production of the total order.
Feltwell had an agreement with Carlsbad, CA-based Syntron Bioresearch to supply the tests, but it apparently fell through (Syntron makes rapid tests for pregnancy, allergy, glucose and others, including microwell tests for a range of infectious disease antibodies, but not COVID-19 yet). SCWorx states that it expects to receive “equivalent product” from another source.
The company is currently negotiating with potential customers for the tests, adding that there are no assurances that any agreements will be consummated. If not, then it will be unable to fulfill its obligations under the supply agreement.
Shares remain halted per an SEC order on April 22.
https://seekingalpha.com/news/3567979-scworx-discloses-cancelation-of-52m-unit-covidminus-19-test-order