Thermoformer Develops Face Shields Needed in COVID-19 Pandemic
Prent Corp., a thermoformer of custom plastic medical device packaging, has designed a new face shield for healthcare workers and dedicated a new line to producing the shields, in just 48 hours. As of March 30, the company had produced and donated more than 20,000 shields to Mercyhealth Hospital and Trauma Center and other local healthcare facilities, Joseph Pregont II, vice president of corporate sales at Prent, told MD+DI. The company is planning to ramp up production to offer face shields to healthcare workers throughout the United States.
“We heard there was a dire need in our community and we knew we...
Source: MDDI - March 31, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Packaging Source Type: news
Medtronic Shares Ventilator Design Amid Shortage Concerns
Medtronic has already ramped up production of its high-performance Puritan Bennett 980 ventilators by more than 40%, and is on track to more than double its capacity to manufacture and supply the ventilators in response to the coronavirus (COVID-19) pandemic. But even at a production volume of 500 machines a week, the Dublin, Ireland-based company recognizes the need for more.
The company is now publicly sharing the design specifications for an older model of the technology, the Puritan Bennett 560 (PB 560), which will allow companies across industries to evaluate options for rapid ventilator manufacturing to a...
Source: MDDI - March 31, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
New York Times Article on Failed Ventilator Program Triggers a Response from Medtronic
A New York Times article about a failed attempt to boost the U.S. ventilator stockpile several years ago lacks important information, according to Medtronic.
The article, "The U.S. Tried to Build a New Fleet of Ventilators. The Mission Failed,"Â provides a deep dive into a contract between the federal government and a company known at the time as Newport Medical. That company was acquired by Covidien, which in turn was acquired by Medtronic in 2015.
Medtronic issued a statement Sunday in response to the article, which outlines the company's "understanding of the facts" regarding theÂ...
Source: MDDI - March 30, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Quarantined Physician Waiting on COVID-19 Test Results for Nearly 2 Weeks
 Nefertiti Brown, MD's life is on pause right now. The 39-year-old physician is quarantined in her home, awaiting results from a COVID-19 test she took nearly two weeks ago. Dr. Brown, a graduate of the University of Pittsburgh School of Medicine, is an attending physician in the Bay area. Dr. Brown spoke with MD+DI on Saturday about her experience and how she hopes it can make an impact on others.
“Shortly after daylight savings time, I noticed that I was feeling tired,†the New York native recounted. “But I’m always tired. Iâ€&...
Source: MDDI - March 30, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news
Formlabs Is 3D Printing More than 100,000 COVID-19 Test Swabs Daily
3D printer company Formlabs reports that it is now using its 250+ in-house 3D printers at its Ohio-based printing facility to produce up to 150,000 COVID-19 test swabs per day. The swabs are being used on patients at hospitals and healthcare providers across the country experiencing test kit shortages, including New York’s largest hospital system, Northwell Health, and Tampa General Hospital.
Over the span of one weekend, Formlabs, Northwell Health, and University of South Florida (USF) Health worked together to develop and test a nasal swab prototype, said Formlabs. In just two days, USF Health and North...
Source: MDDI - March 29, 2020 Category: Medical Devices Tags: PlasticsToday Source Type: news
COVID-19 News Central
Medical device companies play an essential role in combatting the novel coronavirus (COVID-19). To help, MD+DI is tracking developments in evolving regulator policies, support from medtech suppliers, and the progress being made in meeting urgent needs for medical supplies. Click on the links below for details, and monitor this page for updates.
Regulations, Policies, and Government ResponseHow CDRH Is Responding to COVID-19Proposal to Postpone EU Medical Device Regulation UnderwayFDA Warns Against Fraudulent COVID-19 Tests and TreatmentsFDA Issues Emergency Guidance for Non-Invasive Remote Monitoring DevicesFDA Issues Enfo...
Source: MDDI - March 29, 2020 Category: Medical Devices Authors: MD+DI Staff Tags: Business Source Type: news
Medtech in a Minute: COVID-19 Impacts Business, Regulation, and More
EC pushes to postpone new medical device regulationsÂ
As the deadline for the new medical device regulations to go into force in the European Union rapidly approaches (end of May), the European Commission (EC)Â is looking to postpone the new regulations by one year. The delay would allow national authorities and industry to focus on urgen priorities related to the coronavirus (COVID-19) crisis, said a spokesman for the EC.
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Elon Musk Talks Ventilators with Medtronic
Tweets from Elon Musk and Medtronic attracted a lot of positive and negative attention. Musk said he "had a long engineerin...
Source: MDDI - March 28, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Apple Jumps into COVID-19 Fight with New Screening Tool
Apple has released a new online screening tool that could help in the battle against COVID-19. The Cupertino, CA-based company worked on the COVID-19 website and COVID-19 app in partnership with the Centers for Disease Prevention and Control, the White House Coronavirus Task Force and FEMA.
In a release, the company said the COVID-19 app and website allow users to answer a series of questions around risk factors, recent exposure, and symptoms for themselves or a loved one. In turn, they will receive CDC recommendations on the next steps, including guidance on social distancing and self-isolating, how to closely monitor sym...
Source: MDDI - March 27, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news
A Comprehensive Guide to COVID-19 EUA Submissions
Links for additional information:
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
Additional frequently asked questions about COVID-19 EUAs, including questions specific to clinical laboratories and questions specific to test kit manufacturers
If you have additional questions for FDA contact the Division of Microbiology Devices at 301-348-1778 or email CDRH-EUA-Templates@fda.hhs.gov (Source: MDDI)
Source: MDDI - March 27, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance IVD Source Type: news
Obalon Mulling Over Strategic Options Amid COVID-19 Crisis
Obalon Therapeutics is exploring financial and strategic alternatives because of the impact of COVID-19 on elective procedures. The weight loss solutions company said on Wednesday that these alternatives could include equity or debt financing; a sale of the company; a business combination; or a merger or a reverse merger with another party.
Obalon has developed a gas-filled intragastric balloon system that treats obesity. The device won a nod from FDA back in 2016.
The company has engaged Canaccord Genuity as its advisor. Â
Nearly a year ago, Obalon made a similar play, albei...
Source: MDDI - March 27, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Implants Source Type: news
Early-Warning System for Detecting Infections Is Being Studied
Most of the early physiological and biochemical changes that could be an indication of an infection in a patient’s body are asymptomatic, said Ben Hwang, chairman and CEO of Profusa, in an interview with MD+DI. “People don't see or feel [them],†he said, noting that it could be weeks before patients present with symptoms such as a fever or cough. But in the meantime, as we have seen with the COVID-19 pandemic, asymptomatic people could be spreading diseases unknowingly.
“What will be helpful is to be able to identify individuals at the presymptomatic s...
Source: MDDI - March 26, 2020 Category: Medical Devices Authors: Susan Shepard Tags: Implants Source Type: news
Supplier Stories for the Week of March 22
(Source: MDDI)
Source: MDDI - March 26, 2020 Category: Medical Devices Authors: Daphne Allen Tags: IVD Source Type: news
Thermo Fisher Granted CE Mark for COVID-19 Test
Thermo Fisher Scientific is bringing its diagnostic detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19, to Europe. The Waltham, MA-based company said earlier today it had received CE mark for the test.
The test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis.
"The CE mark certification is an important step in combatting the outbreak of COVID-19 across Europe," said Marc Casper, chairman, president and CEO of Thermo...
Source: MDDI - March 26, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Regulatory and Compliance Source Type: news
Proposal to Postpone EU Medical Device Regulation Underway
The European Commission is working on a proposal to postpone “the entry into force of the new medical device regulations for one year,†Stefan De Keersmaecker, a spokesperson for European Commission, explained during this video shared by the commission. The proposal is expected to be submitted in early April.
“We call on parliament and on council to adopt it quickly, as the deadline for entry into force is at the end of May,†De Keersmaecker said.
This delay would relieve pressure "from national authorities and industry and allow them to focus on urgen...
Source: MDDI - March 26, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news
Graphite-embedded plastic kills 99.99% of bacteria on contact
Plastic surfaces embedded with graphite nanoplatelets reportedly can prevent hospital-acquired infections (HAIs), killing 99.99% of bacteria that try to attach, according to research from Chalmers University of Technology in Sweden.
Human cells are around 25 times larger than bacteria (pictured here in green). While the graphite nanoplatelets slash and kill bacteria, they barely scratch a human cell. Image courtesy Chalmers University of Technology.
​At any given time, 7% of hospital patients in developed countries and 10% in developing economies will contract at least one HAI, according to the World Hea...
Source: MDDI - March 25, 2020 Category: Medical Devices Tags: Design News Source Type: news
