FDA Warns Against Fraudulent COVID-19 Tests and Treatments
In the past few weeks, the number of coronavirus (COVID-19) incidents has sky-rocketed in the U.S. with the epicenter seemingly in New York. Companies have been stepping up to the plate to get approvals and authorizations for tests and vaccines to combat the pandemic.
This demand has also opened up the door for many companies to try and push fraudulent products onto the market with claims of treating or detecting COVID-19. FDA said it is cracking down on these fraudulent products.
In a release, the agency said it has also “seen unauthorized fraudulent test kits for COVID-19 being sold online.â€...
Source: MDDI - March 25, 2020 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Source Type: news
How Is COVID-19 Impacting Organ Transplants?
When asked how the coronavirus (COVID-19) pandemic is impacting patients in need of an organ transplant, Sridhar Tayur said there is good news and bad news on that front. Tayur is the Ford distinguished research chair and professor of operations management at Carnegie Mellon University’s Tepper School of Business, and he has been paying close attention to the subject of organ transplants during the current crisis.Â
"The good news is that transplants are considered critical surgeries and therefore CMS [Centers for Medicare and Medicaid Services]Â h...
Source: MDDI - March 25, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Astrotech Developing New Test for COVID-19
A new test being developed by Austin, TX-based Astrotech could detect coronavirus (COVID-19) and other lung diseases from the metabolites found in a person’s breath.
The company’s BreathTest-1000 is a mass spectrometry technology that was initially developed in collaboration with the National Aeronautics and Space Administration (NASA), the U.S. Army, and the Transportation Security Administration (TSA).
Astrotech’s testing technology was designed to be inexpensive, small, rugged, fast, and easy to use for air quality monitoring and trace detection of chemical warfare a...
Source: MDDI - March 25, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news
How 3D Printing Is Helping in the Fight Against Coronavirus
3D printing companies like Prusa3D are calling on the wider community to help with printing essential medical devices like face shields. (Image source: Prusa3d)
As hospitals and other medical facilities all over the world are experiencing a shortage of masks, shields, and other equipment in the wake of the COVID-19 outbreak – the 3D printing community, from makers and hobbyists to major companies, are answering the call.
“Ok 3D Printers [sic], if ever there was a moment for us its [sic] now. I received no less than 50 texts last night directly from local ER docs BEGGING for as many shiel...
Source: MDDI - March 25, 2020 Category: Medical Devices Tags: Design News Source Type: news
Virtual Medical Device Meetings You Need to Know About
3D-printing company hosts virtual roundtable Wednesday
Nanofabrica, a Tel Aviv, Israel-based manufacturer of 3D printers for precision engineering, will host a virtual roundtable for researchers, doctors, and manufacturers to harness the companies manufacturing capabilities to develop medical devices and solutions related to the coronavirus (COVID-19) pandemic. The roundtable is scheduled for 4 p.m. GMT+2 (10 a.m. Eastern Time) Wednesday via Zoom. Professionals unable to join the virtual session are invited to email relevant questions and details to tovit@nano-fabrica.com. Click here for the meeting link.
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Source: MDDI - March 25, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business 3-D Printing Source Type: news
How CDRH Is Responding to COVID-19
FDA issued a letter to industry that includes steps the agency's Center for Devices and Radiological Health (CDRH) has taken to prioritize work that advances the nation’s response during the Coronavirus (COVID-19) public health emergency.
The agency said these steps seek to address the impact of COVID-19 on day-to-day operations in CDRH and in the medical device industry, while ensuring that government and private sector efforts to respond to the emergency receive the highest priority.
CDRH has converted in-person meetings with industry to teleconferences fo...
Source: MDDI - March 24, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance IVD Source Type: news
Conformis Faced with Tough Decision to Furlough One-Third of Its Workforce
Conformis is furloughing one-third of its workforce citing a sharp decline in elective procedures because of the novel coronavirus (COVID-19). In addition to the measure, the custom orthopedics implant company said it us withdrawing its 3% to 6% product revenue growth target for 2020.
The Billerica, MA-based company said its product areas of knee and hip surgery are being impacted in ‘unprecedented ways.’ About 80 employees would be furloughed.
“We’ve taken a very aggressive early action here with [Monday’s] announcement,â€...
Source: MDDI - March 24, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Orthopedics Source Type: news
FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices
In an effort to ease remote patient monitoring during the COVID-19 pandemic, FDA has issued the temporary guidance, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.†This guidance is effective immediately, without prior industry or public comment, and it will remain in effect during the duration of the public health emergency.
As part of the enforcement policy, FDA does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of no...
Source: MDDI - March 24, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news
Masimo ’s Latest Acquisition Could Help in the Fight Against COVID-19
Masimo’s new acquisition could aid in the fight to help manage coronavirus (COVID-19) patients. The Irvine, CA-based company said late last week that it had entered into a definitive agreement to acquire ventilation company specialist, TNI medical AG for an undisclosed sum.
The deal is set to close in 2Q20 and Masimo expects to fund the acquisition with existing cash on hand and expects the transaction to have an immaterial impact to net earnings in 2020.
Würzburg, Germany-based TNI has designed the softFlow technology to provide high flow, warmed, and humidified respiratory gases to sponta...
Source: MDDI - March 24, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
FDA Issues Enforcement Policy for Ventilators Amid Shortage Concerns
Ventilator shortages dominated the coronavirus-related news cycle over the weekend with Elon Musk revealing ventilator discussions with Medtronic, and FDA implementing an enforcement policy for ventilators and accessories, along with other respiratory devices. The policy went into effect immediately and will remain in effect for the duration of the coronavirus (COVID-19) public health emergency.
"Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate," the ...
Source: MDDI - March 23, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Elon Musk Talks Ventilators with Medtronic
Some call him a genius, others call him a conman with a questionable track record, but regardless of your opinion of Elon Musk, one thing is for sure: If Musk wants to talk ventilators, Medtronic will listen.
Tweets from Musk and Medtronic triggered a heated debate over the weekend about how the world's largest public medical device company might be able to work across industries to solve problems associated with the coronavirus (COVID-19)Â pandemic.
"Just had a long engineering discussion with Medtronic about state-of-the-art ventilators. Very impressive team," Musk tweeted on Saturday.
Medtronic ac...
Source: MDDI - March 22, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Virginia Boy 3D Prints Mask for Sick Uncle and Others
At a time when people all across the globe are frightened and dismayed, it is uplifting to see kindness and compassion trending. And on Twitter, of all places.
Renee Randolph, a culinary arts and sciences instructor in Arlington, VA, is going viral on Twitter this weekend after she tweeted about her son using a 3D printer to make a face mask for his high-risk uncle who is at home waiting for a heart transplant. Best of all, he is printing more masks to donate. Randolph's tweet had been liked by nearly 25,000 people and about 4,000 people had retweeted it as of Saturday afternoon.
Scree...
Source: MDDI - March 22, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: 3-D Printing Source Type: news
U.S. Government Issues RFI for Solutions to Combat Coronavirus (COVID-19)
To counter the coronavirus (COVID-19) pandemic, the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) has directed the Medical CBRN Defense Consortium (MCDC) to issue a request for information (RFI) for solutions involving diagnostics/monitoring, surveillance and screening devices, information systems, point-of-care devices, therapeutics, prophylactics, and clinical trials. The submitted solutions will be considered for federally funded research and development projects, the MCDC reported.
The MCDC was formed to support the Department of Defense’s (DoD...
Source: MDDI - March 21, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Regulatory and Compliance Source Type: news
Medtech in a Minute: Axonics Contests Medtronic Patents, COVID-19 Rages on, and More
Fears of ventilator shortages prompts swift FDA action
On Sunday, FDA issued an immediately-in-effect policy intended to help increase availability of ventilators and their accessories as well as other respiratory devices during the COVID-19 pandemic. The guidance, issued without a public comment period, is intended to foster the continued availability of the devices while being flexible regarding manufacturer modifications made to ventilators, anesthesia gas machines, and other respiratory devices, and their accessories, in response to the COVID-19 public health emergency.
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New tests, production i...
Source: MDDI - March 20, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Test Shows How Lung Cancer Patients Respond to Therapy
Oncocyte said it has completed Clinical Laboratory Improvements Amendments (CLIA) validation for its DetermaIO. The Irvine, CA-based company said the diagnostic, which was previously known as the Insight Genetics IM Score Test, is used in lung cancer patients to identify individuals more or less likely to respond to anti-PD-1/PD-LI immunotherapy.
Oncocyte said the DetermaIO test differentiates itself from the current leading immunotherapy diagnostic tests by having the capability to determine if the immune microenvironment is active (“hotâ€) or quiescent (“coldâ...
Source: MDDI - March 20, 2020 Category: Medical Devices Authors: Omar Ford Tags: IVD Regulatory and Compliance Source Type: news
