FDA Archives - Page 87 of 103 - Medical Design Sourcing

FDA issues EUA for Thermo Fisher Scientific COVID-19, flu combo test

Thermo Fisher Scientific (NYSE:TMO) announced today that it received FDA emergency use authorization (EUA) for a COVID-19/flu combo test.

Carlsbad, Calif.-based Thermo Fisher’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B combo kit is a real-time PCR test for detecting and differentiating RNA from SARS-CoV-2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs, according to a news release.

The company’s kit includes Applied Biosystems pathogen-interpretive software for converting genetic analysis data into a readable report automatically to reduce the risk of errors with interpretation, Thermo Fisher said.

Testing with the TaqPath COVID-19, Flu A, Flu B combo kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests, or by similarly qualified non-U.S. laboratories.

“Understanding that the flu season would ov…

Visby Medical wins FDA authorization for point-of-care COVID-19 PCR test

Visby Medical announced today that it received FDA emergency use authorization (EUA) for its rapid COVID-19 test at point-of-care.

San Jose, Calif.-based Visby’s rapid PCR COVID-19 test received EUA previously but can now be used by any organization with a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, according to a news release.

Visby’s testing device has palm-sized dimensions and eliminates the need for an additional instrument or reader so that it can provide fast, accurate results at the point of care, requiring only a power plug. Additionally, Visby said it has the potential capability to run pooled tests in the future.

“This latest authorization will have a significant impact on COVID-19 testing, especially in situations when an accurate result is needed quickly,” Visby chief medical officer Dr. Gary Schoolnik said in the release. “Visby’s test can now be used directly at the point of …

Looking back at two decades of CGM advances

The Freestyle Libre 2 from Abbott

Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history.

Attempts to manage glucose kicked off in earnest when researchers began measuring glucose in urine in the mid-1800s. Scientists’ ability to do so steadily improved over the years, but urine glucose testing wasn’t commercialized until 1908, establishing a foundation for diabetes care.

Elkhart, Ind.-based Ames Company refined the process in 1945 with the introduction of Clinitest reagent tablets, which are still commercially available, albeit from Bayer (ETR:BAYN). The company would introduce the first blood glucose test strip in 1965. The Dextrostix-branded strips were intended for use in doctors’ offices.

Get the full story on our sister site, Drug Delivery Business News.

Looking back at two decades of CGM advances

FreeStyle Libre 2 from Abbott

Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history.

Attempts to manage glucose kicked off in earnest when researchers began measuring glucose in urine in the mid-1800s. Scientists’ ability to do so steadily improved over the years, but urine glucose testing wasn’t commercialized until 1908, establishing a foundation for diabetes care.

Elkhart, Ind.-based Ames Company refined the process in 1945 with the introduction of Clinitest reagent tablets, which are still commercially available, albeit from Bayer (ETR: BAYN). The company would introduce the first blood glucose test strip in 1965. The Dextrostix-branded strips were intended for use in doctors’ offices.

In the 1970s, Ames developed a device known as the Ames Reflectance Meter to measure reflected light from a Dextrostix strip. It was the first blood glucose mete…

FDA authorizes Eli Lilly’s monoclonal antibody treatment for COVID-19

The FDA announced that it issued emergency use authorization (EUA) for monoclonal antibodies developed by Eli Lilly (NYSE:LLY) for treating COVID-19.

Eli Lilly’s bamlanivimab and etesevimab received authorization to be administered together for treating mild to moderate COVID-19 in adults and pediatric patients over 12 years old and weighing at least 40 kilograms (about 88 pounds), according to a news release. Bamlanivimab had already received an EUA in November 2020 for treating mild-to-moderate COVID-19 cases.

Get the full story at our sister site, Drug Discovery & Development.

FDA authorizes Eli Lilly’s monoclonal antibody treatment for COVID-19

The FDA announced that it issued emergency use authorization (EUA) for monoclonal antibodies developed by Eli Lilly (NYSE:LLY) for treating COVID-19.

Eli Lilly’s bamlanivimab and etesevimab received authorization to be administered together for treating mild to moderate COVID-19 in adults and pediatric patients over 12 years old and weighing at least 40 kilograms (about 88 pounds), according to a news release. Bamlanivimab had already received an EUA in November 2020 for treating mild-to-moderate COVID-19 cases.

Authorization for the antibody treatments is for those who test positive for SARS-CoV-2 and are at high risk for progressing to severe COVID-19. The authorized use includes treating those who are 65 years of age or older who have certain chronic medical conditions. Authorization does not include patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19, as the antibodies may be associated with worse clinical outcomes …

FDA recommends limiting use of ventilator splitters for COVID patients

The early-pandemic ventilator shortage prompted researchers to design ventilator splitters like this one. (Image courtesy of Johns Hopkins University)

The FDA is urging healthcare providers to use ventilator splitters for COVID-19 patients only when there is no alternative.

The agency released a letter to providers asking them to consider non-invasive ventilation such as high-flow nasal oxygen or non-invasive positive pressure ventilation before resorting to a ventilator splitter. If a ventilator splitter is the only option, the agency said clinicians should limit sharing of ventilation to two patients with similar ventilatory requirements and only for up to 48 hours.

The recommendations are based on clinicians’ experience and research conducted since the pandemic began. “These activities greatly increased the understanding of the known and potential risks and benefits of ventilator splitters in a very short time,” the agency said.

Get the full story on …

ProPhase Labs debuts single saliva test for COVID, flu

ProPhase Labs (NSDQ:PRPH) announced today that it is introducing a new saliva-based test for COVID-19, Influenza A, B and more.

Garden City, N.Y.-based ProPhase Labs said in a news release that it filed for FDA emergency use authorization for its two new testing methodologies, which integrate the Spectrum Solutions saliva self-collection system with a new multiplex qPCR platform for simultaneous RNA detection of SARS-CoV-2, COVID-19 viral mutations, Influenza A, B and more.

The SDNA Viral saliva-based testing combination offers pain-free self-collection, 100% in-device viral neutralization, the removal of the need for cold-chain storage of samples and overall consistency and accuracy, ProPhase Labs said.

Spectrum Solutions developed the first saliva-based COVID-19 test to garner FDA EUA in April, working in tandem with Accurate Diagnostics Labs and Rutgers University’s RUCDR.

“We are privileged t…

FDA authorizes marketing of device to boost tongue muscles and reduce sleep apnea

The FDA announced today that it authorized the marketing of a device for reducing snoring and mild obstructive sleep apnea.

The prescription-only device is used while awake to improve tongue muscle function, which can help prevent the tongue from collapsing backward and obstructing the airway during sleep. It is the first device of this kind used while awake, according to a news release.

Signifier Medical Technologies‘ ExciteOSA device delivers electrical muscle stimulation through a mouthpiece sitting around the tongue. The mouthpiece consists of four electrodes, two above and below the tongue, each. The device’s sessions consist of a series of electrical pulses with rest periods in between, as it is used for 20 minutes once per day during a wakeful state over a six-week period. Then, it is used once per week thereafter.

The FDA observed the ExciteOSA device in 115 patients with snoring, including 48 with snoring and mild sleep apnea. All pa…

Altaris ups investment in Minnetronix

Minnetronix Medical announced today that healthcare investment firm Altaris Capital Partners has acquired the majority share of the company.

Altaris, which actively manages $4.9 billion of equity capital, had been a minority investor in Minnetronix since 2015. The St. Paul, Minn.-based contract manufacturer declined to reveal the amount of the new investment.

“Throughout our relationship with Altaris, we have achieved many milestones as a company,” said Minnetronix CEO Jeremy Maniak in a news release. “Now, with our expanded partnership, we are excited to accelerate our strategy and move into the next stage of growth at Minnetronix.”

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FDA names first medtech cybersecurity chief

Kevin Fu (Image courtesy of University of Michigan)

University of Michigan computer science researcher Kevin Fu has been named acting director of medical device cybersecurity at the FDA.

Fu began working in the newly created 12-month post on Jan. 1, 2021, according to the university. His assignment is to bridge the gap between medicine and computer science and help manufacturers protect medical devices from digital security threats.

An associate professor of electrical engineering and computer science, Fu is the founder of the Archimedes Center for Medical Device Security. As an acting director, he’ll retain his university appointment.

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

FDA labels Boston Scientific ICD electrode recall serious

The EMBLEM S-ICD subcutaneous electrode with an arrow showing where separation usually happens (distal to the proximal sense ring) (Image courtesy of the FDA)

The FDA today declared the recall of a Boston Scientific subcutaneous electrode used in implantable cardioverter defibrillators (ICDs) as Class 1, the most serious.

The company warned physicians in December 2020 that approximately 47,000 Emblem S-ICD1 subcutaneous electrodes (model 3501) may fracture. Boston Scientific said at the time that it had received 27 reports of electrode body fractures at a location just distal to the proximal sense ring in devices distributed worldwide since 2017. One patient died, the company said.

Separately, the FDA reported there had been 26 reports of serious injuries and said its recall covers 19,919 units of the devices.

Such fractures may lead to “inappropriate shock therapy (IAS) in select programmed sense configurations,” the company said in December. If high-vo…