HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process.
In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance.
Get the full story on our sister site, Medical Design & Outsourcing.
PhysIQ announced today that the National Institutes of Health (NIH) entered into Phase II of a contract for its AI-based COVID-19 biomarker.
A Purdue University-affiliated artificial intelligence company, PhysIQ’s AI-based COVID-19 digital biomarker is being developed to address the rapid decompensation of high-risk COVID-19 patients, according to a news release.
PhysIQ’s technology’s cloud platform continuously collects and processes data from any wearable biosensor. In this case, the platform seeks out biomarkers to determine if a person infected with COVID-19 is experiencing a worsening in their condition.
Instead of using measurements such as temperature and pulse oximetry, PhysIQ’s platform offers multi-parameter vital signs and physiological features which establish a targeted biomarker (COVID-19 Decompensation Index — CDI) for worsening coronavirus-caused condition.
The contract option, exercised by the National Canc…
After three consecutive weeks of record-breaking numbers, medtech industry stocks finally fell backward over the past seven days.
MassDevice‘s MedTech 100 index finished last week at 105.8 (Jan. 15), marking a -0.95% drop from the 106.81 points (the highest ever total for the index) registered at the end of the week prior (Jan. 8). Medtech’s stock performance appeared to mirror overall markets as the S&P 500 Index saw a -1.5% loss, while the Dow Jones Industrial Average fared almost identically to medtech, falling by -0.91%.
The index still remains more than 13 points ahead of its pre-pandemic high of 92.32 on Feb. 19, 2020. Medtech’s lowest point during the COVID-19 pandemic remains at 62.13 on March 23. Since then, the industry’s stocks have experienced 70.3% growth in total, as of the end of last week. (Here are some of the best-performing medtech stocks from 2020.)
The industry continues to plug along and businesses continue to operate thro…
Pfizer-BioNTech vaccine image courtesy of Wikipedia
Last week, President-elect Joe Biden vowed to release COVID-19 vaccine doses from a government stockpile.
On Jan. 13, the U.S. Department of Health and Human Services (HHS) echoed that sentiment, stating it would “no longer stockpile millions of COVID-19 vaccine doses held to ensure Americans receive their second shot,” according to a brief notice.
But federal officials had already drained vaccine reserves before the HHS vowed to open up a vaccine stockpile, according to state officials who had been expecting more doses.
Local government officials expecting vaccine supplies to roughly double starting next week are now forced to contend with the status quo.
Critics of Operation Warp Speed, a public-private partnership established by the Trump administration to support COVID-19 vaccine distribution, have been frustrated with the speed …
Dr. David Kessler, former FDA commissioner and incoming chief scientific officer of the Biden administration’s COVID-19 response [Photo by Justin Hoch, CC BY 2.0]
President-elect Joe Biden today announced that Dr. David Kessler, who led FDA through much of the 1990s, will serve as chief science officer of his administration’s COVID-19 response.Kessler’s achievements at FDA included speeding the approval of drugs to reduce the AIDS death toll. He’ll now be helping to lead efforts to speed authorization and delivery of vaccines to bring the COVID-19 pandemic under control — as well as an overall, comprehensive, whole-of-government COVID-19 response.
“We are in a race against time, and we need a comprehensive strategy to quickly contain this virus,” Biden said in announcing the appointment of Kessler and other new members of the COVID-19 response team.
Kessler has alr…
Kessler’s achievements at FDA included speeding the approval of drugs to reduce the AIDS death toll. He’ll now be helping to lead efforts to speed authorization and delivery of vaccines to bring the COVID-19 pandemic under control — as well as an overall, comprehensive, whole-of-government COVID-19 response.
Get the full story on our sister site Pharmaceutical Processing World.
Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines.
To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna(NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).
We reached out to Dr. Whitney Bowe, a board-certified dermatologist and expert injector, to shed light on the topic.
Get the full story form our sister site, Drug Discovery & Development.
While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward.
Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while pivoting to artificial-intelligence-based and remote care.
Companies like Moderna arose from nowhere, climbing from a share price of $19.52 to $104.47 over the course of the year as it established itself as a frontronner in the race to get a COVID-19 vaccine to the public, eventually becoming the second vaccine authorized in the U.S.
MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has hit new heights over the course of 2020, indicating the upward trajectory of the industry. Over the course of the year, the index grew from a total of $86.8…
(From Ishant Mishra on Unsplash)
While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward.
Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while pivoting to artificial-intelligence-based and remote care.
Companies like Moderna arose from nowhere, climbing from a share price of $19.52 to $104.47 over the course of the year as it established itself as a frontronner in the race to get a COVID-19 vaccine to the public, eventually becoming the second vaccine authorized in the U.S.
MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has hit new heights over the course of 2020, indicating the upward trajectory of the industry. Ove…
In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).
To date, it has analyzed data from 13 of those individuals.
The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly and frail patients.
Get the full story from our sister site, Drug Discovery & Development.
Image from Mark König on Unsplash
In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).
To date, it has analyzed data from 13 of those individuals.
The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly and frail patients.
The agency said in a statement that it had expected deaths close to the time of vaccination, given its plan to vaccinate elderly patients, many of whom have “serious underlying diseases.” Some 400 people in Norway die each week in nursing homes and long-term care facilities.
While it is clear that elderly individuals have a higher risk of mortality from all causes, it will take time to determine what role a vaccine might play, said Updesh Dosanjh, practice le…
[Joe Biden photo from Wikipedia]
President-elect Joe Biden has announced a proposal for a $1.9 trillion economic rescue package that includes $415 billion to fight the pandemic, including boosting COVID-19 vaccine deployment. Of that latter total, some $20 billion would be invested in a national vaccination program to establish community vaccination centers across the country, including mobile vaccination units in rural areas. Another $30 billion would cover supplies and personal protective equipment.The possibility of a Senate trial in Biden’s first 100 days in office could be a roadblock for the plan.
Nevertheless, Biden aims to have 100 million COVID-19 vaccine doses administered in his first 100 days in office.
Biden’s plan also earmarks $50 billion for COVID-19 testing and would strengthen the nation’s use of genomic testing to track SARS-CoV-2 mutations.
To date, there have bee…