fbpx
Connect with us

MedTech

World Health Day: Advanced MedTech solutions on the worldwide radar

Published

 on

advanced MedTech solutions

Over the course of the past year, health has been nudged into the limelight due to the rampant spread of the COVID-19 pandemic, as it commanded the global news cycle on a daily basis.

But while the worldwide economy suffered, the ripple affect caused by the screeching halt of in-contact interactions, many looked at this period as a time of awakening for people to start actively focusing on their wellbeing.

With the eyes of the world on the health sector, accelerated ingenuity came within the field of medicine, specifically MedTech. Everything from funding, volunteers, and continental collaborations, were drawn up to fight the pandemic.

With COVID-19 spearheading the fight for accelerating MedTech, companies and researchers saw an opportunity to use the attention caused by the pandemic toward both the scientific advantage of medical technology and for the greater cause of helping humanity.

As such, on the occasion of World Health Day, here are some advanced MedTech solutions and initiatives that are picking up traction on the global radar.

AstraZeneca developing tech for heart failure, asthma

Biotechnology company AstraZeneca announced on Tuesday that its currently collaborating with Massachusetts General Hospital to create and clinically validate patient centric advanced MedTech solutions.

According to the company, the collaboration will use AstraZeneca’s new AMAZE disease management platform to study heart failure and asthma management. 

“We are incredibly proud to be working closely with Massachusetts General Hospital to utilize this digital platform to close gaps in patient care, ultimately leading to better outcomes,” Ruud Dobber, president of the BioPharmaceuticals Business Unit at AstraZeneca, said in a statement.

The biotechnology company notes that its AMAZE disease management platform uses remote monitoring to identify at-risk patients and deliver insights to the clinical care team at the point of care, all while reducing healthcare costs.

As per the details of the heart failure case study found on ClinicalTrials.gov, patients enter personal information using the AMAZE app, which will feed it into a clinician-facing dashboard embedded within their electronic health record. 

Patients will be enrolled in the study after an inpatient heart-failure admission at Massachusetts General Hospital. The organizations say the first two studies are aimed at piloting AMAZE in a real-world setting with the goal of improving patient engagement, care-team communication, and clinical outcomes. 

“We believe the AMAZE disease management platform has the potential to transform the current healthcare delivery paradigm for patients around the world living with chronic diseases,” said Dobber. 

Following both cases of heart failure and asthma, Massachusetts General and AstraZeneca highlight that they are on looking to expand the use of AMAZE across multiple chronic disease areas to patients throughout and beyond the Mass General Brigham system. 

“While there is no precedent for this type of deep relationship, we hope this alliance will serve as a model for future collaboration between pharma and healthcare providers,” said Dr. Peter L. Slavin, president of Massachusetts General Hospital. 

UK govt funds domestic MedTech and life science industries

The British government launched on Wednesday a multi-million-pound fund to support the MedTech and life sciences sectors, called the “Medicines and Diagnostics Manufacturing Transformation Fund,” which is designed to the country’s ability to prepare and respond to future pandemics.

“With two-thirds of life science manufacturing jobs already outside London and the South East, the new £20 million ($27.54 million) fund will also open up economic and investment opportunities for manufacturers across the whole of England, Northern Ireland, Scotland and Wales, improving our domestic supply chains and safeguarding and creating hundreds of highly skilled manufacturing jobs,” a government statement said.

The UK has one of the strongest and most productive health and life sciences industries globally, with a turnover of £80 billion and supporting 256,000 jobs, underpinned by a powerful research landscape and high-quality science base.

“This will not only boost the UK’s already strong vaccine and medicine portfolio but support top quality, local jobs across the country and put the UK in a formidable position to continue responding to the most pressing global challenges of our time,” Business Secretary Kwasi Kwarteng commented.

COVID-19 advanced MedTech solutions

UK-based healthcare company Medichecks launched a new antibody test to track unique responses to COVID-19 or the vaccine.  According to research conducted by the NHS, men reportedly produce higher antibodies levels in response to COVID-19.

Medichecks’ CE-marked finger-prick test can be taken at home and detects antibodies to the spike protein of SARS-CoV-2.

According to the company, results are available within two to three days and will identify a figure on a scale of 0.4 to 2500 (units per milliliter). A score of below 0.8 means no antibodies were detected; anything above this shows the presence of antibodies to the virus.

This will allow individuals to track and monitor their antibody levels, which would prove highly beneficial in terms of information on immune responses of different people; the company explained that the test can be done at three-to-four-month intervals, to measure variation.

“What is being learnt about COVID-19’s impact on the immune system is still a moving target, but this test lets people monitor their antibody levels over time. It is not yet known how long immunity, once it has developed, will fade, what level of antibodies provides immunity to coronavirus or at what level re-vaccination will be needed,” Dr. Sam Rodgers, chief medical officer at Medichecks, said in statement.

Manufactured by Roche, the Anti-SARS-CoV-2-S coronavirus antibody test is priced at £69.

Medichecks posts a sample collection kit to customers together with full instructions on how to collect a blood sample in a small vial at home. The sample is then posted to a UKAS accredited laboratory for analysis. The result, accompanied by a doctor’s interpretation, is uploaded to the customer’s online dashboard.

The rise of wearable MedTech

Wearable medical devices have been on the up and up for many around the world, as they take a more serious view within their own wellbeing; in parallel, the manufacturers and big tech companies have capitalized.

According to market research company Mordor Intelligence, the wearable medical devices market was valued at $19,450 million in 2020 and is expected to reach $47,837 million by 2026, registering a CAGR of about 16 percent over the forecast period.

Wearable devices play a crucial role in predicting certain disorders by integrating essential vital signs with clinical symptomology.

For instance, in 2020, researchers at Rockefeller Neuroscience Institute in the United States reported that data from the Oura Ring, a wearable sleep and activity tracker, can be combined with an app that measures vital signs that predict in advance if an individual is likely to develop COVID-19 symptoms.

The device successfully predicted that an individual would experience symptoms such as shortness of breath, cough, fever up to three days before they manifested.

“The wearable medical devices market is growing at a faster pace owing to the rising technological innovations and advancements, as they can improve the lifestyle of general population as well as patient population,” the report by Mordor Intelligence highlighted.

Wearable technologies proffer a convenient mode of monitoring physiological symptoms, featuring a multitude of advanced MedTech solutions.

Yehia is an investigative journalist and editor with extensive experience in the news industry as well as digital content creation across the board. He strives to bring the human element to his writing.

MedTech

Pfizer says COVID-19 vaccine more than 90% effective in kids

Published

 on

Kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the U.S. considers opening vaccinations to that age group.

The shots could begin in early November — with the first children in line fully protected by Christmas — if regulators give the go-ahead.

Details of Pfizer’s study were posted online. The Food and Drug Administration was expected to post its independent review of the company’s safety and effectiveness data later in the day.

Advisers to the FDA will publicly debate the evidence next week. If the agency ultimately authorizes the shots, the Centers for Disease Control and Prevention will make the final decision on who should receive them.

Full-strength Pfizer shots already are authorized for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem rising infections from the extra-contagious delta variant and help keep kids in school.

More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.

The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s roughly 28 million 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.

A Pfizer study tracked 2,268 kids in that age group who got two shots three weeks apart of either a placebo or the low-dose vaccine. Each dose was one-third the amount given to teens and adults.

Researchers calculated the low-dose vaccine was nearly 91% effective, based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.

In addition, young children given the low-dose shots developed coronavirus-fighting antibody levels just as strong as teens and young adults who got regular-strength vaccinations.

That’s important information considering that hospitalizations of mostly unvaccinated children reached record levels last month.

The CDC reported earlier this week that even as the delta mutant surged between June and September, Pfizer vaccinations were 93% effective at preventing hospitalizations among 12- to 18-year-olds.

Pfizer’s study of younger kids found the low-dose shots proved safe, with similar or fewer temporary side effects such as sore arms, fever or achiness that teens experience.

The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second dose, mostly in young men.

While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta mutant surged, the American Academy of Pediatrics says.

Moderna also is studying its COVID-19 shots in elementary school-age youngsters. Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year.


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Continue Reading

MedTech

FDA OKs mixing COVID vaccines; backs Moderna, J&J boosters

Published

 on

U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially.

The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when.

The latest moves would expand by tens of millions the number of Americans eligible for boosters and formally allow “mixing and matching” of shots — making it simpler to get another dose, especially for people who had a side effect from one brand but still want the proven protection of vaccination.

Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.

For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.

The FDA rulings differ because the vaccines are made differently, with different dosing schedules — and the J&J vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines.

As for mixing and matching, the FDA said it’s OK to use any brand for the booster regardless of which vaccination people got first. The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time.

FDA officials said they wanted to make the booster guidance as flexible as possible, given that many people don’t remember which brand of vaccine they received.

“Being able to interchange these vaccines is a good thing — it’s like what we do with flu vaccines,” FDA’s Dr. Peter Marks told reporters Wednesday evening. “Most people don’t know what brand of flu vaccine they received.”

Still, he added that many people will decide to get a booster from the same company as their initial vaccination.

The agency’s mix-and-match decision was based on preliminary results from a government study of different booster combinations that showed an extra dose of any type revs up levels of virus-fighting antibodies. That study also showed recipients of the single-dose J&J vaccination had a far bigger response if they got a full-strength Moderna booster or a Pfizer booster rather than a second J&J shot. The study didn’t test the half-dose Moderna booster.

Health authorities stress that the priority still is getting first shots to about 65 million eligible Americans who remain unvaccinated. But the booster campaign is meant to shore up protection against the virus amid signs that vaccine effectiveness is waning against mild infections, even though all three brands continue to protect against hospitalization and death.

“Today the currently available data suggest waning immunity in some populations of fully vaccinated people,” said FDA’s acting commissioner Dr. Janet Woodcock. “The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

The Moderna booster decision essentially matches FDA’s ruling that high-risk groups are eligible for the Pfizer vaccine, which is made with the same technology.

FDA recommended that everyone who’d gotten the single-shot J&J vaccine get a booster since it has consistently shown lower protection than its two-shot rivals. And several independent FDA advisers who backed the booster decision suggested J&J’s vaccine should have originally been designed to require two doses.

Experts continue to debate the rationale of the booster campaign. Some warn that the U.S. government hasn’t clearly articulated the goals of boosters given that the shots continue to head off the worst effects of COVID-19, and wonder if the aim is to tamp down on virus spread by curbing, at least temporarily, milder infections.

FDA regulators said they would move quickly to expand boosters to lower age groups, such as people in their 40s and 50s, if warranted.

“We are watching this very closely and will take action as appropriate to make sure that the maximum protection is provided to the population,” said Marks, the FDA’s top vaccine official.

In August, the Biden administration announced plans for an across-the-board booster campaign aimed at all U.S. adults, but outside experts have repeatedly argued against such a sweeping effort.

On Thursday an influential panel convened by the CDC is expected to offer more specifics on who should get boosters and when. Their recommendations are subject to approval by the CDC director.

The vast majority of the nearly 190 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while about 15 million have received the J&J vaccine.


WASHINGTON (AP)

Continue Reading

MedTech

FDA panel endorses booster shot for J&J COVID-19 vaccine

Published

 on

U.S. health advisers endorsed a booster of Johnson & Johnson’s COVID-19 vaccine Friday, citing concern that Americans who got the single-dose shot aren’t as protected as those given two-dose brands.

J&J told the Food and Drug Administration that an extra dose adds important protection as early as two months after initial vaccination — but that it might work better if people wait until six months later. Unable to settle the best timing, the FDA’s advisory panel voted unanimously that the booster should be offered at least two months after people got their earlier shot.

“I think this frankly was always a two-dose vaccine,” said FDA adviser Dr. Paul Offit of Children’s Hospital of Philadelphia. “It would be hard to recommend this as a single-dose vaccine at this point.”

The FDA isn’t bound by the recommendation as it makes a final decision — and adding to the debate’s complexity, new research also suggests that J&J recipients might have a stronger immune response if their booster dose is from a competing brand.

Preliminary results from an ongoing study of different ways to “mix and match” different shots showed that a booster of any sort revved up people’s levels of virus-fighting antibodies — at least for a few weeks. And the most dramatic jump came from giving a Pfizer or Moderna shot after the single-dose J&J vaccination.

FDA’s advisers didn’t vote on whether that should be recommended but told the government to allow flexibility with boosters, saying there were no safety red flags even if it’s not yet clear just how much difference, if any, mixing and matching may make in long-term protection.

“In the real world all these kind of combinations are already happening so I think it’s a matter of some urgency for the FDA to help sort out what is admittedly a complicated and challenging scenario,” said Dr. Ofer Levy of Boston Children’s Hospital.

The government says all three U.S. vaccines continue to offer strong protection against hospitalization and death from COVID-19, and that the priority is getting first shots to the 66 million eligible but unvaccinated Americans who are most at risk. But with the spread of the extra-contagious delta variant and signs of waning immunity against milder infections, the nation is moving toward a broader booster campaign.

Last month Pfizer boosters started being offered to seniors and younger adults at high risk from COVID-19 because of poor health, jobs or living conditions — at least six months after their initial vaccination. Thursday, the FDA advisory panel recommended the same approach for half-dose Moderna boosters.

But J&J’s vaccine has consistently shown lower effectiveness levels across a series of studies — and the FDA panel ultimately settled on another shot for any recipient 18 or older at least two months after their first vaccination.

“This is really — with the second dose — bringing it, I think, on par with those other vaccines in terms of effectiveness,” said Dr. Archana Chatterjee of Rosalind Franklin University.

The FDA will use its advisers’ recommendations to decide whether to authorize boosters for both J&J and Moderna. Next, the Centers for Disease Control and Prevention would rule on who should roll up their sleeves.

The vast majority of the 188 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while J&J recipients account for only about 15 million.

J&J’s vaccine is made with a different technology and on Friday, the company pitched its booster as a way to strengthen a robust vaccine that they said has retained its protective power over eight months. But FDA scientists pointedly challenged that assertion.

“There are data that suggest the effectiveness of this vaccine is actually less robust than the company’s presentation here,” said Dr. Peter Marks, FDA’s top vaccines official. “And that is a finding of concern particularly because that’s been seen in minority communities potentially and others.”

As for its booster, J&J presented results from a large study that found giving a second dose just two months after the first bumped protection against symptomatic COVID-19 to 94% from 70% in U.S. recipients. Giving that booster six months later instead prompted an even bigger jump in virus-fighting antibodies.

But in their own review, FDA scientists noted only a tiny portion of cases involved the delta variant, by far the dominant strain in the U.S. And while FDA’s reviewers found no new safety concerns about a second J&J dose, they noted other shortcomings. J&J followed booster recipients for little more than a month, making it hard to draw conclusions about the durability of protection. Also, FDA scientists stressed they hadn’t had time to independently confirm J&J’s data, which were submitted shortly before the meeting. That’s highly unusual and drew serious concern from the advisory panel.

The J&J vaccine was highly anticipated for its one-and-done formulation. But its rollout earlier this year was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the shot’s benefits outweighed those risks.


WASHINGTON (AP).

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Continue Reading

Trending