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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
FDA updates impact of mutations on COVID-19 tests, adds Cepheid to list of affected products
A new agency webpage features the latest information about the potential impact of viral mutations on molecular diagnostics such as Cepheid's Xpert line of rapid SARS-CoV-2 tests.
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A year into the pandemic, advanced cancer diagnoses are rising
Research from radiation oncologists and molecular pathologists add to evidence showing that many people skipped getting cancer screenings in 2020 as they avoided going to the doctor to minimize the risk of COVID-19 infection.
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FDA panel to probe Endologix, broader stent graft safety in Q4
The agency is mulling further action to address blood leak risks with the medtech's grafts for abdominal aortic aneurysms and surveillance strategies for all AAA endovascular grafts. Medtronic and Cook also sell the products.
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Analysts tip surgeries to rebound. Rising COVID-19 cases threaten those forecasts.
Two Wall Street reviews suggest people are visiting hospitals more and are increasingly comfortable with undergoing elective care, but they come amid the CDC chief's warning that rising hospitalizations may jeopardize progress.
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Medtronic's Harmony pulmonary valve wins FDA approval
The device is the first non-surgical heart valve cleared in the U.S. to treat a severe form of pulmonary valve regurgitation that usually results from a congenital heart defect.
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Helius gets FDA nod for neuromodulator after pivoting to multiple sclerosis
The non-implantable device delivers neuromuscular stimulation to an MS patient's tongue, sending electrical signals to the central nervous system as a short-term treatment of gait deficit.
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Abbott, Quest, Roche among cos pitching K-12 COVID-19 test plan to tap into Biden's $10B fund
A who's who of sector companies are teaming with the Rockefeller Foundation on the proposal. The industry stands to benefit from widespread school testing as symptomatic demand diminishes.
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Boston Scientific links just approved liver cancer device to improved survival
Analysts at Evercore ISI estimate FDA clearance for the radioactive glass beads opens up a $150 million U.S. market opportunity, although they note lack of data from a randomized trial "could be a factor in modeling adoption."
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Hospitals flailed amid COVID-19 crisis, are unsure of future, OIG says
Executives said they were worried about their workers experiencing trauma and concerned a shrinking recruitment pool for nurses could exacerbate staffing shortages.
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Stryker, Zimmer make data and analytics a top priority as robotic procedures ramp up
Through partnerships with big tech or developments of smart implants, the orthopaedic companies say tapping troves of patient data is the next logical strategic step.
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Thermo Fisher pivots COVID-19 approach with air detection, school testing
The company is looking to new strategies as vaccines drive down cases and institutions like schools, hospitals and businesses re-open.
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Drugmakers flock to Vineti's fix for a cell, gene therapy problem
The San Francisco-based tech company wants to establish a patient identifier akin to a digital ID badge that could work for all types of advanced medicines and improve traceability, control costs and better ensure patient safety.
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Baxter, digital health startups lead pushback against 510(k) exemptions
Companies argued in public comments that relaxing certain FDA regulations could put consumer safety at risk. Roche was a rare supporter, arguing the changes would "free up much needed FDA resources."
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Roche bets COVID-19 vaccination drive to favor PCR over antigen testing
Wall Street analysts contend the Swiss diagnostic company's argument could bode well for Abbott, Hologic, Thermo Fisher Scientific and PerkinElmer.
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Boston Scientific to pay $188.6M to settle mesh claims in 47 states
The agreement with the attorneys general settles allegations the medtech giant misrepresented or failed to disclose to patients all of the potential risks involved with the vaginal implants.
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Cancer screenings bounced back after steep pandemic declines, Rand report shows
The rate of women seeking mammograms was higher by the end of July than in the months leading up to the pandemic, though colonoscopies did not return to pre-pandemic levels, researchers found.
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Insulet's Omnipod 5 trial shows benefits across patient groups with Type 1 diabetes
The long-awaited results showed a reduction in blood sugar levels and increase in daily time spent in desired blood sugar ranges for younger and older patients. Wall Street analysts called the findings expected but still strong.
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FDA grants EUA to COVID-19 screening device using machine learning
While the product gives institutions another screening tool for those without symptoms, Tiger Tech faces competition with antigen testing scaling up.
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ASCs gave medtechs alternate care sites amid pandemic hospital elective shutdown
After surgeries moved to ambulatory surgery centers during the pandemic's upending of non-emergency care, experts and industry believe some procedures may never go back.
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National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
FDA's 1st full OK to BioFire's COVID-19 test clears shorter path for others
Full agency approval of the diagnostic, now permitted to be marketed beyond the public health emergency, lets other companies secure non-emergency authorizations through a 510(k).
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AstraZeneca, Oxford vaccine prevents COVID-19 in big US study amid controversy overseas
A two-shot regimen was 79% effective at protecting people from COVID-19, which should support the fourth clearance of a vaccine in the U.S. and calm safety concerns abroad.
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EU group proposes minimum standards for rapid antibody COVID-19 tests
Antibody tests of questionable accuracy proliferated on both sides of the Atlantic early in the pandemic, leading the U.S. and European Union to try to raise standards.
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Abbott awarded $255M federal contract for rapid COVID-19 antigen tests
The company will initially provide 50 million of its point-of-care diagnostics to HHS for use in Florida and Maine, with the potential for up to $766 million under the eight-month deal.
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Deep Dive
Robotics demand held firm as pandemic pummeled electives
Intuitive Surgical, Stryker and Zimmer Biomet all saw procedure volumes drop in 2020 as electives shut down. However, system demand remained strong despite the financial hit to hospitals.
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CGM patients seen rising 38% in 2021 fueled by Type 2 diabetes: poll
Dexcom and Abbott are expected to benefit the most from the booming space, while Medtronic is expected to lose ground in the Type 1 market, according to an SVB Leerink survey of 101 endocrinologists and nurse practitioners.