Diagnostics: Page 36
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Forging trust in AI, sustaining the virtual care boom and other CES takeaways
"You can't just set a piece of software in front of somebody and say 'trust me,'" Christina Silcox, digital health fellow at the Duke-Margolis Center for Health Policy, said at the consumer tech conference.
By Rebecca Pifer • Jan. 19, 2021 -
Thermo Fisher buys Mesa Biotech for $450M to bolster rapid point-of-care testing
The all-cash acquisition, which includes the potential for an additional $100 million upon completion of milestones, adds Mesa's PCR test platform for SARS-CoV-2, influenza A and B, RSV and strep A to Thermo's portfolio.
By Greg Slabodkin • Jan. 19, 2021 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Abbott, Quidel tout big COVID-19 testing year despite vaccine rollout: JPM21
"I don't see COVID just simply going away, but I do see it looking more like a flu-like seasonal test. And if you think about it globally, it's a pretty significant amount of volume," Abbott CEO Robert Ford said at J.P. Morgan's conference.
By Greg Slabodkin • Jan. 15, 2021 -
CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic
The policy gives developers of FDA-designated breakthrough products coverage for Medicare's 60 million beneficiaries on the day of approval.
By Nick Paul Taylor • Jan. 13, 2021 -
3 takeaways from JP Morgan: Electives, M&A and looking past COVID-19
Execs from Medtronic, Baxter and BD are among those previewing the year ahead at the bank's annual healthcare conference.
By Greg Slabodkin , Ricky Zipp • Jan. 12, 2021 -
In medtech win, MDR-IVDR remote audits OK'd amid pandemic pressures
An official for MedTech Europe, which pushed for flexibility ahead of new medical device rules set to kick in later this year, called the move "significant and positive."
By Nick Paul Taylor • Jan. 12, 2021 -
FDA flags COVID-19 false negative risk from virus variant of Thermo Fisher, Applied DNA and Mesa tests
Sensitivity may be affected by emerging forms of the virus, though the agency said "the impact does not appear to be significant." In fact, the tests may help to spot where a fast-spreading variant is prevalent.
By Nick Paul Taylor • Jan. 11, 2021 -
Medtech M&A to take off after pandemic slowed deals in 2020: EY
Dealmaking in 2021 will be fueled by financial firepower across the industry at an "all-time high" of nearly $500 billion, according to the consultants.
By Ricky Zipp • Jan. 10, 2021 -
"White House Press Briefing". Retrieved from The White House.
HHS allocates $300M for Abbott COVID-19 rapid tests or 'equivalent' testing tech
The agency has yet to decide if it will purchase Abbott's or a similar diagnostic from a rival, Assistant Secretary for Health Brett Giroir said Thursday.
By Greg Slabodkin • Jan. 8, 2021 -
Permission granted by Quidel Corporation
Quidel prelim Q4 revenue miss 'a big surprise' to Wall Street
Later-than-expected FDA approvals and supply chain challenges were among the factors, analysts suggested. But they are still optimistic about the company's near term prospects.
By Ricky Zipp • Jan. 8, 2021 -
PerkinElmer inks $591M Oxford Immunotec buy to challenge Qiagen in TB market
The deal comes amid a flurry of medtech M&A during the first week of 2021. Hologic inked two acquisitions in the women's health space and Stryker said it would buy sensor maker OrthoSensor.
By Nick Paul Taylor • Jan. 8, 2021 -
FDA tracks impact of COVID-19 mutations on test performance
The agency is concerned existing tests might miss new variants, Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said. Thermo Fisher's Taqpath COVID-19 assay may detect the U.K. version.
By Greg Slabodkin • Jan. 7, 2021 -
Wall Street paints rosy 2021 for medtech as electives snap back
After economic challenges throughout 2020, sell-side analysts predict procedure-dependent companies like Medtronic, Abbott and Zimmer Biomet to outperform this year as procedure volumes return.
By Ricky Zipp • Jan. 7, 2021 -
Hologic's $230M Biotheranostics buy its 2nd M&A deal of 2021
Some Wall Street analysts were surprised by the target, but others suggested the move could strengthen the company for a post-coronavirus environment.
By Ricky Zipp • Jan. 6, 2021 -
FDA finalizes speedier medical device pathway alternative to breakthrough status
Final guidance for the voluntary Safer Technologies Program features changes to draft sections criticized by AdvaMed, specifically what qualifies as a "significant" improvement to patient safety.
By Nick Paul Taylor • Jan. 6, 2021 -
Color raises $167M to scale up US testing and telehealth services
The health technology company, with a valuation of $1.5 billion, intends to use the money to help build a national tech-based public health infrastructure capable of providing healthcare services to large populations.
By Nick Paul Taylor • Jan. 5, 2021 -
Hologic eyes future post COVID-19 with Somatex Medical tuck-in
The medical device maker is bulking up its women's health business as molecular diagnostics sales surge due to the pandemic. Wall Street analysts have said these lines are equipped to withstand market uncertainties.
By Susan Kelly • Jan. 5, 2021 -
FDA flags false negative risk of startup Curative's COVID-19 test
The Los Angeles-based firm was founded in January 2020 to focus on sepsis but has since pivoted to focus on coronavirus. Justin Mateen, founder of dating app Tinder, is its lead investor, according to Crunchbase.
By Nick Paul Taylor • Jan. 5, 2021 -
Brexit deal creates regulatory barriers to UK-EU medical device trade
The new arrangement lacks provisions for the mutual recognition of standards, forcing products made in the U.K. to undergo an extra certification step to enter the EU market.
By Nick Paul Taylor • Jan. 4, 2021 -
Medtronic, J&J and Edwards among medtechs to headline at JP Morgan
Players in the COVID-19 diagnostic sector and red-hot liquid biopsy space are also set to present, making the event a chance to assess the state of the industry as it tries to move on from a turbulent 2020.
By Nick Paul Taylor • Jan. 4, 2021 -
The top medtech deals of 2020 (and one that got away)
M&A activity bounced back in the second half of the year, with deals ranging from Teladoc's $18.5 billion Livongo buy to Stryker's drawn-out $4 billion acquisition of Wright Medical.
By Susan Kelly • Jan. 4, 2021 -
Philips clinical-grade wearable study in early COVID-19 detection gets DoD funds
The project will assess the FDA-cleared BioSticker, coming a week after the Dutch medtech giant doubled down on remote patient monitoring by scooping up BioTelemetry for $2.8 billion.
By Nick Paul Taylor • Dec. 23, 2020 -
Permission granted by Quidel Corporation
Quidel gets EUA to rival Abbott's rapid, point-of-care antigen test
The pregnancy-like diagnostic is up to five minutes faster than the big medtech's equivalent test and, based on current data, may be more sensitive.
By Nick Paul Taylor • Dec. 22, 2020 -
Courtesy of Abbott Labs
Abbott to supply 30M COVID-19 diagnostics to HHS as Beckman Coulter targets mass testing
The buy comes on top of a $760M purchase of Abbott's point-of-care tests in August. Beckman Coulter is filing for emergency use with FDA.
By Greg Slabodkin • Dec. 18, 2020 -
Courtesy of Quest Diagnostics
Testing demand for Labcorp, Quest robust even as COVID-19 vaccine administration begins
Quest Diagnostics this week raised its outlook for 2020 earnings and revenue on higher-than-expected demand for coronavirus tests. Jefferies analysts see similarly strong demand at LabCorp after checking in with executives.
By Susan Kelly • Dec. 18, 2020
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