Diagnostics
-
Philips beats Q4 expectations as COVID-19 boosts connected care, slows procedures
The Dutch conglomerate will continue to be active on the M&A front, CEO Frans van Houten told investors, after striking two deals in the space over the past month worth more than $3.4 billion.
By Nick Paul Taylor • Jan. 25, 2021 -
Healthcare funding shatters records in 2020, helped by COVID-19
Medical device startups raised roughly $6 billion in the fourth quarter, a high point over the last three years, according to a CB Insights report.
By Rebecca Pifer • Jan. 22, 2021 -
Brian Tucker/MedTech Dive
4 key trends for payers and providers in 2021
The COVID-19 crisis may spur speedier adoption of value-based care and partnerships between health systems and payers in the year ahead.
By Samantha Liss • Jan. 22, 2021 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
Q&AACLA seeks lab reimbursement changes as need for COVID-19 testing surges
Julie Khani, president of the American Clinical Laboratory Association, which includes Quest and LabCorp, says there are coverage gaps and that clarifications are needed for what tests are paid for by insurers.
By Greg Slabodkin • Jan. 22, 2021 -
Courtesy of Abbott Labs
Abbott antigen test misses two-thirds of COVID-19 asymptomatic cases: CDC
Compared to gold standard PCR tests, the company's point-of-care BinaxNOW diagnostic had a 35.8% sensitivity when used to analyze samples taken from individuals without symptoms, according to the agency.
By Nick Paul Taylor • Jan. 21, 2021 -
Getty Images
CMS rejects 1st colorectal cancer blood test, tweaks path for Exact, Guardant and others
The agency removed one of the criteria needed to secure Medicare coverage but still shunned Epigenomics' diagnostic. Rivals have versions in development.
By Nick Paul Taylor • Jan. 20, 2021 -
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 -
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 -
Jacob Bell / BioPharma Dive
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 -
Fotolia
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. 08, 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. 08, 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. 08, 2021 -
Jacob Bell
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. 07, 2021 -
Getty Images
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. 07, 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. 06, 2021 -
Jacob Bell / BioPharma Dive
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. 06, 2021 -
Fotolia
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. 05, 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. 05, 2021 -
Jacob Bell
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. 05, 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. 04, 2021
