Diagnostics: Page 26
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Thermo Fisher, Hologic ride wave of COVID-19 test demand, for now
The two lateral flow assay companies reported strong coronavirus testing sales in the latest quarter. However, Hologic CFO Karleen Oberton told investors late Monday the pandemic remains unpredictable.
By Greg Slabodkin • Nov. 2, 2021 -
Siemens' Varian leads latest FDA breakthrough device designations
Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.
By Nick Paul Taylor • Nov. 1, 2021 -
Trendline
Medical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
FDA, global peers create guiding principles for AI/ML medical devices
The U.S., U.K. and Canada are seeking international harmonization as part of a broader discussion on the development of safe, effective devices that use artificial intelligence and machine learning.
By Nick Paul Taylor • Oct. 29, 2021 -
FDA's 2022 A-list guidance plan hits on software, post-pandemic future
The agency's priorities include a much-anticipated final guidance on clinical decision support software — more than five years in the making — meant to clarify when CDS meets the definition of a medical device.
By Nick Paul Taylor • Oct. 27, 2021 -
Notified bodies join chorus of criticism of proposed European AI regs
Team-NB has come out strongly against the regulation, arguing it will add to administrative burdens, reduce notified body capacity and create confusion.
By Nick Paul Taylor • Oct. 26, 2021 -
Amazon teases 5 more cities to get virtual Amazon Care offering this year
Amazon Care is currently live in the Washington, D.C. and Baltimore area, and will be rolled out in Dallas, Chicago, Philadelphia, Boston and Los Angeles this year, the unit's director told the HLTH conference this week.
By Rebecca Pifer • Oct. 22, 2021 -
Abbott, Intuitive, J&J set tone for earnings: Testing up, procedures down
The medtechs in recent days confirmed the mixed financial impact of the delta wave and early signs of recovery in elective procedures in the U.S. Reports from Boston Scientific and Stryker come next week.
By Nick Paul Taylor • Oct. 21, 2021 -
Abbott COVID-19 sales rebound, but calls market too volatile for 2022 forecast
CEO Robert Ford warned investors that despite a big uptick driven by the delta surge, "we'll have to update on a rolling quarterly basis."
By Greg Slabodkin • Oct. 20, 2021 -
In last ditch plea to save MCIT, medtech groups suggest fixes to CMS
AdvaMed and MDMA responded to a call for feedback on the planned repeal of the Medicare Coverage of Innovative Technology pathway by proposing tweaks and new ideas to salvage it.
By Nick Paul Taylor • Oct. 20, 2021 -
Abbott software causing COVID-19 test false positives, starts Class I recall fix
FDA said use of the tests before the problem is corrected may cause serious adverse health consequences or death, alerting laboratories to treat the results as presumptive and that they may need to be confirmed with another test.
By Nick Paul Taylor • Oct. 19, 2021 -
The European Commission has caved to pressure on extending IVDR. Now what?
The EC's proposal creates a new set of timelines for the industry to meet and questions to consider — assuming it passes into law without further changes.
By Nick Paul Taylor • Oct. 15, 2021 -
Medtronic pledges R&D boost, brand refresh, amid rising Big Tech rivalry
CEO Geoff Martha said the device giant is still "building out that direct-to-consumer muscle" and acknowledged "healthy competition" with the likes of Apple and Google.
By Greg Slabodkin • Oct. 14, 2021 -
EU proposes to delay IVD Medical Device Regulation, citing COVID-19 backlog
Originally set to go into effect in May 2022, a progressive rollout is now planned. The proposal will now go to the European Parliament and Council for adoption, according to the announcement.
By Kim Dixon • Updated Oct. 14, 2021 -
FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response
The agency gave the designation to Quanterix's blood test, which has the potential to aid evaluation of people who present with cognitive impairment, and Nonagen Bioscience's non-invasive bladder cancer test.
By Nick Paul Taylor • Oct. 12, 2021 -
4 takeaways from a bumper year of M&A medtech activity (so far)
After hunkering down last year, many companies entered 2021 with large cash reserves and acquisition targets that included players lacking scale to weather the downturn.
By Nick Paul Taylor • Oct. 11, 2021 -
Quidel hikes revenue forecast, riding COVID-19 testing wave
CEO Doug Bryant cautioned that "demand can change very quickly," while Craig-Hallum analysts said future coronavirus-related sales remain "unforecastable."
By Greg Slabodkin • Oct. 8, 2021 -
Labcorp, PerkinElmer latest to target COVID-flu combo test market
FDA gave a nod to Labcorp's diagnostic, which uses a Roche test for SARS-CoV-2, influenza A and influenza B. PerkinElmer's assay also got emergency authorization for those three viruses as well as respiratory syncytial virus.
By Greg Slabodkin • Oct. 7, 2021 -
Medtechs opened 2021 with a flurry of M&A and have not stopped spending since
With deals ranging from tuck-ins to multibillion-dollar takeovers, here's a roundup of the M&A spree so far this year after activity came to a near halt amid the unpredictability of 2020.
Oct. 7, 2021 -
FDA labels Ellume's recent COVID-19 Home Test recall Class I event
The agency said there have been 35 reports of false positive results but no deaths reported. More than 2.2 million devices are being recalled in the U.S.
By Nick Paul Taylor • Updated Nov. 10, 2021 -
Acon gets FDA nod for home COVID-19 test kit amid surging US demand
The diagnostics maker secured authorization for its over-the-counter antigen test amid a nationwide testing shortage. Abbott and Quidel are scaling up production but it could take months to boost output.
By Nick Paul Taylor • Oct. 5, 2021 -
FDA's real-world evidence push hampered by data challenges, 'million-dollar question'
While the agency wants to tap information like electronic health records and wearables to make pre- and postmarket decisions, these sources do not have the same quality controls as clinical trials.
By Greg Slabodkin • Oct. 4, 2021 -
FDA hits nearly all MDUFA IV commitments despite pandemic disruptions
The main black mark in an audit was the failure to publish draft guidance on content for premarket submissions for software in a medical device.
By Nick Paul Taylor • Oct. 4, 2021 -
MedTech Europe director warns about EU's turbulent switch to IVDR
Oliver Bisazza told the AdvaMed conference this week that while the European Union will "needlessly lose a great deal of tests" in the transition to the In Vitro Diagnostic Regulation, he is confident decision makers will "course correct."
By Nick Paul Taylor • Sept. 30, 2021 -
Amid pandemic, medtech R&D, merger activity jumped: EY report
Research and development spending at pure-play medtechs rose to a level last seen before the 2007-2008 financial crisis.
By Nick Paul Taylor • Sept. 27, 2021 -
Cue, Google's COVID-19 test provider, raises $200M in IPO
The at-home test maker will use the money to scale up commercial and manufacturing infrastructure to support its portable diagnostic platform. Cue Health's Friday debut on the Nasdaq valued the company at $2.9 billion.
By Nick Paul Taylor • Sept. 27, 2021