Diagnostics: Page 28
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Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
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The main black mark in an audit was the failure to publish draft guidance on content for premarket submissions for software in a medical device.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 -
Spencer Platt via Getty Images
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
FDA tells COVID-19 test makers to assess impact of variants in new EUA conditions
The agency's order to assess performance comes amid renewed focus on testing that's seen manufacturers add capacity and land contracts with the federal government worth more than $1 billion.
By Nick Paul Taylor • Sept. 24, 2021 -
GE Healthcare to buy BK Medical for $1.45B
The deal is aimed at expansion beyond diagnostics into surgical and therapeutic interventions, with high-single-digit return on invested capital anticipated by year five, CEO Kieran Murphy said.
By Greg Slabodkin • Sept. 23, 2021 -
EU threatens Illumina for closing $8B Grail deal while still under review
The European Commission's warning of fines and other measures is another step in a saga that could run for years. If the bloc ultimately opposes the acquisition, the path forward will be through the courts.
By Nick Paul Taylor • Sept. 22, 2021 -
Sarah Silbiger via Getty Images
Paige's AI-based software gets FDA nod to help doctors identify prostate cancer
It's the latest in a series of milestones for the startup, which has picked up 510(k) clearance for its image viewer, raised more than $220 million and partnered with Philips and Quest Diagnostics in recent years.
By Nick Paul Taylor • Sept. 22, 2021 -
Thermo Fisher COVID-19 testing forecast tops estimates, crushes 2022 guidance
The estimated $750 million in sales versus $365 million predicted by analysts comes amid the surge of the delta variant.
By Nick Paul Taylor • Sept. 20, 2021 -
Courtesy of Abbott
FDA warns of false positive risk of Abbott COVID-19 lab tests
CEO Robert Ford called rollout of the analyzer connected to the tests as a growth driver for the diagnostics business in July.
By Nick Paul Taylor • Sept. 20, 2021 -
Sarah Silbiger via Getty Images
FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study
The agency's response to the pandemic showed it can oversee lab-developed tests, according to Massachusetts General Hospital researchers. They contend that their study could inform legislation aimed at regulating such diagnostics.
By Nick Paul Taylor • Sept. 17, 2021 -
Hong Kong-based Prenetics to go public in US as part of $1.25B SPAC merger
Prenetics, which is set to pocket $459 million through the deal, will use the money to step up its attack on markets targeted by companies including 23andMe, Exact Sciences and Invitae.
By Nick Paul Taylor • Sept. 16, 2021 -
Alex Wong via Getty Images
CMS moves to scrap MCIT rule due to clinical evidence concerns
AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation.
By Nick Paul Taylor • Sept. 14, 2021 -
MedTech Europe calls for urgent clarification of EU artificial intelligence proposal
The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.
By Nick Paul Taylor • Sept. 13, 2021 -
Drew Angerer via Getty Images
Abbott, Quest, Quidel likely to benefit from Biden's COVID-19 testing push
Using the Defense Production Act, the White House will push for expanded test production, with $2 billion earmarked to buy nearly 300 million rapid antigen tests for schools, health centers and food banks.
By Greg Slabodkin • Sept. 10, 2021 -
Sarah Silbiger via Getty Images
FDA ends summer with fresh batch of breakthrough device designations
Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.
By Nick Paul Taylor • Sept. 10, 2021 -
Mario Tama via Getty Images
Jennifer Doudna-founded CRISPR biotech raises cash to move beyond diagnostics
Mammoth gained recognition earlier this year by developing a test for COVID-19 based on CRISPR science.
By Shoshana Dubnow • Sept. 9, 2021 -
EU expert panel starts accepting applications to review high-risk IVDs
The incoming IVD regulation, set to go into effect next May, requires certain diagnostics be reviewed by the committee and/or tested by a reference lab.
By Nick Paul Taylor • Sept. 7, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Abbott, Quest, Quidel scramble to add test capacity as delta variant surges
Quest Diagnostics is adding testing platforms in areas of the U.S. with high demand while manufacturers of at-home coronavirus tests such as Abbott and Quidel are ramping up capacity again after the early summer slump.
By Nick Paul Taylor • Sept. 3, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Cancer diagnoses stayed low even as initial COVID-19 crisis eased: Quest
Researchers warn cancers may continue to go undetected leading to a wave of patients with advanced stages of disease.
By Nick Paul Taylor • Sept. 1, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
BD gets emergency FDA nod for smartphone-enabled COVID-19 test
The medtech is launching the product against a backdrop of rising demand for similar diagnostics, as the delta wave spurs a surge in cases nationwide after a pullback in the first part of the year.
By Nick Paul Taylor • Aug. 27, 2021 -
EU builds out MDR, IVDR guidance ahead of flurry of implementing acts
The European Commission has advice on notified bodies, quality management systems and COVID-19 tests, among other topics, as medtechs work to comply with the new and looming regulations.
By Nick Paul Taylor • Aug. 24, 2021 -
SPAC slashes value of LumiraDx merger by $2B on falling COVID-19 testing forecast
LumiraDx recently halved its full-year sales guidance after being buffeted by the same forces rocking larger COVID-19 test providers such as Abbott and Quidel.
By Nick Paul Taylor • Aug. 23, 2021 -
Win McNamee via Getty Images
Biden said to rule out Woodcock as permanent FDA chief
A published report indicated the agency's longtime drug reviewer is no longer in consideration for the role, leaving it unfilled seven months into President Joe Biden's term.
By Jonathan Gardner • Aug. 20, 2021
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