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

Explore the Trendline➔

Top 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

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

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

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

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

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

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