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

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

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

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

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

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

Abbott antigen test gets FDA nod as first at-home, virtually guided COVID-19 diagnostic

BinaxNOW requires a prescription and a telehealth service to take users through collection. However, public health experts question why prescriptions are being required at all for such tests.

By Greg Slabodkin • Dec. 17, 2020

FDA grants EUA for first fully at-home COVID-19 test without a prescription

The rapid antigen test from Australian company Ellume will be available over the counter for people with or without symptoms and delivers results in about 20 minutes.

By Susan Kelly • Dec. 15, 2020

MDR-IVDR bottleneck persists as EU launches 1st Eudamed module

"Very few notified bodies at this moment in time are taking new products on under the old directive, because a medical device doesn't just get certified overnight," an official at Ireland's National Standards Authority said.

By Nicholas Wallace • Dec. 14, 2020

Roche and Siemens COVID-19 antibody tests shine in FDA accuracy roundup

Abbott's tests seemed to perform slightly worse than the best serology assays but comparably to kits from some other leading diagnostic players such as Beckman Coulter. 

By Nick Paul Taylor • Dec. 14, 2020

UK shares post-Brexit device guidance as uncertainty around EU split looms

MHRA this week outlined which medtech manufacturers will need to register and when. The timeline is determined by the previously disclosed grace period which ends Jan. 1, 2021.

By Nick Paul Taylor • Dec. 11, 2020

LabCorp gets EUA for first at-home collection COVID-19 test with no prescription

The lab giant is selling the kit through its consumer-focused Pixel website and may expand into retail channels. The agency is hoping the over-the-counter diagnostic will spur more testing.

By Nick Paul Taylor • Dec. 10, 2020

Roche, Thermo Fisher ally with COVID-19 vaccine developers on antibody testing

The companies are working with Moderna and the University of Oxford to quantitatively measure the antibody levels of recipients of the shots.

By Nick Paul Taylor • Dec. 10, 2020

Qiagen ups outlook, predicts double-digit non-COVID product growth amid analyst skepticism

Wall Street is not yet persuaded the company's post-pandemic future is bright. William Blair analysts said they want to "see some signs of execution on growth in a post-COVID-19 world." 

By Nick Paul Taylor • Dec. 9, 2020

Company of the Year: Abbott

Demand for the diversified medtech's array of coronavirus tests puts it on solid financial ground going into 2021, amid a challenging year for the medical device industry.

By Maria Rachal • Dec. 9, 2020

Executive of the Year: Doug Bryant, Quidel

The veteran of Abbott has been at the helm for nearly 12 years, setting the company up for opportunities when the COVID-19 pandemic hit in early 2020 to leverage its point-of-care antigen testing.

By Greg Slabodkin • Dec. 9, 2020

Regulatory Disruption of the Year: HHS lab developed test policy

The surprise move to no longer require FDA premarket review for laboratory developed tests spurred backlash across a spectrum of public health experts and industry.

By Greg Slabodkin • Dec. 9, 2020

The MedTech Dive Awards for 2020

From the relentless demand for COVID-19 tests to the pressure on medtechs' traditional business lines, the industry has faced unprecedented market forces this year.

By MedTech Dive Team • Dec. 9, 2020

Quest gets first FDA nod for at-home collection coronavirus-flu combo test

The lab giant is using Roche’s diagnostic and instrument, which received an emergency use authorization in September, with its own process for testing samples collected by consumers.

By Nick Paul Taylor • Dec. 7, 2020

Olympus to pay $300M to buy Veran for lung navigation system

The deal is for $300 million up front, with another $40 million tied to an undisclosed milestone.

By Nick Paul Taylor • Dec. 7, 2020

Siemens COVID-19 test gets high marks on FDA sensitivity list, beating Abbott, BD and Roche

A PerkinElmer test still holds the top position among coronavirus diagnostics least likely to return false negatives.

By Nick Paul Taylor • Dec. 4, 2020

CDRH headed for 'reset' in 2021 after COVID-19 derailed priorities, Shuren says

After a "massive increase" in work due to the pandemic, the device center anticipates continuing to manage coronavirus projects while also focusing on MDUFA V and new programs.

By Ricky Zipp • Dec. 3, 2020

EU underscores remote notified body audit policy amid pandemic

MedTech Europe has pressed the Commission to expand such reviews to the incoming MDR and IVDR regs, but a new Q&A notes the scope is limited to the directives and devices considered "clinically necessary" during the crisis.

By Nick Paul Taylor • Dec. 3, 2020