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. 8, 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. 8, 2021

Explore the 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 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. 7, 2021

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. 7, 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. 6, 2021

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. 6, 2021

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. 5, 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. 5, 2021

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

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