Smith & Nephew, Quidel forecasts may signal improving ortho, diagnostics markets

The preliminary Q3 results are a positive sign for elective surgery volumes at other orthopaedics competitors such as J&J and Stryker and for COVID-19 antigen testing businesses including Abbott and BD.

By Nick Paul Taylor • Oct. 2, 2020

Ethylene oxide sterilizer rule pushed back by EPA

FDA held a related advisory panel late last year, where one member said the shutdown of device sterilization plants put the U.S. "on the cusp of a major medical logistical failure." COVID-19 has shifted the landscape.

By Maria Rachal • Oct. 1, 2020

5 ways COVID-19 is reshaping the medtech industry

Remote tech, clinical trials and marketing are a few of the areas disrupted by the pandemic this year — with changes that look set to stick around.

By Maria Rachal , Greg Slabodkin • Oct. 1, 2020

Medtronic hit with DOJ ventilator antitrust probe

The investigation comes amid allegations that industry consolidation contributed to a shortage of the breathing devices during the early months of the COVID-19 pandemic.   

By Greg Slabodkin • Oct. 1, 2020

COVID-19 spurred a medtech M&A boom this summer. Will it last?

Siemens Healthineers' CEO was rebuffed by his counterpart at Varian in January. But come May, the impact of coronavirus began to become clear. 

By Nick Paul Taylor • Sept. 30, 2020

Data, supply chain constraints still dog COVID-19 testing, NIH officials say

Former heads of BARDA and NESTcc highlighted a need for comparing test types and protocols as the U.S. seeks to boost point-of-care options for asymptomatic and pre-symptomatic people.

By Maria Rachal • Sept. 29, 2020

6.5M Abbott COVID-19 antigen tests to reach states this week

Initial distribution of the rapid point-of-care diagnostics is meant to help reopen economies and schools, President Donald Trump said. It's still far short of the 200 million some experts say are needed each month.

By Greg Slabodkin • Sept. 29, 2020

CMS lowers barriers for labs seeking COVID-19 test certification

Administrator Seema Verma said the new tools are designed to improve the "obscure process and outdated modes of payment" for labs to obtain CLIA certification to test for COVID-19 during the pandemic.

By Susan Kelly • Sept. 28, 2020

Hologic receives FDA emergency use for asymptomatic COVID-19 test

The nod for the test, which must be sent to a lab for results, comes as point-of-care tests that provide on-site results take off and are embraced by health officials and experts.

By Greg Slabodkin • Sept. 28, 2020

FDA grants EUA to first point-of-care COVID-19 antibody test

The lateral flow assay from Assure Tech achieved positive and negative percent agreements of 100% for IgG and IgM antibodies combined.

By Nick Paul Taylor • Sept. 24, 2020

Patient sentiment improving on elective procedures despite ongoing pandemic, survey suggests

A Needham & Company poll from this month found the time older U.S. consumers want to wait before feeling comfortable having surgeries again is shrinking compared to its August results.

By Maria Rachal • Sept. 23, 2020

Quest, Walmart pilot drone delivery of COVID-19 tests

The same-day service currently being tested in Las Vegas will use drones to drop at-home collection testing kits on driveways, front sidewalks and backyards.  

By Nick Paul Taylor • Sept. 23, 2020

Labs, diagnostics, dialysis sectors predicted to recover by year-end, but S&P cautious on device outlook

The analysts would "like to see the number of procedures stabilize, if not improve" before reconsidering predictions for the medical devices industry.

By Ron Shinkman • Sept. 21, 2020

Dexcom takes another step to keep CGMs in hospitals while Abbott targets athletes

By amassing early evidence in untapped populations, the companies hope to pursue lucrative new parts of the U.S. market.

By Maria Rachal • Sept. 18, 2020

Qiagen completes takeover of PCR automation player NeuMoDx for $248M

The still-independent Dutch molecular diagnostics company said NeuMoDx devices process test results three times as fast as some rival systems.

By Nick Paul Taylor • Sept. 18, 2020

PerkinElmer tops FDA COVID-19 test sensitivity list, with BD and Roche scoring lower

PerkinElmer’s coronavirus nucleic acid kit achieved the lowest limit of detection, indicating greater sensitivity or ability to accurately detect the virus, in an agency comparison of 58 tests.

By Nick Paul Taylor • Sept. 18, 2020

Nixed Philips, Hamilton, Vyaire ventilator contracts subject of expanding House probe

The oversight subcommittee wants to know if the HHS cancellation of "wasteful" contracts with the three medtechs included generous termination settlements involving payoffs to the companies. 

By Greg Slabodkin • Sept. 17, 2020

Cellex, Gauss ally to develop fully at-home, app-enabled COVID-19 antigen test

The first company to receive an FDA nod for a coronavirus antibody test is pairing its 15-minute antigen test with a smartphone app to automate interpretation of results. There might be a higher likelihood of false negatives.

By Nick Paul Taylor • Sept. 17, 2020

Moody's raises medtech outlook amid testing boom at Abbott, Thermo Fisher

But the investors service warned the pace of innovation in the COVID-19 test sector may render some products obsolete and create winners and losers.

By Nick Paul Taylor • Sept. 17, 2020

Roche gets FDA nod for faster combo coronavirus-flu test

The diagnostic, designed to detect and differentiate SARS-CoV-2 and influenzas A and B, gives results within 20 minutes, compared to a prior authorized version for a Roche system with an hours-long turnaround.

By Greg Slabodkin • Sept. 16, 2020

Intersect ENT strikes €60 Fiagon buyout to expand in balloon sinuplasty

The takeover of the German electromagnetic surgical navigation specialist comes two months after a report that Medtronic moved to acquire Intersect.

By Nick Paul Taylor • Sept. 16, 2020

NIH funds up to $23M to IBM, Evidation and others for COVID-19 digital health tech

Seven entities will receive money to work on detecting coronavirus cases and identifying their contacts by leveraging data from smartphones and wearables. 

By Nick Paul Taylor • Sept. 16, 2020

Medtronic, Stryker among CEOs weighing in on COVID-19 recovery

Execs at Boston Scientific and Edwards also presented at the Morgan Stanley Global Healthcare Conference this week, casting optimism on a year-end return to growth after springtime lows.

By Maria Rachal , Susan Kelly • Sept. 15, 2020

BD probes COVID-19 false positives with point-of-care systems

The medtech's antigen tests have spurred demand from the federal government and states, but may be turning up incorrect results in nursing homes, The Wall Street Journal reported and the company confirmed Tuesday morning.

By Maria Rachal • Sept. 15, 2020

After uneven start to 2020, Hologic becomes Wall Street darling

An update Friday from the medtech that organic year-over-year revenue growth may reach 60% this quarter impressed some analysts, many of whom see capitalization in the COVID-19 environment being sustainable.

By Maria Rachal • Sept. 14, 2020