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

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

Hospitals prepare to reveal prices online come Jan. 1

The rule requires hospitals to prepare a list of pricing information for 300 "shoppable services," such as total knee replacements. However, experts question if the data will benefit consumers.

By Samantha Liss • Dec. 8, 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

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

CMS adds hip replacements, other surgeries to ASC list in final rule

A representative from Stryker applauded the changes and said the rule will encourage providers to consider the shift to ambulatory surgery centers.

By Ricky Zipp • Updated Dec. 4, 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

Everlywell raises $175M to expand at-home health testing, virtual care services

The startup was first to win FDA emergency approval for a COVID-19 test self-collection kit. Sales of most tests are growing more than 100% year over year, driven by deals with Target, Walgreens and CVS, though competition is rising.

By Nick Paul Taylor • Dec. 3, 2020

Medtechs, working with FDA, offer guidance for remote control of medical devices during pandemic

GE Healthcare, Medtronic, Philips and ResMed are among those that have modified products with such capabilities to create safe physical distance between providers and COVID-19 patients.

By Greg Slabodkin • Dec. 2, 2020

Nevro Q4 sales to drop as COVID-19 headwinds stiffen: analysts

If the change in tone reflects growing unwillingness of patients to get elective care as cases surge, as Baird analysts believe, the update could have implications for other medical device companies.

By Nick Paul Taylor • Dec. 1, 2020

Fitbit data suggests potential for early COVID-19 detection using wearables

While the algorithm would generate far more false than true positives even when prevalence is high, researchers argue it could encourage more testing and precautions. The results have yet to be validated in a prospective study.

By Nick Paul Taylor • Dec. 1, 2020

CMS expands ability for hospital-level care at home ahead of holiday virus spread

Six health systems received waivers to treat more than 60 acute conditions under the new program, which also tweaks earlier changes allowing ambulatory surgical centers to provide greater inpatient care. 

By Shannon Muchmore • Nov. 30, 2020

Healthcare deals in Q4 predicted to fall from record-setting Q3: report

Market research firm CB Insights believes the drop will carry over into the digital health sector too, an area that's seen historic investor interest in 2020 amid the coronavirus pandemic.

By Rebecca Pifer • Nov. 25, 2020

Hospitals adopt new round of elective surgery restrictions, brace for Thanksgiving COVID-19 surge

The American College of Surgeons is among those placing new emphasis on factoring healthcare worker wellbeing into capacity decisions.

By Maria Rachal • Nov. 25, 2020

Medtronic ends earnings season with mixed results vs. TAVR rival Edwards

The medtech giant's financials reported Tuesday, with a month more of COVID-19 trends factored in compared to competitors, also show some divergence in the spine and neuromodulation markets.

By Nick Paul Taylor • Nov. 25, 2020

Medtronic details diabetes, TAVR offensives as COVID-19 recovery progresses

Q2 data shows how Medtronic's turnabout has been faster than expected, but the company declined to give future guidance because of the global coronavirus resurgence, CEO Geoff Martha said.

By Greg Slabodkin • Nov. 24, 2020

MedTech Europe backs proposed EU Health Union but flags potential hangups

The trade group fears moving responsibility for administering the IVDR and MDR expert panels to the European Medicines Agency could slow deployment.

By Nick Paul Taylor • Nov. 20, 2020

Notified bodies report early success with remote audits but challenges remain

While there have been benefits to going remote during the pandemic, 57% of those polled by a European trade group say they take longer than on-site assessments and most encounter problems due to poor network connections.

By Nick Paul Taylor • Nov. 20, 2020

HHS piloting Cue's NBA-tested rapid COVID-19 diagnostic in 5 states

Unlike lab-based molecular tests, which can take two to three days to turn around, Cue Health's point-of-care molecular test generates results in about 20 minutes.

By Maria Rachal • Nov. 19, 2020

Older patients less willing to have elective procedures as COVID-19 surges: survey

Patient sentiment has deteriorated since September, according to findings from Needham, even as medtech companies have taken steps to encourage a return to care.

By Nick Paul Taylor • Nov. 19, 2020

Health insurers, labs point fingers over COVID-19 test coverage and prices

An AHIP study of claims data is the latest volley in a debate about who ultimately foots the bill for coronavirus diagnostics. ACLA blames "murky" tri-agency guidance for coverage denials and high out-of-pocket costs. 

By Nick Paul Taylor , Greg Slabodkin • Nov. 19, 2020

Hospitals across US cancel elective procedures — again

Although distinct from wholesale shutdowns earlier this year, health systems from Chicago to El Paso are again putting off non-emergency care, which often includes joint replacement surgeries.

By Hailey Mensik • Nov. 18, 2020