Medtechs eye key role of ASCs in return of elective care

Elective procedures were increasingly moving from hospitals to lower-cost ambulatory surgery centers prior to COVID-19. Now, ASCs may have a new advantage as a setting where patients feel safer returning to care.

By Maria Rachal • May 26, 2020

ResMed, Medtronic embrace remote tech amid COVID-19, say it's here to stay

The crisis has sped adoption of digital health technologies to help hospitals create safe physical distances between healthcare workers and patients. Execs say some could become permanent products.

By Greg Slabodkin • May 26, 2020

Martha plots M&A, Hugo robot sees delay: Takeaways from Medtronic's Q4

Despite the negative impacts of COVID-19 on revenue in the latest quarter, the medtech giant has its strongest balance sheet in years and is looking for acquisition opportunities in the pandemic landscape.

By Maria Rachal , Greg Slabodkin • May 22, 2020

FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions

Companies that market medical devices under premarket approvals or humanitarian device exemptions can make limited modifications to design and production without giving prior notice, according to special guidance.

By Nick Paul Taylor • May 22, 2020

Abbott, Roche ink deals with UK for 10M coronavirus antibody tests

The notice from the government, which bought $20 million in unreliable antibody tests early in the crisis, came as FDA removed 28 products from a list of the tests that can be used without emergency use authorizations.

By Nick Paul Taylor • May 22, 2020

April was dismal for US hospitals, with long road ahead, surveys find

Operating margins plummeted 174% last month compared to April 2019 and were down 118% from March of this year as surgeries, ER visits and outpatient appointments declined drastically during the COVID-19 pandemic.

By Shannon Muchmore • May 21, 2020

Medtronic's revenue dropped 26% in Q4 as coronavirus hit broadly

New CEO Geoff Martha told investors Thursday nearly all sides of the business were negatively impacted by the pandemic's effects. 

By Greg Slabodkin • May 21, 2020

Hospitals push FEMA to form broad supply pact with medtech

The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.

By Nick Paul Taylor • Updated May 26, 2020

AdvaMed, health systems set ground rules for return of sales reps

Hospitals, nurses and the medtech industry issued guidance to pave the way for device company representatives to re-enter healthcare facilities.

By Susan Kelly • May 20, 2020

COVID-19 drives EC to change rules on notified body designations

The European Commission is allowing certain deviations from normal procedures governing notified bodies, enabling renewal of designations under the outgoing device regulations without performing on-site assessments.

By Nick Paul Taylor • May 20, 2020

Labs welcome CMS rate for coronavirus antibody testing

Analysts at William Blair said the roughly $42 rate for common serological tests is higher than expected, which may bode well for antigen testing reimbursement.

By Nick Paul Taylor • May 20, 2020

Coronavirus pushes Mayo Clinic's operating income into free fall

Operating income plunged 88% by the end of the first quarter due to the pandemic and the near closure of the health system's outpatient business. Still, Mayo has become a leader in COVID-19 testing. 

By Samantha Liss • May 19, 2020

Investors bet diabetes tech immune to full brunt of COVID-19

Pure play diabetes device makers aren't clear yet on how economic uncertainty and the transition to telemedicine may affect new patient demand, but are outperforming the stock market by a long shot.

By Maria Rachal • May 19, 2020

Philips lung ultrasound, Beckman sepsis diagnostic receive BARDA coronavirus backing

The separate projects aim to incorporate machine learning algorithms to enhance technologies meant to support COVID-19 patients.

By Susan Kelly • May 19, 2020

FDA OKs 1st at-home collection kit for use with multiple labs, coronavirus tests

The emergency use authorization to Everlywell follows earlier nods to LabCorp and Rutgers Clinical Genomics Laboratory for at-home specimen collection for analysis solely at their own labs.

By Nick Paul Taylor • May 18, 2020

UnitedHealth, Microsoft launch COVID-19 screening app for employers

The healthcare behemoth said it will control employees' medical data and manage opt-in and consent requirements for users. The app will not provide tracking or contact tracing information.

By Rebecca Pifer • May 15, 2020

FDA revokes umbrella EUA for infusion pumps due to lack of industry use

The agency told medtechs it may instead grant individual EUAs for the devices going forward. B. Braun contends it is the only company with such an emergency authorization and is not affected by the revocation.   

By Greg Slabodkin • Updated Sept. 24, 2020

Abbott on defense as FDA flags false negative reports with point-of-care coronavirus test

An independent study circulated this week showed the rapid ID Now COVID-19 test could miss 48% of positive cases under some conditions. Abbott said late Thursday a backup test should be performed in certain cases.

By Nick Paul Taylor • May 15, 2020

Consumer COVID-19 fears, coverage concerns could stymie medtech rebound: Wall Street surveys

Some analysts say industry predictions on timing of a rebound in elective procedures may be too rosy.

By Maria Rachal • May 14, 2020

Philips, startups look to deploy new ultrasound tech amid coronavirus

The need for point-of-care imaging for lung and cardiac complications among COVID-19 patients has led to a flurry of expedited FDA reviews.

By Nick Paul Taylor • May 14, 2020

House Dems carve out $75B for coronavirus testing, contact tracing in bid for new relief package

The $3 trillion bill passed the House by a vote of 208-199 on Friday. It's Democrats' opening gambit for the next wave of congressional action, but Republicans say they're not in a hurry to approve new funding.

By Susan Kelly • Updated May 18, 2020

Eko algorithm gets FDA nod for cardiac screening of COVID-19 patients

Developed with the Mayo Clinic, Eko's algorithm gained breakthrough device status in December and review was further accelerated given its potential to identify patients at higher risk of poor outcomes with the coronavirus.

By Nick Paul Taylor • May 13, 2020

As Trump pushes states to reopen, Fauci warns against lifting COVID-19 restrictions too soon

The U.S. doesn't have the necessary testing and surveillance infrastructure in place to prep for a fall resurgence of the coronavirus, a second wave that's "entirely conceivable and possible," Fauci told a Senate panel.

By Rebecca Pifer • May 12, 2020

LabCorp at-home collection test kit for coronavirus goes mainstream, as states get $11B for testing efforts

The tests, originally only offered to frontline workers, are now available even to individuals without symptoms who may have been exposed to the virus. Still, clinical labs say more support is needed to further ramp up capacity.

By Greg Slabodkin • May 12, 2020

FDA, CDC drawing up plan to restart routine facility inspections

A phased approach is in the works to reintroduce certain oversight that's been on hold both domestically and internationally since the coronavirus outbreak reached pandemic level in March.

By Nick Paul Taylor • May 12, 2020