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

Zimmer posts $509M loss in Q1 as 80% of business faces COVID-19 hit

Like rivals, the medtech expects Q2 to bear the brunt of deferred procedures. But the pace of expected recovery thereafter is fluid and does not assume significant recurrence of the virus later this year, execs noted.

By Maria Rachal • May 11, 2020

Latest Abbott coronavirus antibody test receives FDA emergency use OK

The EUA is the company's second for a test detecting the IgG antibody, using a different machine than the first. Across both, it plans to ship almost 30 million units worldwide in May and double that amount in June. 

By Greg Slabodkin • May 11, 2020

1st antigen test to detect coronavirus gets FDA nod

The agency, which gave the green light on Saturday to Quidel, expects the tests to be cheaper to make than PCR tests.

By Nick Paul Taylor • May 11, 2020

Roundup: Q1 medtech reports give glimpse into coronavirus-era gains and losses

Much of the sector may be considered recession-proof — but it's not social distancing-proof. The last weeks of March previewed the dramatic trajectory of drops in routine testing and a mounting backlog of elective procedures.

By Maria Rachal • May 7, 2020

10 stories on the state of COVID-19 testing in the US

Despite medtechs' efforts to rapidly scale production of diagnostic and antibody tests, and commercial labs' work to make them more widely available, the U.S. still lacks adequate testing capacity, even as localities mull easing lockdowns. 

May 7, 2020

Telehealth is having a moment. What does its future look like after COVID-19?

Employers should expect workers to embrace telehealth post pandemic, sources told HR Dive, even if concerns about billing and security persist.

By Ryan Golden • May 7, 2020

BD says surgery revenues fell as much as 70% in April

As it faces pandemic headwinds, BD is also continuing to deal with problems with its Alaris infusion pump system and modules and expects to record a $200 million charge related to remediation efforts.

By Greg Slabodkin • May 7, 2020

FDA details COVID-19 era reporting rules to stymie medical device shortages

Under new powers granted by the CARES Act for the duration of the health crisis, the guidance to industry lays out when and how to notify the agency about changes that could affect product availability.

By Nick Paul Taylor • May 7, 2020

Qiagen aims for 50-fold jump in coronavirus test reagent output

The company, in the midst of being acquired by Thermo Fisher, reached capacity in April to support 7 million real-time PCR tests to detect the virus, with a target of 20 million per month by year’s end.  

By Nick Paul Taylor • May 7, 2020

Canceled surgeries drive hospitals to estimate $200B in losses in early months of coronavirus

The American Hospital Association's approximation counts the first four months of the pandemic, including a forecast through June. It comes as the lobby pushes for more aid on top of the $175 billion Congress has allocated so far.

By Ron Shinkman • May 6, 2020

Deferred elective procedures wipe out Smith & Nephew revenues, prompting $200M in cost cuts

The medtech's sales were nearly halved in April due to the pandemic, with its orthopaedics, sports medicine and wound management lines all experiencing drops in demand. The company is “not reducing headcount at this stage."

By Nick Paul Taylor • May 6, 2020

Oncology systems maker Varian ekes out sales gain amid procedure delays

The company managed a 2% uptick in Q2 revenues despite the slowdown in non-essential procedures as people postponed routine screenings, which in turn has delayed the start of treatment for new cancer patients.

By Susan Kelly • May 5, 2020

AHA, societies share new roadmap amid restarts to TAVR, other postponed procedures

As more U.S. states ease coronavirus-driven restrictions on elective medical care, North American cardiovascular groups laid out stages of safe reintroduction for invasive procedures and diagnostic imaging.

By Nick Paul Taylor • May 5, 2020

FDA beefs up coronavirus antibody test regs critics called 'recipe for disaster'

The Association of Public Health Laboratories praised the move. "This revised policy makes a lot of sense and should have been in place over the last six weeks," the group's CEO Scott Becker said.

By Greg Slabodkin • May 4, 2020

Respiratory muscle stimulator greenlighted by FDA for COVID-19 patients

In an attempt to more quickly free up sought-after ventilators and limit long-term health risks, the Liberate Medical device aims to provide therapy that reduces disuse atrophy of the abdominal wall muscles.

By Maria Rachal • May 4, 2020

7 states team up to buy $5B in ventilators, PPE to meet COVID-19 demand

New York, New Jersey, Connecticut, Pennsylvania, Delaware, Rhode Island and Massachusetts are aiming to use their combined purchasing power to drive down prices amid rivalry with other states and even the federal government.

By Rebecca Pifer • May 4, 2020

Ventilator sharing among states critical to save COVID-19 patient lives: Health Affairs paper

Without a coordinated federal effort to promote the exchange of the breathing assist machines, thousands more Americans will die in the coming weeks as the virus continues its rampage across the U.S., a new paper warns.

By Susan Kelly • May 4, 2020

Roche gets emergency OK for coronavirus antibody test

The diagnostics giant cited internal research that its product may be less likely to deliver false positives than some earlier-to-market serology tests, a concern regulators seek to address with a policy change Monday.

By Nick Paul Taylor • Updated May 4, 2020

CMS eases rules on COVID-19 diagnostics, antibody testing

A written practitioner’s order is no longer needed to obtain Medicare payment for diagnostic testing. The agency will also cover serology testing, including certain FDA-authorized tests for which patients collect samples at home.

By Hailey Mensik • May 1, 2020

Stryker sees 50% of revenue vulnerable to elective procedure pullback

Despite making it out of Q1 with total sales up 2%, the medtech's U.S. orthopaedics and spine sales dropped roughly 65% in April after a near total halt in non-essential procedures due to the coronavirus pandemic.

By Maria Rachal • May 1, 2020

Coronavirus surge in critical care sales helps Hillrom beat Q2 guidance

The company on Friday said it is hiring 300 additional staff globally to enable a fivefold increase in production of non-invasive ventilators, while doubling output of other products in high demand for COVID-19 patients. 

By Nick Paul Taylor • May 1, 2020

COVID-19 spurs 'incredible demand' for ventilators, buoying ResMed's 16% revenue uptick

CEO Mick Farrell told investors sales of breathing assist machines added $35 million in coronavirus-related revenue. However, sleep testing declined by double digits.

By Greg Slabodkin • May 1, 2020

Hologic to launch 2nd coronavirus test amid broader sales slide

The molecular diagnostics business posted its best growth rate in eight years, but the breast health and surgical segments slowed as a result of postponed elective surgeries.

By Susan Kelly • April 30, 2020