Manufacturing

Quidel mulls entering new COVID-19 testing markets after another bumper quarter

The point-of-care diagnostics maker sold $678.7 million in kits in the fourth quarter, up 81% sequentially, and is assessing whether it has the capacity to support antigen tests for retail, travel, entertainment and sports. 

By Nick Paul Taylor • Feb. 19, 2021

DoD awards Ellume $231M to increase US production of at-home, OTC COVID-19 test

The Australian diagnostics company will use the funding to establish a U.S. manufacturing facility that is projected to increase production capacity by 640,000 tests per day by December.

By Susan Kelly • Feb. 02, 2021

4 key trends for medtech in 2021

With resurgence of the coronavirus and emergence of more contagious strains, COVID-19 challenges, but also opportunities, lie ahead for medical device and diagnostics companies.

By Greg Slabodkin • Jan. 29, 2021

Dive Awards

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. 09, 2020

Dive Awards

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. 09, 2020

Dive Awards

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. 09, 2020

Medical device makers get more flexibility with value-based care in Stark, anti-kickback final rules

The changes include two safe harbor pathways and "allow you to do things that otherwise might violate the kickback statute or the Stark Law. So, that is always welcome in the industry," one lawyer said.

By Ricky Zipp • Nov. 24, 2020

Boston Scientific calls it quits on Lotus Edge TAVR program

Shares fell 10% after a voluntary recall led Boston Scientific to end the product line entirely. The surprise move gives Medtronic and Edwards Lifesciences the opportunity to gain back ground in the near term.

By Maria Rachal • UPDATED: Nov. 17, 2020 at 11:16 a.m.

3 ways Biden's COVID-19 approach could impact medtech

A new administration — regardless of who's in power — means device makers can anticipate shifts at key government agencies like the FDA.

By Maria Rachal , Greg Slabodkin • Nov. 12, 2020

Abbott device growth returns as Wall Street queries staying power of COVID-19 test boom

CEO Robert Ford argued that focusing on how coronavirus test demand will evolve "misses the point," touting the longer-term benefits of its now-expanded diagnostic platforms footprint.

By Maria Rachal • Oct. 21, 2020

FDA finalizes guidance on nitinol devices, posts biocompatibility draft

The agency has been looking at the alloy, commonly used in stents and heart valves, as part of a broader look at metals that can cause inflammatory or other types of reactions once inside the body.

By Nick Paul Taylor • Oct. 15, 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. 01, 2020

FEMA pitches voluntary DPA pact to bolster medical supply chain during pandemic

The Defense Production Act allows private companies to enter agreements with the government while avoiding antitrust liability. AdvaMed wants to participate but FEMA has not yet extended an invite.

By Greg Slabodkin • Aug. 18, 2020

Sponsored by Accenture

COVID-19: Leading with agility and responsible innovation in MedTech

MedTech companies can take swift action to help solve for the COVID-19 crisis with a mindset of responsible innovation and emerge stronger than before. 

By Maximilian Schmid, Thomas E. Kawalec, Debmalya Chatterjee, Tunc Yorulmaz, Florian Schulz, William de Waard & Sanskriti Thakur • Aug. 17, 2020

Coronavirus muddies FDA's trajectory on device warning letters

An agency official said going into 2020 that its devices center would be better equipped to use the compliance tool in a timely fashion. But a dry spell for on-site surveillance may undermine any noticeable rebound.

By Maria Rachal • UPDATED: Aug. 12, 2020 at 10:17 a.m.

House panel asks IG to investigate Trump admin bungling of Philips ventilator deal

The Subcommittee on Economic and Consumer Policy on Thursday sent a letter to the acting inspector general requesting a probe into findings that HHS overpaid by $500 million in a contract negotiated with the Dutch medtech. 

By Susan Kelly • UPDATED: Aug. 7, 2020 at 11:06 a.m.

Quidel says COVID-19 antigen test buoys 270% rise in rapid diagnostics unit, demand 'more than we can satisfy'

The company late Thursday reported second quarter total sales of $201.8 million, an 86% increase over the prior year, with strong demand for its PCR and antigen tests for the coronavirus.

By Greg Slabodkin • UPDATED: July 31, 2020 at 1:28 p.m.

Medtech and COVID-19: 6 months into the public health emergency

MedTech Dive examines where the industry stands with testing and the future of those emergency use-authorized diagnostics, as well as how it's adapting to a rebound in elective surgeries and various supply chain challenges.

How COVID-19 is challenging and changing medtech supply chain management

Four experts share insights on the supply and demand hangups medtechs have been working through during the pandemic, and a few early takeaways the industry can carry forward.

By Maria Rachal • July 27, 2020

Diagnostics makers must plan for EUA products to have post-pandemic future

An extension to the public health emergency formalized a reprieve for emergency use authorizations, but manufacturers should act now if they want products to stay on the market when the crisis ends, compliance experts say.

By Greg Slabodkin • July 27, 2020

An insider's look at how GM, Ventec ramped up ventilator production amid COVID-19

The weight of the Defense Production Act was key in opening doors, said the CEO of the engineering firm contracted to test each of the 30,000 devices expected under the agreement.

By Greg Slabodkin • July 13, 2020

FDA plans to restart domestic inspections, contingent on local coronavirus trends

The agency is aiming to resume some on-site surveillance the week of July 20 after shutting down non-critical inspections in March due to the COVID-19 outbreak.

By Maria Rachal • July 10, 2020

Lab groups ask Trump admin for more transparency into COVID-19 testing supply allocation

Eight organizations representing laboratory professionals asked the White House Coronavirus Task Force to address ongoing obstacles to performing tests.

By Greg Slabodkin • July 10, 2020

Cue Health raises $100M to scale up rapid, portable coronavirus test

The startup, which counts J&J among its backers, said on Friday it received FDA emergency use authorization for its test, allowing use anywhere under the supervision of qualified medical personnel. 

By Nick Paul Taylor • UPDATED: June 12, 2020 at 11:37 a.m.

Fitbit, NASA get latest FDA emergency authorizations for ventilators

Fitbit's invention is considered an emergency resuscitator, the same label given to a device manufactured by Boston Scientific. NASA's breathing machine builds on a version of a full-fledged ventilator that gained FDA's OK in April.  

By Nick Paul Taylor • June 03, 2020