Manufacturing

Abbott, Quest, Quidel scramble to add test capacity as delta variant surges

Quest Diagnostics is adding testing platforms in areas of the U.S. with high demand while manufacturers of at-home coronavirus tests such as Abbott and Quidel are ramping up capacity again after the early summer slump.

By Nick Paul Taylor • Sept. 03, 2021

Qiagen joins Abbott, Quidel cutting 2021 outlook as COVID-19 test demand wanes

CEO Thierry Bernard blamed a faster-than-expected testing drop and uptick of vaccinations. Jefferies said the downgraded targets are disappointing, particularly given management's forecast reiteration last month.

By Greg Slabodkin • July 13, 2021

Abbott lays off 400 workers amid drop in demand for COVID-19 tests

The company cut its 2021 outlook in June, blaming a sharp, rapid decline in demand for its coronavirus-related diagnostics on global vaccination efforts. The downward trend is anticipated to continue, an Abbott spokesperson said. 

By Greg Slabodkin • July 09, 2021

FDA seeks feedback on distinction between device remanufacturing and servicing

The long-awaited draft guidance is meant to clarify a blurry line between the two processes. The Medical Imaging and Technology Alliance contends remanufacturing is being done by unregulated third-party device servicers.

By Nick Paul Taylor • June 18, 2021

FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production

The Biden administration said its request for the Center for Devices and Radiological Health will help the U.S. reduce reliance on products from China and other countries and strengthen its ability to respond to emergencies.

By Nick Paul Taylor • June 01, 2021

Quidel shakes Wall Street with bearish COVID-19 test forecast

The company late Thursday pre-announced first-quarter revenue nearly $100 million below analyst expectations, with Craig-Hallum's Alex Nowak now calling the business unforecastable.

By Greg Slabodkin • April 23, 2021

Drugmakers flock to Vineti's fix for a cell, gene therapy problem

The San Francisco-based tech company wants to establish a patient identifier akin to a digital ID badge that could work for all types of advanced medicines and improve traceability, control costs and better ensure patient safety. 

By Jacob Bell • March 24, 2021

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.