Manufacturing

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

Deep Dive

How tariffs ravaged the COVID-19 medical supply chain

Months into the pandemic, the U.S. faces an ongoing shortage of PPE, with some of those products still subject to tariffs.

By Deborah Abrams Kaplan • May 29, 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

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 at 7:20 a.m.

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

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

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 07, 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 07, 2020