Manufacturing: Page 2

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

Baxter cites 'extraordinary' Q1 demand from customers fighting coronavirus

Revenues grew 6% to $2.8 billion thanks to growth across all six of the company's global business units and three geographic segments.

By Greg Slabodkin • April 30, 2020

Medtronic sees US business fall 60% amid pandemic response

The subset of devices suddenly seeing higher demand are mostly low-margin businesses, leading the medtech giant to brace investors for a hit to earnings during next month's quarterly report.​

By Maria Rachal • April 22, 2020

ResMed to get biggest bang out of HHS ventilator contracts, analysts predict

Medtronic and Hillrom may see limited gains from their smaller deals, but ​ResMed’s contract could add a 2.7% bump to growth in the fourth quarter, Needham analysts noted.

By Nick Paul Taylor • April 21, 2020

GE, Ford get $336M HHS contract for 50K lower-cost ventilators

The latest deal works out to about $6,720 per ventilator. GE's roughly $64 million contract for 2,410 ventilators detailed earlier this week works out to a little more than $26,000 per device. 

By Nick Paul Taylor • April 17, 2020

Philips launches scaled-down ventilator, inks production deals to boost output

The medtech has allied with smaller players Flex and Jabil with a goal of 4,000 units per week by the third quarter and is also rolling out an alternative to its full-featured critical care breathing devices amid the coronavirus pandemic.

By Nick Paul Taylor • April 15, 2020

GE, Medtronic, ResMed among 7 medtechs part of $1.4B in finalized HHS ventilator contracts

Building on more than $1.1 billion announced for GM and Philips last week, the latest batch of contracts are aimed at producing over 64,000 of the potentially life-saving devices for COVID-19 patients.

By Maria Rachal • April 14, 2020

The latest coronavirus shortage: hospital infusion pumps

A surge in COVID-19 cases is not only straining the supply of the devices that administer medications and fluids, but the potentially risky tubing that allows them to be situated in hallways to create distance from sick patients' rooms.

By Greg Slabodkin • April 14, 2020

Industry cheers COVID-19 executive order to boost ventilator supply chain

While AdvaMed has pushed back on using the Defense Production Act, the move is meant to help domestic manufacturers by removing hurdles to accessing parts and materials needed to ramp up production of ventilators.

By Greg Slabodkin • April 03, 2020

Medtechs navigate new normal as FDA shifts priorities to coronavirus

Companies are working to get diagnostics, respiratory devices and PPE to market amid rapidly evolving guidance from FDA. The agency's coronavirus-era operations may also impact work for device makers in other parts of the sector.

By Maria Rachal • April 03, 2020

FDA outlines role for 3D printing in coronavirus response, with some caution

Additive manufacturing has emerged as a tool to help bolster availability of critical devices like ventilators and testing supplies, but the agency said 3D-printed personal protective equipment may not be as effective.

By Nick Paul Taylor • March 27, 2020

How health systems are responding as COVID-19 squeezes the medical supply chain

Procurement of supplies will become more difficult if cases surge and federal stockpiles don't trickle down to the state level quickly enough.

By Deborah Abrams Kaplan • March 25, 2020

Tracking the impact of coronavirus on the medtech industry

Among the latest: As COVID-19 test sales boom, Hologic thinks its revenues this quarter may be 60% higher than last year's.

By Nami Sumida • UPDATED: Sept. 11, 2020 at 10:15 a.m.