Medical Design and Outsourcing Archives - Page 104 of 154

How medtech fared in the first waves of the pandemic

[Photo by Martin Sanchez on Unsplash]

Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data.

Total sales, R&D spending and employment for the world’s largest medical device companies declined in 2020 and early 2021, according to a Medical Design & Outsourcing analysis tallying the ongoing pandemic’s initial toll on the industry.

To compare performance before and during the pandemic, MDO used the financial data that we’ve historically gathered to rank our Big 100 companies in the last three years. The majority of these companies reported full-year results for 2020; others operate on a fiscal year and reported annual results in the first half of 2021.

Some companies are not in this year’s Big 100 but were included in the analysis because they were ranked in pre…

FreeStyle Libre 3, other Abbott products recognized at CES Innovation Awards

The sensor for the next-generation FreeStyle Libre 3 CGM is the same size as two pennies stacked together. [Image courtesy of Abbott]

Abbott (NYSE:ABT) was honored for a handful of its offerings at the Consumer Electronics Show (CES) 2022 Innovation Awards.

The company’s FreeStyle Libre 3 continuous glucose monitoring (CGM) system ranked among the top 15 products in the CES Best of Innovation category. The next-generation CGM system features the world’s smallest, thinnest glucose sensor that can be worn up to 14 days to deliver continuous, real-time glucose readings directly to smartphones.

Get the full story on our sister site, MassDevice.

Evonik launches new Resomer PrintPowder polymers for 3D printing of personalized, implantable medical devices

Evonik’s Resome PrintPowder is used for 3D printing medical devices and implants. [Photo courtesy of Evonik]

Evonik has launched the second generation of Resomer PrintPowder polymers for 3D printing of personalized, implantable medical devices.

Essen, Germany-based Evokik said the powders have a broader range of customizable mechanical properties and degradation rates, allowing their use for more complex and tailored medical devices including orthopedic, dental, or soft tissue applications.

“These new powders will allow manufacturers to create personalized devices with complex internal designs that match a patient’s anatomy — this will open up new treatment options for patients,” Thomas Riermeier, head of Evonik’s Health Care business line, said in a news release.

Evonik also offers comprehensive selective laser sintering (SLS) application and printing service support for the new powde…

FDA says Philips knew about toxic foam for years before massive recall

The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices.

The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway, causing health problems for users.

In the Form 483, FDA alerted management at the Royal Philips (NYSE:PHG) subsidiary of conditions that the inspector considered possible violations of the U.S. Food, Drug and Cosmetic Act or related regulations. The post-inspection report is not a determination of wrongdoing and will be considered by the FDA along with any evidence or documents collected from the facility and responses offered by Philips. (Le…

Resonetics buys Hudson Medical Innovations

Resonetics said today that it has purchased Hudson Medical Innovations from Preco.

Hudson manufactures microfluidics, point-of-care diagnostics (including application of reagents), biosensors, and advanced wound care devices. The company was founded in 2012 and is headquartered in Hudson, Wisconsin.

Resonetics said Hudson’s responsive prototyping capabilities and proprietary, automated equipment helped build its reputation as a supplier that supports customers with precise products from development to high-volume production.

“Hudson Medical Innovations is utilizing many of the same principles that have driven Resonetics’ growth: a focus on the customer, innovative problem solving, and purpose-built equipment to scale production efficiently,” Resonetics President and CEO Tom Burns said in a news release. “The Hudson team has established a great position serving leading customers in very exciting high-growth markets, expanding the breadth and diversi…

FDA requests safety testing of replacement foam in Philips sleep devices recall

The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them.

The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based polyurethane (PE-PUR) sound abatement foam that broke down, allowing foam and chemicals to potentially enter the device’s air pathway and cause health problems for users.

On Friday, the FDA said that upon inspection of a Philips Respironics manufacturing facility used to make replacement foam for the recalled devices, it learned that the silicon-based product failed a safety test for the release of volatile organic compounds (VOCs). That test was conducted on a similar device sold outside the U.S.

“The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and rep…

7 diabetes treatment innovations to look out for on World Diabetes Day

World Diabetes Day — Nov. 14 — centers around raising awareness for those with diabetes.

This year, that aim remains the same, and medical technology companies continue to look for ways to continue improving the management of the metabolic disease.

Some of those treatments involve insulin, which was discovered as a treatment for diabetes in 1922 and remains a vital part of the standard of care. World Diabetes Day falls on Nov. 14 because it is the birthday of Frederick Banting, one of the scientists involved in discovering insulin as a treatment for diabetes.

However, while many medtech companies look for ways to make insulin accessible and efficient in treating diabetes, others are innovating treatment avenues outside of insulin. Regardless of the path chosen, all have created intriguing options for managing and treating diabetes. Here are seven innovations in diabetes treatment that are worth keeping an eye on:

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TIME recognizes Abbott among this year’s 100 best inventions

The BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]

Abbott (NYSE:ABT) was among a series of medtech companies to receive recognition from TIME in its list of 2021’s best inventions.

The list of the year’s top inventions included Abbott’s innovations twice, with a nod to its NeuroSphere Virtual Clinic and its at-home COVID-19 testing offerings.

NeuroSphere Virtual Clinic allows physicians to speak to patients over a video app and to remotely adjust Abbott’s implanted neuromodulation devices. The platform won FDA approval in March and Time reported that the company plans to expand availability of NeuroSphere Virtual Clinic soon.

Abbott’s BinaxNOW was one of several at-home, over-the-counter COVID-19 tests to receive a mention from Time as the news organization recognized the tests for aiding in efforts to prevent the spread of the virus.

In a post on LinkedI…

The 100 largest medical device companies in the world

Nearly half a trillion dollars — $421 billion to be exact — that’s how much the world’s 100 largest medical device companies brought in over the past year amid the COVID-19 pandemic.

That’s one of the big takeaways from the Big 100, MassDevice and Medical Design & Outsourcing‘s annual analysis of the worlds’ 100 largest medtech companies. (Check out the full Big 100 rankings here.)

Aggregate revenue for approximately 100 of the largest medical technology companies dropped 1.2% in 2020 compared to 2019. But that’s not bad considering that the worst pandemic in a century was taking place, sparking a global recession in its wake.

Some medtech businesses that played critical roles fighting the pandemic — such as 3M’s Health Care segment and Hologic — even saw revenues increase and rose in the Big 100 rankings as a result.

Check out the full Big 100 rankings here>>

CMS puts final nail in MCIT payment proposal for breakthrough devices

The U.S. Centers for Medicare & Medicaid Services (CMS) rescinded the Medicare Coverage of Innovative Technology (MCIT) and definition of “Reasonable and Necessary” final rule today.

CMS said it intends to explore ways to improve the coverage process for better access to innovative and beneficial medical devices, including a process for the Medicare program to cover new technologies based on scientifically sound clinical evidence and health and safety protections.

“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” CMS Administrator Chiquita Brooks-LaSure said in a news release. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”

The rule would have authorized government payments for medical devices designated as breakthroughs…

What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains

Jason Weidman is a Medtronic SVP and president of its coronary and renal denervation business. [Photo courtesy of Medtronic]

As Medtronic (NYSE:MDT) continues clinical trials of its Symplicity Spyral renal denervation (RDN) system for treating hypertension, the Fridley, Minnesota-based medical device maker now hopes to win FDA approval in 2023.

To better understand the technology behind what Medtronic leaders expect to become a multibillion-dollar business, Medical Design & Outsourcing spoke with Jason Weidman, Medtronic senior vice president and president of the coronary and renal denervation business, which is part of Medtronic’s cardiovascular portfolio. (We’ve edited this conversation for brevity and clarity.)

MDO: What’s the simplest way to explain renal denervation?

Weidman: The basic idea is that your kidneys are part of the body’s blood pressure control mechanis…

Biden says he’ll nominate Robert Califf as FDA commissioner

Former FDA commissioner Dr. Robert Califf could return to his old job if President Joe Biden has his way.

Biden today announced his intention to nominate Califf to serve as FDA commissioner — a job he previously held during the Obama administration from 2016-17.

A cardiology professor at Duke University and a member of the Duke Clinical Research Institute, Califf is also head of clinical policy at Google’s Alphabet sister company Verily Life Sciences.

Get the full story on our sister site MassDevice.