How medical device makers companies are responding to abortion bans

The front of U.S. Supreme Court in Washington, D.C. (Adobe stock photo)

Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access.

Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately.

Some medtech companies are not using the word “abortion” in their statements to news media.

Here is what we’re finding out at MassDevice and Medical Design & Outsourcing:

Medtronic

“As a healthcare company, we are committed to ensuring access to quality healthcare, and that starts first and foremost with our people. We are expanding our benefits policies to enable access to critical healthcare services for our U.S. employees. The new benefit will allow for reimbursement of travel, relocation, and legal expenses and …

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Medtronic appoints Pfizer EVP as independent board director

Lidia Fonseca is EVP and chief digital and technology officer at Pfizer [Image courtesy of Fonseca]

Medtronic (NYSE:MDT) announced today that it appointed Lidia Fonseca to its board of directors as an independent director.

Fonseca, who serves as EVP and chief digital and technology officer at Pfizer, will become a director effective today. She will serve on the board’s Compensation Committee and Science and Technology Committee.

Get the full story on our sister site MassDevice. 

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Medtronic appoints Lidia Fonseca as independent board director

Medtronic (NYSE:MDT) announced today that it appointed Lidia Fonseca to its board of directors as an independent director.

Fonseca, who serves as VP and chief digital and technology officer at Pfizer, will become a director effective today. She will serve on the board’s Compensation Committee and Science and Technology Committee.

“We are thrilled to welcome Lidia to Medtronic’s board of directors,” Medtronic Chair and CEO Geoff Marth said in a news release. “She has an impressive history of developing digital healthcare solutions that deliver powerful insights to improve patients’ lives. Her extensive knowledge and expertise will provide the Board with an important dimension and a tremendously valuable perspective as we drive toward our bold ambition to become the global leader in healthcare technology.”

With more than 30 years of experience in healthcare innovation, Fonseca currently holds responsibility for dev…

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They said it at DeviceTalks Boston

Proximie CEO Nadine Hachach-Haram [Photo courtesy of Proximie]Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead.

Here are some of the most quotable insights from panelists and speakers at our live event.

And make sure to save the date — and save your seat — for DeviceTalks West in Santa Clara, California on Oct. 19 and 20.

Get the full story at our sister site, Medical Design & Outsourcing.

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They said it at DeviceTalks Boston

Proximie CEO Nadine Hachach-Haram [Photo courtesy of Proximie]

Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead.

Here are some of the most quotable insights from panelists and speakers at our live event.

And make sure to save the date — and save your seat — for DeviceTalks West in Santa Clara, California on Oct. 19 and 20.

Read on to hear what medtech leaders had to say at DeviceTalks Boston 2022.

Next >>

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Another Medtronic HVAD recall is serious

Medtronic’s HVAD [Image courtesy of Medtronic]

A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving HeartWare Ventricular Assist Device pumps still implanted in patients.

The FDA today designated a Medtronic recall involving the HVADs as Class I, the most serious level. It’s the second Class I recall designation for the HVADs this month.

This time around, the Class I recall involves a potential welding defect affecting a specific lot of external batteries for the HVADs. Medtronic became aware of complaints that the battery had stopped providing power or failed to hold a charge. The medtech giant is retrieving the affected lot of batteries and replacing them.

“The wellbeing and experiences of patients implanted with the HVAD pump are vitally important to us. Although Medtronic no longer distributes the HVAD System, we are committed to…

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Another Medtronic HVAD recall is serious

Medtronic’s HVAD [Image courtesy of Medtronic]A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving its HeartWare Ventricular Assist Device pumps still implanted in patients.

The FDA today designated a Medtronic recall involving the HVADs as Class I — its most serious level. It’s the second Class I recall designation for the HVADs this month.

This time around, the Class I recall involves a potential welding defect affecting a specific lot of external batteries for the HVADs. Medtronic became aware of complaints that the battery had stopped providing power or failed to hold a charge. The medtech giant is retrieving the affected lot of batteries and replacing them.

“The wellbeing and experiences of patients implanted with the HVAD pump are vitally important to us. Although Medtronic no longer distributes the HVAD System, we are committed to ongoing quality assessments and control measures to furt…

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FDA clears Medtronic’s ligament augmentation system for spine surgery

[Image from Medtronic]Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance and breakthrough device designation for its LigaPASS 2.0.

According to a news release, LigaPass is the first and only FDA-cleared device with an indication for ligament augmentation in spine surgery.

The company designed the LigaPASS 2.0 ligament augmentation system due to its positive impact on proximal junctional kyphosis (PJK), a common post-operative complication with adult spinal deformity surgery that can lead to the development of the more severe form, proximal junctional failure (PJF).

“The surgical treatment of adult spinal deformity provides significant clinical benefit to patients but unfortunately many require revision due to early mechanical failure. The most common cause of mechanical failure is proximal junctional kyphosis,” UCSF Medical Center director of spinal tumor and spinal deformity surgery Dr. Christopher Ames said in the release. “F…

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Medtronic supply chain chief Greg Smith on shortages, suppliers and strategy

Greg Smith is Medtronic’s EVP of global operations and supply chain. [Photo courtesy of Medtronic]

The heat is on for Medtronic’s global operations and supply chain leader as he forges new links with suppliers the company relies on for innovation, quality and reliability.

For much of his 36-year career in operations, Greg Smith has had to explain to family and friends what the supply chain is and what his job is all about.

“I don’t have to do that anymore,” he said.

It’s no wonder why. Examples of supply chain SNAFUs have intruded on nearly all aspects of our everyday lives since the start of the COVID-19 pandemic, from shortages of masks, test components and toilet paper in the early days to persistent bottlenecks in semiconductors, resins and the many medical and consumer products that use them.

Smith is EVP of global operations and supply chain at Medtron…

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Medtronic issues another Class I recall for HVAD pump implants

Medtronic is recalling HVAD pumps for weld defects that could cause serious injury or death. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death.

The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 serious recalls for the Medtronic devices since 2014.

Fridley, Minnesota–based Medtronic halted sales and new device implantations in a Class I recall a year ago following complaints that the internal pump may fail or delay to restart.

Medtronic identified the new problem with pump weld defects this spring while investigating suspected cases of pump thrombosis in three patients, two of which died after their heart pumps were exchanged.

Get the full story at our sister site, Medical Design & Outsourcing.

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Medtronic issues another Class I recall for HVAD pump implants

Medtronic is recalling HVAD pumps for weld defects that could cause serious injury or death. [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death.

The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 serious recalls for the Medtronic devices since 2014.

Fridley, Minnesota–based Medtronic halted sales and new device implantations in a Class I recall a year ago following complaints that the internal pump may fail or delay to restart.

Medtronic identified the new problem with pump weld defects this spring while investigating suspected cases of pump thrombosis in three patients, two of which died after their heart pumps were exchanged.

“Following an ins…

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The biggest stories from the American Diabetes Association (ADA) 2022 Scientific Sessions

For the 82nd time, the American Diabetes Association (ADA) Scientific Sessions convened to highlight all the innovations within the diabetes technology space.

Major players like Dexcom, Medtronic, Abbott and more continue to plug along, while companies like Bigfoot Biomedical, One Drop and others shared data backing the technology that they bring to the table.

The data showcased at ADA supported the usual continuous glucose monitoring (CGM) and automated insulin delivery (AID) technology, plus different digital health platforms and diabetes reversal procedures.

BTIG analyst Marie Thibault wrote in a report that there was plenty of buzz on the ground at the event, particularly around Insulet’s Omnipod 5 AID system, Abbott’s recently FDA-cleared FreeStyle Libre 3 CGM and Bigfoot Biomedical’s Bigfoot Unity platform.

“In general, we believe that accuracy and clinical benefit is proven for all commercial CGM and AID offerings an…

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