The 24 best medical device innovations of 2022

The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards.

There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021.

The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.

Nominees need to be FDA-approved for the market within the last five years and show major potential to affect healthcare. The winners will be announced in October at the Prix Galien USA Awards in New York City.

This year, the foundation nominated 24 medical device innovations, 22 biotechnology products and 33 pharmaceutical agents. The devices range from an intraocular lens to a bariatric stapler.

“Every year, evaluating and recognizing the amazing submissions that come through for the Prix Galien Awards is one of the greatest honors,” said Dr. Sue Des…

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CVRx stock ticks up on Street-beating Q2 sales, raised guidance

CVRx (Nasdaq:CVRX) shares were up this morning on second-quarter results that beat the consensus revenue forecast.

The Minneapolis-based neuromodulation technology developer posted losses of $11.1 million, or 54¢ per share, on sales of just over $5 million for the three months ended June 30, 2022, for a more than $6 million bottom-line gain despite remaining in the red on sales growth of 61.1%.

CVRx’s losses per share of 54¢ fell in line with expectations on Wall Street, while the company’s revenues came in more than 6.8% ahead of analysts’ projections.

“I am very pleased with what we were able to accomplish in the second quarter. The adoption of Barostim continues to accelerate as we execute on our strategy to expand our sales force and leverage marketing initiatives to increase awareness while at the same time working with existing customers to help more patients,” CVRx President and CEO Nadim Yared said in a news release. “We anticip…

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CVRx launches new Barostim programmer in U.S.

CVRx (Nasdaq:CVRX) announced that it launched its new Barostim programmer following its approval by the FDA earlier this year.

Minneapolis-based CVRx designed its second-generation programmer to operate on an upgraded cellular network to enable remote view access. It also includes an improved user interface that simplifies implantable pulse generator (IPG) programming.

According to a news release, the new Barostim programmer has compatibility with the entire portfolio of Barostim implantable systems.

The company plans to commence a complete rollout of the Barostim programmer across the U.S. market throughout 2022.

“The new Barostim Programmer builds upon the earlier model and includes significant enhancements to both hardware and software,” President and CEO Nadim Yared said in the release. “This upgrade allows CVRx to continue to provide superior customer support and reflects our commitment to innovating across all aspects of Ba…

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FDA approves magnetic resonance labeling for CVRx’s Barostim neuromodulation system

CVRx’s Barostim Neo [Image courtesy of CVRx]CVRx (Nasdaq:CVRX) announced today that the FDA approved magnetic resonance (MR) conditional labeling for its Barostim system.

The Barostim neuromodulation system for treating the symptoms of heart failure now includes instructions to allow for safe MRI scans of the head and lower extremities, offering heart failure patients implanted with Barostim more diagnostic options.

Minneapolis-based CVRx said in a news release that all Barostim patients, including those already receiving Barostim therapy, can now safely receive an MRI at 1.5T when conditions of use are met.

CVRx designed the Barostim system to stimulate baroreceptors, reducing the heart’s workload and helping it to pump more efficiently to improve the symptoms for heart failure patients. Studies have shown those implanted with Barostim were able to walk further in a six-minute hall walk test, have a higher quality of life and they appeared to h…

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CVRx misses in Q4, wins FDA approval for new IPG

CVRx’s Barostim Neo [Image courtesy of CVRx]CVRx (NSDQ:CVRX) posted fourth-quarter results today that fell short of the consensus forecast on Wall Street and offered its outlook for the year ahead.

The Brooklyn Park, Minnesota-based neuromodulation implant developer reported a loss of $10.57 million, or $0.52 per diluted share, on sales of $3.7 million for the three months ended Dec. 31, 2021, for a bottom-line loss of 210% and sales growth of 75% compared with Q4 2020.

The loss was $0.08 per share deeper than expected by the Street, where analysts were looking for EPS of -$0.44 on sales of $3.86 million.

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

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CVRx misses in Q4, wins FDA approval for new IPG

Barostim Neo [Image from CVRx]

CVRx (NSDQ:CVRX) posted fourth-quarter results today that fell short of the consensus forecast on Wall Street and offered its outlook for the year ahead.

The Brooklyn Park, Minnesota-based neuromodulation implant developer reported a loss of $10.57 million, or $0.52 per diluted share, on sales of $3.7 million for the three months ended Dec. 31, 2021, for a bottom-line loss of 210% and sales growth of 75% compared with Q4 2020.

The loss was $0.08 per share deeper than expected by the Street, where analysts were looking for EPS of -$0.44 on sales of $3.86 million.

Full-year revenue climbed to $13 million, a 115 percent increase over the year before, but just short of the company’s projection after the third quarter.

The company lost nearly $43.1 million in 2021, compared to a $14.1 million loss in 2020. Significant costs included $27.9 million for selling,…

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The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news release.

Nominees need to be FDA-approved for the market within the last five years a…

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The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]

The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news releas…

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CVRx CEO Nadim Yared suggests steps toward improving diversity and equality

Nadim Yared, CEO of CVRx

In this week’s episode of DeviceTalks Weekly, we follow up with last week’s guest, Nadim Yared, CEO of CVRx, to catch up on how the medtech executive is managing during the pandemic.

Yared also shares some far-reaching views on what the medtech industry needs to work toward to improve diversity in its workforce and provide equality for society.

We also visit with Mira Sahney, CEO of Hyalex Orthopaedics, one of medtech’s most interesting startups. Hyalex was identified as a notable startup in the recent report in Medical Design and Outsourcing. In this interview, Sahney reveals Hyalex’ origins, the state of its potential cartilage replacement product, and why start-ups have a natural advantage operating in a pandemic.

Don’t miss an episode! Subscribe to DeviceTalks Weekly on your podcast players.

DeviceTalks by MassDevice · CVRx Nadim Yared on COVID-19, diver…
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