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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…

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…

The 18 most innovative medical devices of 2020

The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release. “The awards committee applauds the nominees for their commitment to ensure a healthier future for generations to come.”

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

The 18 most innovative medical devices of 2020

The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release. “The awards committee applauds the nominees for their commitment to ensure a healthier future for generations to come.”

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 th…

DTW podcast: Connect your devices before it’s too late

Twenty years ago when he was working at the Mayo Clinic, cardiologist Dr. David Hayes shot down the idea that medical devices would serve patients better if equipped with technology that collected and transmitted data.

Hayes had many reasons. He said patients liked coming to the doctors’ offices. “I thought they’d miss that connection,” he said. He worried that physicians would be overwhelmed with too much data. He had other objections, too, and he’s not afraid to admit it.

“You could just check them off one-by-one,” he said in this week’s DeviceTalks Weekly podcast. “I was wrong on every one.”

Now chief medical officer for Biotronik, Hayes came around years ago and is responsible for ensuring the medical device company keeps moving forward in incorporating technology that can connect patients with physicians and hospitals. Biotronik is among the growing number of medical device companies that are examining new potential for medtech connectivity.

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DTW podcast: Connect your devices before it’s too late

Twenty years ago when he was working at the Mayo Clinic, cardiologist Dr. David Hayes shot down the idea that medical devices would serve patients better if equipped with technology that collected and transmitted data.

Hayes had many reasons. He said patients liked coming to the doctors’ offices. “I thought they’d miss that connection,” he said. He worried that physicians would be overwhelmed with too much data. He had other objections, too, and he’s not afraid to admit it.

“You could just check them off one-by-one,” he said in this week’s DeviceTalks Weekly podcast. “I was wrong on every one.”

Now chief medical officer for Biotronik, Hayes came around years ago and is responsible for ensuring the medical device company keeps moving forward in incorporating technology that can connect patients with physicians and hospitals. Biotronik is among the growing number of medical device companies that are examining new potential for medtech connectivity.…

Medtech manufacturers must add warning label to drug-eluting PAD devices

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks.

A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials and discovered that there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices after 5 years and a 93% relative risk after 5 years compared to therapy with an uncoated balloon.

Labeling changes will apply to instructions for use of these devices throughout Europe and will include a warning and a summary of the Katsanos publication plus supplemented with the clinical data specific to each device. No device…

Acutus Medical, Biotronik ink deal

Acutus Medical and Biotronik have announced that they will collaborate on electrophysiology, mapping, ablation and accessory products across certain markets.

Under the agreement, Acutus expects to market a range of Biotronik EP ablation catheters and diagnostic/accessory products under a private label to most international markets. The companies believe they can create a secure digital network across cardiac rhythm management and electrophysiology mapping and ablation devices.

Get the full story on our sister site MassDevice.

Acutus Medical, Biotronik ink deal

Acutus Medical and Biotronik announced an alliance to collaborate on electrophysiology, mapping, ablation and accessory products across select markets.

The products involved in the collaboration center around the treatment of cardiac arrhythmias in markets that include Europe and Asia, according to a news release.

Acutus’ AcQMap system with SuperMap multi-mode mapping capabilities lies in the center of the new alliance between companies, as Acutus touts it as the only commercially available non-contact mapping system that can map stable and unstable rhythms. Those capabilities allow for electrophysiologists to see changes in conduction during a procedure, giving them a basis on which to customize therapy.

Under the agreement, Acutus expects to, under a private label, market a range of Biotronik EP ablation catheters and diagnostic/accessory products to most international markets with the goal to optimize care for arrhythmia patients with digitally-…

Biotronik touts results of CRT-DX study

Biotronik today touted results confirming that its two-lead CRT-DX system provides equivalent therapy compared to conventional three-lead systems.

The CRT-DX systems include a CRT-DX pulse generator and a DX implantable cardioverter-defibrillator (ICD) lead to provide atrial sensing and help reduce complications associated with an additional atrial lead for patients who do not need atrial pacing.

Results published in the Journal of Cardiovascular Electrophysiology showcased the outcomes from 240 patients across 50 centers in the U.S. The patients were selected to identify 120 matched pairs with similar demographic characteristics and had a minimum of six months of follow-up. The primary endpoint was the complication-free rate, with patients recording a mean follow-up time of approximately 1.4 years.

Lake Oswego, Ore.-based Biotronik observed that its CRT-DX system provided similar CRT (cardiac resynchronization therapy) responses and significantl…