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10 women medtech leaders you should know
There is a women’s leadership gap in the U.S., and women in medtech have been working to alleviate that problem. According to a report from the Centers for American Progress, women hold 52% of...
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Why partnerships between medtech companies and doctors are so important
Laura Dietch, CEO of BioTrace Medical [Image from BioTrace Medical]As new devices and technologies are being developed in the medtech industry, doctors and physicians have to learn about the devices on...
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Abiomed wins FDA nod for Impella CP with SmartAssist, taps Trapp as CFO
Abiomed (NSDQ:ABMD) said today it won FDA pre-market approval for its next-gen Impella CP heart pump with the SmartAssist optical sensor, and announced late last week that it named Todd Trapp its new...
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CorWave wins $4m from French Innovation Challenge
CorWave said today it was awarded approximately $3.5 million from France’s Worldwide Innovation Challenge, financed by BpiFrance’s Invest for The Future Program. France-based CorWave said it received...
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Abiomed wins CE Mark for Impella 5.5
Abiomed (NSDQ:ABMD) said today that it won CE Mark approval in the European Union for its Impella 5.5 heart pump, saying that the first patient in Europe has already been treated with the device. The...
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FDA to launch ICD registry, update GUDID system
The FDA is slated to launch a new national registry of implantable cardiac defibrillators, according to a report from the Regulatory Affairs Professionals Society. The move comes after some reluctance...
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Murj launches OnSite cardiac device management workflow platform
Murj said today it launched the OnSite cloud-based in-office cardiac device management workflow platform. The OnSite software is an extension of the company’s remote transmission management workflow...
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Abbott releases cybersecurity, battery update for high-voltage implantable...
Abbott (NYSE:ABT) today announced a firmware upgrade for its high-voltage implantable cardiac devices looking to shore up cybersecurity and improve battery performance. The company stated that while...
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Biotronik inks distro deal with Aziyo for CanGaroo cardiac device envelope
Biotronik inked a US-based co-distribution deal with Aziyo Biologics to distribute the company’s CanGaroo bio-envelopes designed to hold cardiovascular implantable devices, according to a release from...
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Medtronic touts Micra leadless pacer post-approval registry study data
Medtronic (NYSE:MDT) today released one-year results from the post-approval registry study of its Micra leadless transcatheter pacing system, touting a high implant success rate and a low complication...
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Medtronic touts improved patient survival in AdaptivCRT algorithm study
Medtronic (NYSE:MDT) today released results from a study of its AdaptivCRT algorithm, touting that the use of the algorithm increased patient survival. Results from the trial were presented last week...
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Medtronic touts data from Micra pacer AV algorithm study
Medtronic (NYSE:MDT) late last week released data from a new clinical study of an algorithm used with its Micra transcatheter pacing system, touting that it has the potential to restore...
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FDA labels Medtronic Heartware recall as Class I
The FDA last Friday labeled a Medtronic (NYSE:MDT) voluntary select recall of its HeartWare HVAD systems over issues with unexpected power source switching as a Class I recall. A Class I recall is the...
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FDA labels IABP recall for Getinge’s Maquet, Datascope as Class I
The FDA today labeled a select recall of Getinge‘s (PINK:GETI B) Datascope and Maquet Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion as Class I. A...
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Medtronic warns on external pacemaker issues
Medtronic (NYSE:MDT) has released an urgent field safety notice warning of issues with a subset of its model 53401 single chamber external pacemakers in which the device may experience an unexpected...
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Stealthy NuPulseCV lands $4.5m for intravascular ventricular assist system
Stealthy NuPulseCV last week reported a funding round worth nearly $4.5 million for the intravascular ventricular assist system it’s developing. Raleigh, N.C.-based NuPulseCV said the equity offering,...
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Study: Leadless pacers lead to less complications
Patients who’ve received leadless pacemakers experience fewer complications than traditional pacers, according to a new study from the Cleveland Clinic. Results from the study were published in the...
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CorWave raises $17m for next-gen LVAD program
CorWave said today that it has raised approximately $16.5 million (EU €14 million) to help support the Calypso R&D program it is running to develop its Neptune cardiac assistance pump into a left...
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Thousands of Medtronic CRM devices need software upgrades
The FDA this week released notices from Medtronic (NYSE:MDT) warning of software issues with approximately 41,000 cardiac rhythm management devices. The warnings affect approximately 29,000 EnTrust...
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Medtronic wins expanded FDA nod for SelectSure pacing leads
Medtronic (NYSE:MDT) said today it won expanded FDA labeling for its SelectSecure MRI SureScan model 3830 cardiac pacing leads, now approved for His-bundle pacing. The Fridley, Minn.-based company...
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