Cardiology FDA Approved

Spry Health Continuous Wrist-Worn Pulse Oximeter, Heart and Lung Meter FDA Cleared

Released on April 16, 2019

Spry Health, a Silicon Valley company, won FDA clearance to introduce its…

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Cardiology FDA Approved

LIFEPAK CR2 Defibrillator Reads ECG During Chest Compressions, FDA Approved

Released on April 15, 2019

Stryker won FDA approval to introduce its LIFEPAK CR2 defibrillator with LIFELINKcentral program manager…

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Cardiology

Biotronik Is a Tougher Competitor in Stents with PK Papyrus

Released on April 12, 2019

Biotronik’s PK Papyrus might be paper thin – but …

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Cardiology Public Offering

BioCardia registers for $18m offering

Released on April 10, 2019

BioCardia (NSDQ:BCDA) has registered for an upcoming offering of its common stock, looking to raise…

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Cardiology Surgery Vascular

BIOTRONIK Releases Carnelian Support Catheter to Help Treat Difficult Peripheral Lesions

Released on April 10, 2019

BIOTRONIK is releasing a new device specifically designed for…

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Cardiology

Biotronik launches PK Papyrus covered coronary stent

Released on April 10, 2019

Biotronik said today that it’s launching the PK Papyrus covered coronary stent system…

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Cardiology FDA Approved

Avinger wins FDA nod for Pantheris SV small vessel atherectomy device

Released on April 10, 2019

Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its…

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Cardiology Imaging

Vector Flow Imaging Used to See Blood Flow in Humans for First Time

Released on April 8, 2019

Vector flow imaging (VFI) is a technology that utilizes ultrasound to…

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Cardiology

Medtronic touts economic data for HeartWare HVAD

Released on April 8, 2019

Medtronic (NYSE:MDT) today touted more data on the HeartWare left-ventricular assist device it acquired in 2016, saying economic analyses of prior […]

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Cardiology FDA Approved

FDA Approves First New Therapy to Treat Heart Attacks in Years

Released on April 4, 2019

Heart attacks are typically treated by placing stents at the sites of narrowing coronary arteries…

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Cardiology FDA Approved

TherOx wins FDA approval for SuperSaturated Oxygen therapy

Released on April 4, 2019

TherOx said a pivotal trial showed a 26% relative reduction in…

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Cardiology Public Offering

Silk Road Medical upsizes IPO

Released on April 3, 2019

Silk Road Medical today boosted the size of its pending initial public offering to as much as ….

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Cardiology Funding

Endologix inks debt refinancing deal, looks to raise $52m

Released on April 2, 2019

The company said that it also entered into…

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Cardiology FDA Approved

CardioFlux Magnetocardiography System with Faraday Analytical Cloud FDA Cleared

Released on April 2, 2019

Genetesis, a company based in Mason, Ohio, won FDA clearance for its cardiac imaging offering that combines the CardioFlux magnetocardiograph with the the integrated Faraday Analytical Cloud (FAC).

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Cardiology Funding

Fifth Eye nabs $11.5M for clinical early warning systems

Released on April 1, 2019

Fifth Eye, an Ann Arbor, Michigan-based startup, has raised an $11.5 million Series A funding round spearheaded by Arboretum Ventures and Cultivation Capital. MINTS (Michigan Investment in New Technology Startups), the direct investing arm of the University of Michigan’s endowment, also participated.

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Cardiology Funding

BioSig raises $9m

Released on March 29, 2019

BioSig Technologies (OTCQB: BSGM) has raised $8.6 million in a new round of equity financing, according to a recently posed SEC filing.

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Cardiology

CardioFocus is Becoming a Force to Be Reckoned with in AFib Market

Released on March 29, 2019

CardioFocus is quickly positioning itself to be a dominant player in the growing atrial fibrillation (AFib) treatment market.

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Cardiology Digital Health

Aktiia’s Cuffless Blood Pressure Monitor is Accurate for Months

Released on March 29, 2019

The Aktiia PulseWatch optical blood pressure monitor was tested in six healthy volunteers and agreed with a traditional inflating-cuff blood pressure monitor (Omron M6) two months after the initial calibration. The PulseWatch was accurate to within 1 ± 7 mmHg, which satisfied the 5±8 mmHg guidelines set by the AAMI (Association for the Advancement of Medical Instrumentation).

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Cardiology

CytoSorbents receives approval in Israel

Released on March 28, 2019

CytoSorbents (Monmouth Junction, N.J.) recently announced that it has received approval from the State of Israel Ministry of Health’s medical device regulation unit for its CytoSorb blood purification technology.

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Cardiology

HeartLight X3 System for Rapid and Accurate Cardiac Ablation Procedures Cleared in Europe

Released on March 27, 2019

Ablation of cardiac tissue is one of the most common ways of treating atrial fibrillation. Interventional cardiologists have to work quite a bit to make sure the energy they’re delivering hits the correct areas. The HeartLight X3 System from CardioFocus is designed to make this process much faster and it has just been approved in the EU.

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Cardiology

Implant Attached to Heart Generates Electricity to Power Pacemaker

Released on March 26, 2019

Pacemakers, defibrillators and other cardiac implants are life saving devices, but the batteries inside of them remain their Achilles’ heel. Every five to ten years they have to be replaced in another invasive surgery that patients abhor and that put a high cost on the healthcare system.

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Cardiology

Silk Road Medical sets downsized range for IPO

Released on March 26, 2019

Silk Road Medical yesterday set the range on its forthcoming initial public offering, which would fetch $75 million at the midpoint.

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Cardiology FDA Approved Imaging

FDA clears Genetesis’ CardioFlux biomagnetic cardiac imager

Released on March 25, 2019

Genetesis said last Friday it won FDA 510(k) clearance for its CardioFlux biomagnetic cardiac imaging platform.

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Cardiology FDA Approved

Omron wins FDA nod for combined blood pressure monitor, EKG

Released on March 25, 2019

Omron Healthcare (TYO:6645) has won FDA 510(k) clearance for its Blood Pressure Monitor + Echocardiogram device, according to a recently posted FDA release.

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