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Therapeutic Device Articles & Analysis

18 news found

BioIntelliSense Launches Patented, FDA-cleared Pulse Oximetry (SpO2) Sensor Technology that Addresses Skin Pigmentation and Motion Monitoring Challenges

BioIntelliSense Launches Patented, FDA-cleared Pulse Oximetry (SpO2) Sensor Technology that Addresses Skin Pigmentation and Motion Monitoring Challenges

Breakthrough pulse oximetry (SpO2 ) optical sensor solution offers medical-grade accuracy of oxygen level measurement across skin tones and while in motion Patented SpO2 sensor chipset, integrated processing and reference design capability to power the next generation of medical and consumer wearable devices BioIntelliSense, a continuous health monitoring and clinical intelligence company, ...

ByBioIntelliSense, Inc.


Enrollment Completed In Reflow Medical’s DEEPER OUS Clinical Trial

Enrollment Completed In Reflow Medical’s DEEPER OUS Clinical Trial

Reflow Medical, Inc. announces that it has completed patient enrollment in the DEEPER OUS clinical trial (NCT03807531) for the company’s Temporary Spur Stent System, a novel device that features a retrievable stent designed for complex infrapopliteal disease. 106 patients have now been enrolled in the prospective, nonrandomized trial in multiple centers in Europe and New ...

ByReflow Medical, Inc.


NanoVibronix Extends Reach of UroShield and PainShield through MTSG`s International Network

NanoVibronix Extends Reach of UroShield and PainShield through MTSG`s International Network

NanoVibronix, Inc., (NASDAQ: NAOV) , a medical device company that produces the UroShield® and PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced it has signed an International Marketing, Sales and Clinical Management Agreement with Medtech Solutions Group (“MTSG”), a leader in the ...

ByNanoVibronix


NanoVibronix to Present at the H.C. Wainwright BioConnect Virtual Conference

NanoVibronix to Present at the H.C. Wainwright BioConnect Virtual Conference

NanoVibronix Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield® and PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced it will be featured as a presenting company at the H.C. ...

ByNanoVibronix


Reflow Medical Receives Approval In Japan For The Wingman Catheter To Cross Chronic Total Occlusions (CTOs) In Peripheral Artery Disease

Reflow Medical Receives Approval In Japan For The Wingman Catheter To Cross Chronic Total Occlusions (CTOs) In Peripheral Artery Disease

Reflow Medical, Inc., a California- based medical device company, announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman™ CTO Catheter. Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading medical device distributor based in Tokyo, to introduce the Wingman CTO Catheter in ...

ByReflow Medical, Inc.


Canadian Ambassador to China Dominic Barton visited SWS Medical

Canadian Ambassador to China Dominic Barton visited SWS Medical

On May 31, 2021, Mr. Dominic Barton, Canadian Ambassador to China, accompanied by Consul General Jeff David and trade commissioners from the Canadian Consulate General in Chongqing, visited SWS ...

BySWS Hemodialysis Care Co., Ltd.


Fibralign Selected as a UCSF Rosenman Institute Innovator

Fibralign Selected as a UCSF Rosenman Institute Innovator

The 2021 Rosenman Innovator cohort: Auricle, Inc. is a medical device venture focused on commercializing the first validated and effective therapy that treats tinnitus at its source. ...

ByFibralign Corporation


The UCSF Rosenman Institute Announces the 2021 Rosenman Innovators

The UCSF Rosenman Institute Announces the 2021 Rosenman Innovators

The 2021 Rosenman Innovator cohort: Auricle, Inc. is a medical device venture focused on commercializing the first validated and effective therapy that treats tinnitus at its source. ...

ByInvenio Imaging Inc.


BrainQ gets FDA Breakthrough status for its device for reducing disability following stroke

BrainQ gets FDA Breakthrough status for its device for reducing disability following stroke

JERUSALEM, Feb. 11, 2021-- BrainQ, the Israeli start-up with a therapeutic solution to reduce disability following stroke, announced today that the United States Food and Drug Administration (FDA) has designated its AI-powered technology as a Breakthrough Device. ...

ByBrainQ Technologies


FDA Approves Theranica`s Nerivio® for Acute Treatment of Migraine in Adolescents

FDA Approves Theranica`s Nerivio® for Acute Treatment of Migraine in Adolescents

Theranica, a prescribed digital therapeutics (PDT) company developing advanced electroceuticals for migraine and other pain conditions, today announced that its Nerivio® therapeutic device has received the Food and Drug Administration clearance to market for an expanded indication for acute treatment of episodic or chronic migraine in people ...

ByTheranica Bio-Electronics Ltd.


Cerus Endovascular Receives CE Mark Approval for its Contour 021 device

Cerus Endovascular Receives CE Mark Approval for its Contour 021 device

Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced that it has received CE Mark approval for its state of the art CerusEndo MC 021 microcatheter, designed to allow physicians to access tortuous neurovasculature and deliver therapeutic devices to intended targets. ...

ByCerus Endovascular Inc.


Aatru Medical, LLC submits NPSIMS product to FDA for Class II Clearance and completes Series C funding

Aatru Medical, LLC submits NPSIMS product to FDA for Class II Clearance and completes Series C funding

Aatru Medical, LLC ("Aatru") is pleased to announce its recent submission to the FDA of a traditional 510(k) premarket notification application for the company's first product, NPSIMS - Negative Pressure Surgical Incision Management System. The submission efforts were led by Aatru President and Board Member Edward Armstrong, in conjunction with Coastal Consulting Group, NAMSA, and DuVal & ...

ByAatru Medical, LLC


Reflow Medical Announces 510(K) Clearance For An Expanded Indication For The Wingman Catheter To Cross Chronic Total Occlusions (CTOs) In Peripheral Artery Disease

Reflow Medical Announces 510(K) Clearance For An Expanded Indication For The Wingman Catheter To Cross Chronic Total Occlusions (CTOs) In Peripheral Artery Disease

Reflow Medical, Inc., a California-based medical device company, has announced that they have received clearance from the FDA for an expanded indication for the Wingman™ Crossing Catheter after completing the Wing-IT clinical trial. The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip that creates a channel to help penetrate, or cross, the occlusion ...

ByReflow Medical, Inc.


Orchestra BioMed Strengthens Management Team with Appointments of Expert Product Development Leaders Juan A. Lorenzo and Paul V. Goode, Ph.D.

Orchestra BioMed Strengthens Management Team with Appointments of Expert Product Development Leaders Juan A. Lorenzo and Paul V. Goode, Ph.D.

I recognize how this novel technology transforms the most well-established bioelectronic device platform there is, pacemakers, into a potent treatment for one of the most challenging and pervasive medical conditions worldwide. ...

ByOrchestra BioMed, Inc.


V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure

V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure

V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. ...

ByV-Wave Ltd.


NeoTherma Oncology Receives NCI Grant to Advance VectRx MRI Thermometry

NeoTherma Oncology Receives NCI Grant to Advance VectRx MRI Thermometry

NeoTherma Oncology (NTO), developer of an advanced bioelectric medical device for noninvasive treatment of serious cancers, today announced the Company was recently awarded Small Business Innovation Research grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). ...

ByNeoTherma Oncology


NeoTherma Oncology Raises $6 Million to Advance VectRx to Human Testing

NeoTherma Oncology Raises $6 Million to Advance VectRx to Human Testing

NeoTherma Oncology (NTO), developer of an advanced bioelectric medical device for noninvasive treatment of serious cancers, today announced the closing of a $6 million capital raise. ...

ByNeoTherma Oncology


Olympus Extends Portfolio of EndoTherapy Solutions at DDW

Olympus Extends Portfolio of EndoTherapy Solutions at DDW

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today the availability of several new endoscopic therapeutic devices, to be unveiled at the upcoming Digestive Disease Week conference May 6-9 in Chicago, Ill. ...

ByHSM GmbH Co. KG

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