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Medical Device Management Articles & Analysis

21 news found

InnovHeart raises $55 million in Series C financing to further develop the Trans-septal Saturn Transcatheter Mitral Valve Replacement System

InnovHeart raises $55 million in Series C financing to further develop the Trans-septal Saturn Transcatheter Mitral Valve Replacement System

Commenting on this new collaboration, Shawn Chen, Senior management of the Medical Device Division of Grand Pharma, said, ’We are very excited about this collaboration. The successful closing of this transaction demonstrates that Grand Pharma has completed the strategic layout in our cerebro-cardiovascular high-end medical ...

ByInnovHeart Srl.


Hyalex Receives ISO 13485 Certification

Hyalex Receives ISO 13485 Certification

We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a regulatory requirement and international standard outlining requirements for a medical device quality management system. ...

ByHyalex Orthopaedics, Inc.


Michael Herring Joins HD Medical as US Vice President of Sales

Michael Herring Joins HD Medical as US Vice President of Sales

Herring brings his 25 years of experience in medical device sales to the company, having previously worked for 3M, Cantel Medical, Nanosonics, and TSO3. Herring plans to leverage his unique background in medical device sales management and training to further elevate the company as it continues ...

ByHD Medical, Inc.


Quasar Medical Announces Alex Wallstein as Chief Executive Officer

Quasar Medical Announces Alex Wallstein as Chief Executive Officer

Quasar Medical, a leading global contract manufacturer of high precision, minimally invasive medical devices, announces today that its board of directors has named Alex Wallstein as Chief Executive Officer. ...

ByQuasar Medical Ltd.


BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure

BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure

BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter Ventricular Restoration (TCVR), today announced that heart failure specialist Jerry Estep, MD, of the Cleveland Clinic has been appointed co-principal investigator of the pivotal ALIVE Trial studying LIVE Therapy using the Revivent TC ...

ByBioVentrix, Inc.


BlueWind Medical Strengthens Board of Directors with appointment of Kerry Nelson

BlueWind Medical Strengthens Board of Directors with appointment of Kerry Nelson

BlueWind Medical, a medical device company developing minimally invasive neurostimulation devices, announced today the appointment of Kerry Nelson to the company’s Board of Directors. Nelson is a successful medical device investor and fund manager who has launched and ...

ByBlueWind Medical


V-Wave Announces appointment of Bill Hughes as Chief Financial Officer

V-Wave Announces appointment of Bill Hughes as Chief Financial Officer

Hughes brings more than 20 years of financial and operational experience in senior executive leadership positions in the medical device industry, successfully managing privately and publicly held enterprises and offering expertise in scaling companies globally, managing operations and finance, and successfully completing ...

ByV-Wave Ltd.


Exsomed Corporation Announces Completion of MDSAP Certification and ISO 13485:2016 Audit With Zero Findings

Exsomed Corporation Announces Completion of MDSAP Certification and ISO 13485:2016 Audit With Zero Findings

ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, announced that it has successfully completed Medical Device Single Audit Program (MDSAP) certification and ISO 13485:2016 audits, with no open findings. MDSAP is a program that allows ...

ByExsoMed Corporation


Silk Road Medical Names Rick Anderson to Board of Directors

Silk Road Medical Names Rick Anderson to Board of Directors

Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that medical device industry veteran Rick Anderson has joined its board of directors. Anderson brings over 30 years of senior executive leadership experience in the medical device ...

BySilk Road Medical, Inc.


CoapTech Raises $7M in Series B Funding Led by Hunniwell

CoapTech Raises $7M in Series B Funding Led by Hunniwell

CoapTech, a leading medical device start-up pioneering the world’s first and only ultrasound-based feeding tube placement system, announced the closing of a Series B investment of $7 million led by medical device venture capital firm Hunniwell Lake Ventures. ...

ByCoapTech


BlueWind Initiates U.S. Enrollment in Clinical Trial of the RENOVA iStim to Treat Overactive Bladder

BlueWind Initiates U.S. Enrollment in Clinical Trial of the RENOVA iStim to Treat Overactive Bladder

BlueWind Medical announced today that enrollment has commenced at U. S. sites in the Pivotal Clinical Trial of the RENOVA iStim™ implantable tibial neuromodulation System (RENOVA) for the treatment of Overactive Bladder (OAB) following conditional Investigative Device Exemption (IDE) approval by the U.S. ...

ByBlueWind Medical


Avelas Welcomes Susan Stimson to its Board of Directors

Avelas Welcomes Susan Stimson to its Board of Directors

With over 20 years’ experience in healthcare, Susan is recognized as a respected leader in development and commercialization of new medical technologies. She currently serves as Executive in Residence on KCK Group’s Medical Technology team, where she applies her expertise to their portfolio of commercial stage medtech companies and evaluates new ...

ByAvelas Biosciences


Biomatlante receives MDSAP Accreditation

Biomatlante receives MDSAP Accreditation

Biomatlante, a world leader in synthetic bone regeneration technologies, is pleased to announce the obtention of the MDSAP* accreditation on the new ISO 13485:2016 Certificate. The Medical Device Single Audit Program (MDSAP) is an international program for assessing the quality management systems of medical ...

ByBiomatlante SAS


SteriLux has received ISO 13485:2016 certification

SteriLux has received ISO 13485:2016 certification

We are excited to announce that SteriLux has received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the ...

BySteriLux SA


Inceptus Announces Completion of Series B Financing for Okami Medical

Inceptus Announces Completion of Series B Financing for Okami Medical

Inceptus Medical LLC, a medical device company incubator, announced today that it has completed a $4.5M Series B financing for Okami Medical Inc. ...

ByOkami Medical


Two ministries support the domestic medical equipment and will establish incentive mechanism

Two ministries support the domestic medical equipment and will establish incentive mechanism

Recently, the National Health Commission and the Ministry of Industry jointly held the conference to promote the development and application of domestic medical equipment, the domestic medical equipment upgrades once again become the focus. Miao Wei, Minister of Industry and Information, said that in order to promote the development of domestic ...

ByMiconvey Technologies Co., Ltd


The state drug administration issued five medical devices regulations

The state drug administration issued five medical devices regulations

Recently the state food and drug supervision and administration bureau released five related medical devices regulations come into force as of June this year to the new revision of the regulations on the supervision and administration of medical devices, authorized by the state administration of the in-depth research, many times, ...

ByMiconvey Technologies Co., Ltd


Renishaw opens dedicated healthcare facility at its South Wales site

Renishaw opens dedicated healthcare facility at its South Wales site

The Centre, which was formally opened on 29th September by The Rt Hon Carwyn Jones AM, First Minister of Wales, provides a facility for the manufacture of custom medical devices, as well as education and training for the life sciences community. ...

ByRenishaw plc


dBMEDx™ , Inc. Announces CE Mark for BBS Revolution™ Bladder Scanner

dBMEDx™ , Inc. Announces CE Mark for BBS Revolution™ Bladder Scanner

dBMEDx, Inc., a privately-held, wireless medical device company, announced today that it has received the CE Mark for the BBS Revolution™, a next generation bladder scanner which offers, for the first time, fully automated bladder detection and unparalleled ease of use, speed and accuracy for the non-invasive measurement of bladder volume. ...

BydBMEDx


BioLargo Adds Wound Management Expert and Former VP at Smith & Nephew, Tanya Rhodes, to Its Team

BioLargo Adds Wound Management Expert and Former VP at Smith & Nephew, Tanya Rhodes, to Its Team

(OTCBB: BLGO) announced today that former Smith & Nephew Vice President of Innovation (and Vice President at Smith & Nephew Wound Management) Tanya Rhodes has joined the BioLargo management team as a senior strategy advisor. Rhodes will work closely with BioLargo and its recently formed medical subsidiary to commercialize its technology ...

ByBiolargo, Inc.

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