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In Vitro Medical Articles & Analysis

9 news found

Robocath’s joint venture, Cathbot, concludes first clinical study in China to evaluate robotic PCI safety and efficacy

Robocath’s joint venture, Cathbot, concludes first clinical study in China to evaluate robotic PCI safety and efficacy

I am very impressed with the commitment of the Cathbot team and the medical staff. They worked very hard to make it happen on time and to maintain our strategic plans despite the lockdowns. ...

ByRobocath


Robocath successfully completes first robotic coronary angioplasty with R-One in China

Robocath successfully completes first robotic coronary angioplasty with R-One in China

Following years of research and development, innovation and industrial accumulation, MedBot has grown to become a medical robotics company that masters the underlying technology in the entire chain. MedBot’s three flagship products in the three major segments, namely the Toumai™ laparoscopic surgical robot, Skywalker™ joint replacement surgical robot and ...

ByRobocath


Cairn Diagnostics Delivers Virtual Administration of its Novel 13C-Spirulina Gastric Emptying Breath Test

Cairn Diagnostics Delivers Virtual Administration of its Novel 13C-Spirulina Gastric Emptying Breath Test

GEBT is an FDA-PMA approved, CE marked, Class III in-vitro diagnostic drug-medical device combination[i]product used for measuring the rate of solid phase gastric emptying and identifying delayed gastric emptying, a condition known as gastroparesis, in patients ages 18 years and older. ...

ByCairn Diagnostics


Sonic Incytes Selected for MedTech Innovator Asia Pacific Accelerator

Sonic Incytes Selected for MedTech Innovator Asia Pacific Accelerator

UpperMed – Singapore VPIX Medical – Daejeon, South Korea ZuoYuan Medical – Hangzhou, China MedTech Innovator’s 2021 Asia Pacific program sponsors include Johnson & Johnson Medical Devices Companies, Align Technology, Nipro Medical Corporation, Oliver Healthcare Packaging, Olympus ...

BySonic Incytes Medical Corp.


Peer-Reviewed Journal Publishes PrecivityAD™ Blood Test Research, Confirming Its Role in Assisting Clinicians in Alzheimer’s Diagnosis

Peer-Reviewed Journal Publishes PrecivityAD™ Blood Test Research, Confirming Its Role in Assisting Clinicians in Alzheimer’s Diagnosis

” The research paper in Molecular Neurodegeneration adds that the test’s “excellent performance” for Alzheimer’s disease (AD) diagnosis allows for “improved medical decision making and management, streamlined AD clinical trial enrollment, and better identification of who may benefit from an AD specific ...

ByC2N Diagnostics


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, on the basis of demonstration, ...

ByMiconvey Technologies Co., Ltd


Waters ACQUITY UPLC I-Class/Xevo TQ-S micro System available as a U.S. FDA Class I, CE-Marked Medical Device

Waters ACQUITY UPLC I-Class/Xevo TQ-S micro System available as a U.S. FDA Class I, CE-Marked Medical Device

Waters Corporation (NYSE: WAT) today announced that the Waters® ACQUITY UPLC® I-Class IVD/Xevo® TQ-S micro IVD System is now manufactured as a U.S. FDA Class I medical device and is CE Marked to the European Directive 98/79/EC (IVDD). ...

ByWaters Corporation


BSI extends healthcare rReach with Eurocat acquisition

BSI extends healthcare rReach with Eurocat acquisition

EUROCAT also has a growing customer base in Russia and Turkey.EUROCAT is accredited by all relevant bodies for the certification of medical devices, in-vitro diagnostics and active implantable devices, and is renowned for ensuring a high level of customer confidence in its services. Product testing and CE certification by EUROCAT allows the movement of ...

ByBSI Consulting


BSI expediting expansion of in vitro diagnostic scope for medical devices

BSI expediting expansion of in vitro diagnostic scope for medical devices

BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, is rapidly implementing plans to expand its medical device Notified Body scope to include in vitro diagnostic (IVD) devices. ...

ByBSI Consulting

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