medical device CE marking News
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BSI group America Inc. Announces specialized regulatory training courses for the healthcare industry
BSI Group America Inc., a leading provider of total solutions for certification and standards announces the launch of Specialized Regulatory Training courses targeted specifically for the medical device industry. Available on-site, these Specialized Regulatory Courses reflect requirements of the latest amendments to the Medical Device Directive enabling attendees to comply efficiently with ...
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BSI launches new CE-Dedicated FastTrack Program at RAPS Conference
BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, today announced the launch of CE-Dedicated FastTrack. This new CE marking program is designed to help medical device manufacturers get their products quickly and safely to European markets. BSI will debut the program at the 2009 Regulatory Affairs Professionals ...
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AcuPebble SA100 joins the NHS Innovation Accelerator 2021
AcuPebble SA100, the first medical device to obtain the CE mark for the automated diagnosis of Obstructive Sleep Apnoea, has been announced as one of 12 exciting innovations to join the NHS Innovation Accelerator 2021. This award-winning programme identifies early-stage solutions which address the most pressing needs of the NHS, and supports them over three years as they scale across England for ...
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Infection transmission prevention and control of Coronavirus (COVID-19) made possible through Genano Air Decontamination Units
Infection control procedures including work practices, protocols and controls, environmental hygiene, air filtration and appropriate use of Personal Protective Equipment (PPE) are all necessary to prevent infections from spreading during healthcare service delivery. But in the case of the recent Coronavirus (COVID-19) outbreak early detection and isolation of potentially infectious patients is ...
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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). This development allows clinical laboratories to access leading innovations in liquid chromatography (LC) and mass spectrometry (MS) technology for the ...
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TRITEMP Helps Local Business Remain Open During the Pandemic
Happy Feet Podiatry Services decided to use the TRITEMP Non-contact thermometer after being dissatisfied with a lesser quality non-contact thermometer that they had previously purchased. Gerardette McGivern, Owner of Happy Feet, had bought a non-medical grade non-contact thermometer to monitor the temperature of patients and staff. This was as an extra measure to help protect against COVID-19, ...
By TriMedika
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Acurable receives US FDA clearance for its home sleep apnoea testing device AcuPebble SA100
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, which received a CE Mark as a Class IIa medical device in 2020, was developed and is commercialised by UK-based medical device company Acurable and builds on more than ten ...
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Acurable launches groundbreaking technology to diagnose sleep apnoea remotely
Acurable, a fast-growing medical device company, has announced the availability of its first product, AcuPebble SA100, a small wearable device which for the first time enables a fully automated and remote diagnosis of obstructive sleep apnoea (OSA). Traditionally, the diagnosis of OSA has required multiple hospital visits for patients, and doctors have had to manually review and analyse data from ...
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CardioWise™ Receives ISO 13485:2016 Clearance for Design, Development, and Marketing of Software as a Medical Device (SaMD) For the Medical Device Industry
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE mark and Medical Device Registration for the ...
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Silver Bullet Therapeutics Announces Issuance of U.S. Patent No. 8,999,367 for Bioabsorbable Substrates That Controllably Release Metal Ions
Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that the U.S. Patent and Trademark Office issued Patent No. 8,999,367 as a continuation of patent No. 8,927,004 that significantly enhances the claims for the release of antimicrobial metal ions to prevent infection. Paul Chirico, President and CEO of Silver Bullet Therapeutics stated, “We take a lot ...
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EDGe Surgical Receives CE Mark Certification for EDG Ortho 65mm Electronic Depth Gauge
EDGe Surgical, Inc., a company focused on developing and manufacturing smart orthopedic and spine surgical instruments, announced today that it has received a CE Certificate of Conformity from its notified body permitting CE mark of the company’s EDG Ortho 65mm single-use electronic depth gauge in the European Union market. “This is a great achievement for EDGe Surgical on several ...
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Oncomfort and Vygon sign international partnership for commercialization of Sedakit™, the Digital Sedation™ Virtual Reality solution
Oncomfort, the Belgian inventor of Digital SedationTM - a new method for relieving patients’ pain and anxiety without medication –, and Vygon, global group specializing in single-use medical devices, today announce their commercial partnership in six European countries. The strong synergy between Vygon's specialization and Oncomfort's fields of application will enable greater ...
By Oncomfort
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New Bone Data Comparing ImpediMed’s SOZO to DXA in Cancer Patients to be Presented at 39th Annual Miami Breast Cancer Conference
ImpediMed Limited (ASX.IPD), a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximize patient health is pleased to announce an abstract comparing concurrent measures using ImpediMed’s SOZO® Digital Health Platform and dual x-ray absorptiometry (DXA) for assessing in bone mineral content in cancer patients was accepted for ...
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The American Academy of Orthopedic Surgeons has just recognized that when integrated in patient education, Knee Kinesiography with the KneeKG system provides statistically significant and clinically superior improvements compared to the results obtained w
Emovi inc. is pleased to announce that Geisinger Health, comprised of nine hospital campuses, two research centers, a college of medicine, and a 550,000-member health plan serving more than three million residents in central, south-central, and northeast Pennsylvania, broadens its care and support for patients experiencing knee pain with the addition of five KneeKG Systems into their clinics. ...
By Emovi
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Laser hair removal? Rely on the AlexPRO handpiece by Biotec Italia Medical
AlexPro by Biotec Italia is a medical device for laser hair removal that is effective on all skin types and meets all the production requirements of the new European regulation MDR745. A necessary premise Since epilation using lasers can be carried out with both a medical device and a device for aesthetic use, very often, the devices on the market suitable for this purpose that use light energy ...
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New Data Show Statistically Significant Reduction in Chronic Cancer-Related Lymphedema with Early Detection Using ImpediMed’s L-Dex® Technology and Intervention
Lymphatic Research and Biology Publishes Data on PREVENT, the Largest Randomized Trial to Assess Lymphedema Prevention L-Dex Technology Provides a New Standard Approach for Prevention of Cancer-Related Lymphedema ImpediMed Limited (ASX: IPD), a global medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to maximize patient health, today ...
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