Ce Marked Medical Device Articles & Analysis
20 news found
As the manufacturer of Asonor®, a CE-marked Class IIa medical device for the treatment of snoring, we offer a well-documented product with: 20+ years of clinical experience Documented effect Approved and registered in more than 70 countries We are now expanding our global distributor network. ...
As the manufacturer of Asonor®, a CE-marked Class IIa medical device for the treatment of snoring, we offer a well-documented product with: 20+ years of clinical experience Documented effect Approved and registered in more than 70 countries We are now expanding our global distributor network. ...
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 European Union (EU) that will allow CardioWise to market its products there. ...
Developing new indications creates opportunity to expand SOZO utilization by placing additional SOZO devices and adding new licenses to existing devices. New indications also support the strategy for building large corporate accounts, many of which have interest in co-development and regulatory clearance for new ways to use SOZO to benefit their cancer patients ...
Frank Vicini, ImpediMed’s Chief Medical Officer. “Many of these patients have survived surgery, chemotherapy, radiation and other treatments, only to face a long-term, painful battle with lymphedema. ...
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 ...
Michael Suk, Professor of Orthopaedic Surgery and Chair of the Musculoskeletal Institute at Geisinger Health System in Danville, PA, Orthopaedic Surgeon, and American Medical Association Board of Trustee. “Tools that can support healthcare providers identifying biomechanical dysfunctions and quantifying the cause of pain and symptoms is a new frontier in diagnosing and ...
ByEmovi
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. ...
Gerardette McGivern, Owner of Happy Feet, had bought a non-medical grade non-contact thermometer to monitor the temperature of patients and staff. ...
SteriLux passes the course of medical certification for the European market, thus demonstrating that its technology meets the most demanding standards in the field of health. Sterilizing heat-sensitive medical instruments without chemicals: this is the objective that the Vaud-based startup SteriLux has set itself since its creation in 2014. ...
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 ...
Epihunter, which last year earned the European CE mark as a class I medical device, is today also launching a new offering towards the B2B market. ...
Healthcare professionals should be regularly trained to handle infective patients and pass through periodic screening for the virus. Dedicated medical air purifying equipment should be used for patient care and environmental infection control. The Chinese authorities combating the outbreak of Coronavirus (COVID-19) have built hospitals in the crisis areas and upgraded their ...
Liberate Medical, a medical device company developing novel non-invasive electrical muscle stimulation devices to help patients with pulmonary conditions, today announced that it has received CE marking for its VentFree™ Respiratory Muscle Stimulator and ISO 13485 certification for its ...
“Boston Children’s Hospital’s clinicians and researchers have extensive experience in setting up and running medical device studies, including those involving seizure monitors. We are eager to measure epihunter’s impact on therapy decision making and daily life,” Rotenberg adds. ...
Belgian startup, epihunter, introduces automated video functionality to their CE-marked seizure detection app - a breakthrough for children and adults with epilepsy, their families and doctors. ...
It is estimated that 1 in 100 people have epilepsy, and 1 in 3 people with epilepsy continue to experience uncontrollable and unpredictable seizures despite medication. Motor seizures, which manifest as repeated automatic movements and unconsciousness, is what most people think of when they hear the word ‘seizure’. ...
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). ...
As a worldwide leading Notified Body, BSI understands the challenges companies face when looking to broaden their employees’ knowledge and understanding of medical device regulations and standards. In fact, over 70% of the top medical device manufacturers worldwide are trained by BSI. ...
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 ...