Medical Device Regulations Articles & Analysis

American Conference Institute is proud to announce that we are bringing our 5th Annual FDA Boot Camp- Devices Edition, back to Chicago on July 26-28, 2017. We specifically tailor this conference to provide regulatory professionals with in-depth coverage of current FDA law and regulations. New for this year, we have a fresh Ripped from the Headlines session, covering key developments in the FDA ...

By American Conference Institute - C5 Group

U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that the product has the same safety and effectiveness in terms of intended use, design, ...

By Proregulations

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 ...

By EDGe Surgical, Inc.

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 ...

By BSI Consulting

Little Rock, AR – NuShores Biosciences LLC (NuShores), founded and based in Little Rock, Arkansas, announced today that Mr. Sam Monk has accepted the position of Regulatory and Quality Manager and will move to Little Rock from the Seattle area. Mr. Monk will work closely with C-level management, research scientists, manufacturing, and our Quality and Regulatory team and services providers ...

By NuShores Biosciences LLC

While medical AI has many potential benefits, there are challenges that have not been tackled yet. One of the major challenges is the limited generalizability of many AI algorithms. Applying a medical AI algorithm that is trained in hospital A may give unexpected results when applied in hospital B. Why does this happen? Certain parameters are different between hospitals. If hospital A has Siemens ...

By Segmed, Inc.

The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA. The agenda lists the following presentations: A Decade of Progress and Innovation in Nanotechnology at U.S. FDA; Considering Whether an FDA-Regulated Product ...

By Bergeson & Campbell, P.C.

Rejoint provides the holistic approach for total knee replacement called YourKnee™ which has received the Conformité Européene (CE) Mark in January 2020. The CE marking confirms that YourKnee meets the requirements of the European Medical Devices Directive, which allows Rejoint to commercialize YourKnee and all its disposable products across the European Union and other CE ...

By Rejoint SRL

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. Its product, of sustainable design, uses ...

By SteriLux SA

Revolutionary bleeding control technology will now be available in Europe and other International markets. RevMedx, Inc., a leader in innovative devices that control severe bleeding, today announced it has received CE (Conformité Européenne) Mark Certification for the XSTAT 30 and XSTAT 12 hemostatic devices in Europe. Unlike traditional wound treatments that may take several ...

By RevMedx

Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Lynn L. Bergeson will speak, Saturday, December 4, 2010, about Toxic Substances Control Act (TSCA) reform legislation and the role of the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program at the Seventh ...

By Acta Group

Manufacturer of the revolutionary XSTAT technology will now have a second sterile wound dressing available in Europe and other International markets. RevMedx, Inc., a global leader in innovative devices that control severe bleeding, today announced it has received CE (Conformité Européenne) Mark Certification for the XGAUZE wound dressing in Europe. XGAUZE, a Class I sterile ...

By RevMedx

V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union. “More than 26 million people suffer from chronic heart failure worldwide, and HF remains a leading driver of ...

By V-Wave Ltd.

CORK MEDTECH STARTUP AventaMed has joined a consortium of big-name healthcare companies for collaborations ahead of a planned US launch. AventaMed has developed a device for inserting grommets into the eardrum, which prevents the build up of fluid. The consortium – called the National Evaluation System for Health Technology Coordinating Center (NESTcc) – connects regulators and the ...

By AventaMed DAC

BioQ Pharma Incorporated (“the Company”), a specialty pharmaceutical company, today announced receipt of CE mark approval in the European Union for its OneDose ReadyfusOR Gen2, single-use medication dispenser. The OneDose ReadyfusOR Gen2 is the second generation of the Company’s original OneDose ReadyfusOR infusion system and was developed to further improve patient convenience. ...

By BioQ Pharma

V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union. “More than 26 million people suffer from chronic heart failure worldwide, and HF remains ...

By V-Wave Ltd.

For VisionQuest’s vice president and principal investigator Vinayak Joshi (PhD), the journey from idea to commercial product has led him halfway around the world. Dr. Joshi recently traveled to Malawi, Kenya, Nigeria, and Ghana as part of his efforts to commercialize ASPIRE, his device for the detection and diagnosis of malarial retinopathy. While in Africa, he met with leaders in ...

By VisionQuest Biomedical Inc.

AventaMed, a Cork-based medical device start-up which is set to revolutionise paediatric ear, nose and throat surgery has beaten 26 global organizations in a major medical device bid. The pioneering company will be one of 12 Real-World Evidence Test-Cases selected by The National Evaluation System for Health Technology Coordinating Center (NESTcc) to evaluate the use of real-world evidence (RWE) ...

By AventaMed DAC

BloodCenter of Wisconsin (BCW, part of Versiti) and Eastman Chemical Company (NYSE:EMN) have announced the results of a recent clinical trial evaluating a new plasticizer for blood bags. While di-2-ethylhexyl phthalate (DEHP) has provided the medical industry with a stable ortho-phthalate plasticizer for many years, regulatory trends and consumer demands will inevitably drive the industry to ...

By Eastman Chemical Company

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced its operating and financial results for the fourth quarter and full-year 2020. Recent Highlights Senhance Surgical System received expanded 510(k) clearance for general ...

By Asensus Surgical US, Inc.