510k Submission Planning

510k Submission Planning

By Joy Greidanus

…landscape and focus on competitor devices. View content such as research literature, clinical studies, websites, brochures, sell-sheets, instructions for use, and labeling to identify potential predicate device(s) with the same…

…landscape and focus on competitor devices. View content such as research literature, clinical studies, websites, brochures, sell-sheets, instructions for use, and labeling to identify potential predicate device(s) with the same…

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FDA Logo

FDA Announces Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge Winners

By MedTech Intelligence Staff

…judged by a combination of clinical and data science subject matter experts, and were evaluated on several aspects, including: Innovation in clinical predictors Completeness of data science approach Statistical metrics…

…judged by a combination of clinical and data science subject matter experts, and were evaluated on several aspects, including: Innovation in clinical predictors Completeness of data science approach Statistical metrics…

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Medtronic Percept RC

FDA Approves Medtronic Percept RC Neurostimulator for Deep Brain Stimulation

By MedTech Intelligence Staff

…“This new rechargeable neurostimulator technology provides me with insights into my patients’ symptoms and can capture data even when they’re outside of the clinic,” said Eleni Okeanis Vaou, M.D., FAAN,…

…“This new rechargeable neurostimulator technology provides me with insights into my patients’ symptoms and can capture data even when they’re outside of the clinic,” said Eleni Okeanis Vaou, M.D., FAAN,…

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Sudhir Kesavan

CitiusTech Appoints Sudhir Kesavan as Chief Operating Officer

By MedTech Intelligence Staff

Sudhir Kesavan is the new Chief Operating Officer (COO) of CitiusTech, a provider of healthcare technology services, solutions and platforms. In his new role, he will assume responsibility for leading…

Sudhir Kesavan is the new Chief Operating Officer (COO) of CitiusTech, a provider of healthcare technology services, solutions and platforms. In his new role, he will assume responsibility for leading…

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UK Flag

MHRA Releases Roadmap of Future UK Medical Device Regulation

By MedTech Intelligence Staff

new regulations via a series of new Statutory Instruments (SIs). The agency will put priority measures to protect patient safety into place this year, with core elements of the new

new regulations via a series of new Statutory Instruments (SIs). The agency will put priority measures to protect patient safety into place this year, with core elements of the new

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The LUNA Surgical System

Flex To Provide Advanced Manufacturing Services for Asensus Surgical’s LUNA Robotic Surgical System

By MedTech Intelligence Staff

“Flex’s proven track record of delivering complex electromechanical systems across diverse industries and deep understanding of the complex requirements for medical devices will enable us to accelerate time-to-market for our…

“Flex’s proven track record of delivering complex electromechanical systems across diverse industries and deep understanding of the complex requirements for medical devices will enable us to accelerate time-to-market for our…

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Microphone

Call for Abstracts: MTI Regulatory Intelligence and Networking Summit

By MedTech Intelligence Staff

…June 3-5, 2024, Washington, DC, offers education and discussion for the Medtech community as it works to develop processes, procedures and solutions to streamline global and product lifecycle regulatory compliance….

…June 3-5, 2024, Washington, DC, offers education and discussion for the Medtech community as it works to develop processes, procedures and solutions to streamline global and product lifecycle regulatory compliance….

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NIST logo

NIST Seeks Input on Development and Use of AI

By MedTech Intelligence Staff

…will be accepted until Feb. 2, 2024, and will be posted to www.regulations.gov. The information collected will inform the drafting of guidance that NIST will release for public comment.  …

…will be accepted until Feb. 2, 2024, and will be posted to www.regulations.gov. The information collected will inform the drafting of guidance that NIST will release for public comment.  …

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Northwestern IV Bag recycling program

Baxter Advances IV Bag Recycling Pilot for U.S. Hospitals

By MedTech Intelligence Staff

Baxter International announced that it has completed the first phase of its intravenous (IV) bag recycling program pilot and is now expanding the pilot program. Launched in conjunction with Northwestern…

Baxter International announced that it has completed the first phase of its intravenous (IV) bag recycling program pilot and is now expanding the pilot program. Launched in conjunction with Northwestern…

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