Aug 10,2022

Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy

Avenda Health announced that it received FDA investigational device exemption (IDE) for its FocalPoint ablation system power by iQuest. iQuest uses artificial intelligence (AI) and deep learning to map prostate cancer and provide physicians with a precise location of cancer within the gland, plus a better understanding of the extent of the disease to help with treatment planning.

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Oct 20,2022 TOP STORY

FDA clears AI-enabled MR tech from Philips

Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its AI-enabled MRCAT head and neck radiotherapy application. Amsterdam-based Philips designed its MRCAT head and neck application to allow for the use of MR as the sole or primary imaging modality for radiotherapy planning. It is used for the treatment of soft tissue tumors in the head and neck, along with the brain, pelvis and prostate.

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May 20,2021

The Vinehealth Cancer Platform receives medical device CE mark certification

Vinehealth has received a Class 1 Medical Device CE mark for its Vinehealth mobile app for cancer patients and VinehealthPRO web application for clinicians. Vinehealth conforms to the requirements of the Medical Devices Directive 93/42/EEC. The Directive outlines safety and performance requirements for medical devices in the UK & EU.

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May 12,2021

Voluntis receives CE Mark for new version of Oleena with expanded clinical intelligence

Voluntis today announced that it has received the CE mark for a new version of Oleena featuring expanded clinical intelligence. Oleena is Voluntis’ proprietary digital therapeutic that supports patients in the self-management of their symptoms in combination with a wide range of cancer treatments, while allowing healthcare teams to remotely monitor the progress of the disease.

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Sep 21,2021

FDA Authorizes Software that Can Help Identify Prostate Cancer

Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue removed from the body). The software, called Paige Prostate, is the first artificial intelligence (AI)-based software designed to identify an area of interest on the prostate biopsy image with the highest likelihood of harboring cancer so it can be reviewed further by the pathologist if the area of concern has not been identified on initial review.

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Mar 04,2020

AI-Pathway Companion Prostate Cancer from Siemens Healthineers Approved for Use in Europe as Medical Device

AI-Pathway Companion Prostate Cancer(2), a digital companion from Siemens Healthineers to support clinical decision-making, has recently received the CE mark for use in the clinical pathway of prostate cancer, the second most common cancer (after lung cancer) affecting males worldwide.(3) The conformity mark confirms that the application AI-Pathway Companion Prostate Cancer is CE-compliant in accordance with Directive 93/42/EEC and can therefore be marketed in the EU as a medical device.

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Nov 16,2020

Voluntis receives CE Mark for Oleena, key milestone to the future commercialization of its digital therapeutic for oncology

Voluntis (Euronext Paris, Ticker: VTX – ISIN: FR0004183960), a leader in digital therapeutics, today announced that it has received the CE mark for Oleena. This is a key first step ahead of the commercialization of its oncology solutions in the European Union.

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Dec 14,2020

AI developer Paige scores CE marks in breast, prostate cancers

Digital pathology developer Paige has received two European approvals for its artificial-intelligence-powered diagnostic platforms in breast and prostate cancers. One CE mark covers breast cancer detection software that automatically highlights suspicious areas on slides of biopsied breast tissue for further review, while a second greenlights software to help rate prostate tumor samples, deliver a prognosis and guide treatment planning.

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Jul 31,2019

Voluntis announces market authorization for Oleena™, first digital therapeutic in oncology

Voluntis (Euronext Paris, Ticker: VTX – ISIN: FR0004183960), a leader in digital therapeutics, today announced it has successfully completed a U.S. Food and Drug Administration (FDA) regulatory review of its Oleena™ software for oncology-related symptoms management and remote patient monitoring. Oleena™ is determined as Class II medical device falling under enforcement discretion per FDA Guidance.

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Oct 20,2014

Philips Digital Pathology Solution Receives CE Mark for Diagnosis to Help Advance Oncology Diagnosis

Royal Philips (NYSE: PHG, AEX: PHIA) has acquired the CE mark for diagnostic use of its Philips Digital Pathology Solution. European pathologists will now be able to use the full digital solution as an aid in diagnosis for routine pathology, such as primary diagnosis of oncology.

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