Jun 01,2023

Startup Ezra wins FDA clearance for AI that enhances MRIs

Ezra today announced it received FDA 510(k) clearance for its Ezra Flash AI platform that enhances the quality of MR images. Ezra’s technology leverages AI across all three key components of the cancer screening process, which includes imaging, analysis and reporting. Ezra Flash AI enables Ezra to increase MR image quality, Ezra Prostate AI assists radiologists in the analysis of MR images of the prostate and Ezra Reporter AI creates an easily digestible translation of radiology reports that assist medical professionals in communicating screening results to people. Ezra Flash has so far received FDA clearance for use in the brain. The company said that its full Boyd MRI, which previously took one hour, is now available as a 30-minute MRI scan. Ezra’s ultimate goal is to reduce the time to 15 minutes.

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May 01,2023

Tempus Receives U.S. FDA Approval for xT CDx, a NGS-Based In Vitro Diagnostic Device

Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first Premarket Approval (PMA) application for its companion diagnostic test, xT CDx. xT CDx is a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients. The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms.

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Mar 23,2023

Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

Huma Therapeutics today announced that it has become the only company in the world to receive EU MDR 2017/745 Class IIb certification for a disease agnostic Software as a Medical Device (SaMD). Achieving Class IIb certification means that the SaMD platform is permitted to monitor patients of all ages with any condition - including infants and in pregnancy - and can connect with a range of external devices, such as heart rate, blood sugar monitors or smart inhalers. In addition to enabling disease self-management by patients, it can also support clinicians to manage serious and critical conditions such as heart failure, COPD exacerbations, surgical recovery, cancer, immunodeficiency, asthma attacks and more.

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Mar 20,2023

Lunit Meets MDR CE Requirements for 3D Breast Tomosynthesis AI Solution

Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer solutions, today announced that its AI solution for 3D Breast Tomosynthesis (DBT) analysis, Lunit INSIGHT DBT, has met the requirements of the CE marking under Europe's latest Medical Device Regulation (MDR). From May 2024, products without MDR CE certification will be banned from sale in the EU, making it vital for companies to obtain this certification to enter the market. Lunit developed Lunit INSIGHT DBT based on the evaluation that Lunit INSIGHT MMG is one of the most precise AI for commercialized breast screening. Lunit INSIGHT DBT analyzes 3D images from DBT to enable fast and accurate diagnosis of breast cancer.

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Mar 08,2023

Coreline Soft bags FDA 510(k) for AI lung cancer detection software

South Korean medtech firm Coreline Soft has obtained the United States Food and Drug Administration's 510(k) clearance for its latest AI-powered analysis software for screening lung nodules. The company develops AI imaging solutions for diagnosing various chest conditions, aortic disease, spinal disease, and metastatic cancer in the chest. Its latest software-as-a-medical device called AVIEW Lung Nodule CAD uses AI to detect lung nodules, which are a major indication of the so-called "big three" diseases: lung cancer, chronic obstructive pulmonary disease, and cardiovascular disease.

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Dec 15,2022

FDA says yes to MedCognetics breast cancer screening AI

Digital health company MedCognetics has picked up an FDA approval for QmTRIAGE, its artificial intelligence-powered software for detecting breast cancer in medical images. The company said QmTRIAGE can help alleviate a chronic shortage in radiology services around the world. Dallas-based MedCognetics says the cloud-based AI software as a service (SaaS) has been trained on a diverse patient dataset harvested from around the world to reduce data bias, and can detect the earliest manifestations of cancer in all ethnicities. It slots into the standard radiology workflow, so the radiologist does not have to engage in any additional tasks during the process, with the AI's findings layered on top of mammography images.

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Nov 03,2022

Philips Advances MR Radiotherapy Imaging and Simulation for Head and Neck Cancers

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced two new advances in MR-only workflows to advance head and neck cancer radiotherapy imaging and simulation. The company's artificial intelligence (AI) enabled MRCAT Head and Neck radiotherapy application, which allows the use of MR as the sole or primary imaging modality for radiotherapy planning in the treatment of soft tissue tumors in the head and neck, along with the brain, pelvis and prostate, has received FDA 510(k) clearance and is commercially available in the U.S.

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May 30,2023

FDA green-lights bionic pancreas studied at UT Health Science Center San Antonio, University Health

The University of Texas Health Science Center at San Antonio and its clinical partner, University Health, have received FDA clearance for the "bionic pancreas," an AI-powered system that helps manage insulin delivery for children with type 1 diabetes. The system, paired with a continuous glucose monitoring system, relieves parents and children of the constant stress of estimating insulin doses and carbohydrate intake. The device, about the size of a cell phone, uses AI algorithms to learn the patient's insulin requirements, providing a simpler and more automated approach to diabetes management.

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May 19,2023

FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery

The U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery. The iLet Bionic Pancreas uses an adaptive closed-loop algorithm that is initialized only with a user's body weight and requires no additional insulin dosing parameters. This adaptive algorithm removes the need to manually adjust insulin pump therapy settings and variables as is needed with conventional pump therapy and is easier to initiate than other available AID systems.

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Jun 16,2021

Amalgam Rx Receives CE Mark for Basal Insulin Titration

Amalgam Rx, Inc., the leader in connecting healthcare providers and life sciences companies through a SaaS-enabled digital marketplace and product platform, is announcing it has achieved the Conformité Européenne (CE) Mark for its insulin titration application, iSage RxTM and its white-labeled variants. With this CE Mark, iSage Rx’s capacity to support the titration of all basal insulins and enable connectivity to the leading Bluetooth-enabled blood glucose meters from Roche, Lifescan, and Ascensia, is now cleared for the European market.

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