Mar 08,2023

DIGITAL THERAPEUTICS STARTUP RESPIREE™ GAINS US FDA CLEARANCE FOR ITS RS001 CARDIO-RESPIRATORY WEARABLE

Digital therapeutics startup, Respireetm, has received clearance from the US Food and Drug Administration (FDA) for its RS001 cardio-respiratory wearable, according to a press release. The wearable device measures respiration directly and can be used on patients suffering from cardio-pulmonary diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure. The collected data is then transmitted to healthcare providers, who can use it to monitor patients remotely and provide real-time interventions. The FDA clearance is a significant milestone for Respireetm, allowing the company to market and distribute the RS001 wearable in the US. This approval highlights the growing trend towards remote patient monitoring and digital health solutions.

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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 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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Apr 25,2023

Insulet Announces FDA Clearance of Omnipod GO™, a First-of-its-Kind Basal-Only Insulin Pod, Further Simplifying Life for People with Type 2 Diabetes

Insulet Corporation announced the FDA clearance of its latest innovation, Omnipod GO™, an insulin delivery device cleared for use for people with type 2 diabetes age 18 or older who would typically take daily injections of long-acting insulin. Omnipod GO is a standalone, wearable, insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. It has been cleared for use with the following U-100 insulins: NovoLog®, Fiasp®, Humalog®, Admelog®, and Lyumjev®. The product was developed to serve people with type 2 diabetes earlier in their treatment journey by starting them on Pod therapy for their insulin delivery, rather than daily injections. Insulet plans to commercialize Omnipod GO in the United States in 2024.

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Apr 21,2023

FDA Approves Medtronic MiniMed™ 780G System - World's First Insulin Pump with Meal Detection Technology* Featuring 5-Minute Auto Corrections†§

Medtronic announced U.S. FDA approval of its MiniMed™ 780G system with the Guardian™ 4 sensor requiring no fingersticks while in SmartGuard™ technology. The system provides insulin to help account for when users occasionally forget to bolus or underestimates the number of carbs in their meal. This milestone marks the approval of the only system with meal detection technology that provides automatic adjustments and corrections to sugar levels every 5 minutes

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