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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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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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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Sep 22,2022

Better Therapeutics submits FDA de novo request for type 2 diabetes treatment

Better Therapeutics announced today that it submitted a de novo classification request to the FDA for its BT-001 technology.

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Jan 24,2019

BD Launches Ergonomic Pen Needle Technology to Help Optimize Injection Technique

BD (Becton, Dickinson and Company) a leading global medical technology company, announced the U.S. Food and Drug Administration 510(k) clearance of its second generation BD Nano(TM) pen needle, designed for more reliable subcutaneous injection depth.

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Feb 19,2019

FDA grants De Novo clearance to interoperable insulin pump

The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of a new medical device category called Alternate Controller Enabled (ACE) infusion pumps. Intended for use by both adults and children with diabetes, the digital device automatically receives insulin dosing commands from a diabetes management device once connected, or can independently infuse insulin when it is on its own.

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Feb 25,2019

Hygieia's cloud-based insulin titration app wins 510(k) clearance

Earlier this month, Hygieia’s d-Nav Insulin Guidance Service — an app that titrates insulin doses for individual Type 2 diabetes patients, regardless of their regimen type — received 510(k) clearance from the FDA.

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Feb 14,2019

t:slim X2 Insulin Pump First to Receive New ACE Pump Classification by FDA

Tandem Diabetes Care, Inc., a leading insulin delivery and diabetes technology company, today announced that the U.S. Food and Drug Administration (FDA) has classified the t:slim X2™ insulin pump as the first in a new device category called Alternate Controller Enabled Infusion Pumps (ACE pumps). Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance. The approved indication for the t:slim X2 pump states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

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Feb 19,2019

Medtronic Receives FDA Breakthrough Designation for Developing Personalized Closed Loop Insulin Pump System for Diabetes Management

Medtronic plc, the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Personalized Closed Loop (PCL) insulin pump system, currently in development. The PCL technology is designed to automate insulin delivery in a way that is real-time, personalized and adapts to the user. The system will also provide insights and predictive diagnostics unique to the individual, with a goal of dramatically simplifying diabetes management for the patient. The recent acquisition of Nutrino Health and their expertise in nutrition data science will play a key role in the accelerated development of this breakthrough technology.

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