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BioWorld - Monday, December 15, 2025
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Acumen HPI software screenshot

FDA OKs Edwards’ HPI software with noninvasive Acumen IQ cuff

June 2, 2021
By Meg Bryant
Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs.
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Scientists in lab using BD's urine culture analysis imaging application

BD launches AI-powered urine culture analysis application

June 1, 2021
By Ana Mulero
Becton, Dickinson & Co. (BD) is looking to ease the burden on microbiology labs with the U.S. launch of its urine culture analysis imaging application by automating microbiology processes. Powered by artificial intelligence (AI), the app is intended for use on the device manufacturer’s Kiestra lab automation incubation and imaging system.
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Cancer diagnostic illustration

Ibex secures CE mark for use of Galen AI system in breast cancer detection

May 26, 2021
By Nuala Moran
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer.
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Three steps for getting checked for visual field defects with Heru

Heru closes $30M series A to advance wearable vision technology

May 20, 2021
By Meg Bryant
Heru Inc. has raised $30 million in a series A financing to support the further development of its artificial intelligence (AI)-enabled, wearable eye diagnostic and vision correction platform. D1 Capital Partners led the round, with participation from Softbank Ventures Opportunity Fund, Maurice Ferre, Frederic Moll, Krillion Ventures and a consortium of investors with expertise in developing, launching and scaling medical technologies.
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Smartphone showing One Drop app

One Drop wins CE mark for glucose prediction tool

May 14, 2021
By Meg Bryant
Information Data Systems Inc., doing business as One Drop, has earned the CE mark for its blood glucose prediction analysis engine to accurately forecast glucose levels up to eight hours in advance. The artificial intelligence (AI)-powered tool is indicated for people living with prediabetes, type 2 diabetes, including those on oral medications and/or insulin regimens, and gestational diabetes.
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Aman Kant, chief business officer, Inveniai

Shionogi bags agreement for Inveniai’s AI drug discovery platform Alphameld

May 4, 2021
By Gina Lee
HONG KONG – Shionogi & Co. Ltd. has inked a multitarget drug discovery collaboration for Inveniai LLC’s artificial intelligence and machine learning platform Alphameld.
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Aman Kant, chief business officer, Inveniai

Shionogi bags agreement for Inveniai’s AI drug discovery platform Alphameld

April 29, 2021
By Gina Lee
HONG KONG – Shionogi & Co. Ltd. has inked a multitarget drug discovery collaboration for Inveniai LLC’s artificial intelligence and machine learning platform Alphameld. Inveniai is eligible to receive up to $200 million per program through a combination of up-front payments, development and commercial milestones, and royalties.
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Lung illustration

FDA clears Nines’ AI-based lung nodule measurement tool

March 30, 2021
By Meg Bryant
Teleradiology company Nines Inc. won 510(k) clearance from the FDA for Ninesmeasure, an artificial intelligence (AI)-powered tool for measuring lung nodules. The Palo Alto, Calif.-based company says the new tool can help speed the diagnosis of certain respiratory diseases, resulting in better patient outcomes.
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Brain illustration

Brainscope goes to full launch with new Concussion Index

March 23, 2021
By Mark McCarty
Although artificial intelligence (AI) seems to be making only incremental headway in the world of medical technology, Brainscope Co. Inc., continues to advance its AI offerings with the launch of the Concussion Index (CI). This algorithm, used with the company’s disposable headset, has been demonstrated to reduce the need for cranial CT scans by 30%, making this a double win for patients and for health care spending in the U.S.
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DNA data illustration

Whitelab joins forces with Genethon to enhance gene therapy

March 22, 2021
By Bernard Banga
PARIS – Whitelab Genomics SAS has signed a partnership agreement with Genethon, a French research center in the field of gene therapy, to ramp up development of genetic therapy techniques using artificial intelligence (AI). As part of this partnership, Genethon will use the Whitelab Genomics Catalyst platform to develop new capsids.
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