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BioWorld - Monday, December 29, 2025
Home » Topics » Medical devices » Digital health

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FDA greenlights Ultromics' AI image analysis system for cardiovascular disease

Nov. 15, 2019
By Meg Bryant
Oxford University startup Ultromics Ltd. has won the U.S. FDA's nod for its artificial intelligence (AI) image analysis system for diagnosing coronary artery disease. Called Echogo Core, the system is intended to serve as an aid to cardiologists in evaluating echocardiograms of patients referred with symptoms such as shortness of breath and chest pain. Ross Upton, co-founder and CEO of Ultromics, called the clearance a "watershed moment" for the company, which began developing its algorithm-based system in 2011 and was spun out of Oxford University in 2017. The next stage for the company is commercializing the product and bringing it to clinicians in the U.S. Ross said the company expects to launch the product in the beginning of next year.
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Scanwell Health aims to ease testing for UTIs with smartphone-enabled option

Nov. 15, 2019
By Liz Hollis
Urinary tract infections (UTIs) are a common reason for women to visit their doctor. While virtual doctor visits have been possible to detect UTIs, patient-reported symptoms typically have drove diagnoses. Now, Los Angeles-based Scanwell Health is bringing its at-home smartphone-enabled test and treatment service for UTIs to all 50 states. Scanwell said its offering its the first U.S. FDA-cleared urine testing app available over-the-counter without a prescription.
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Philips launches its first AI-based cognitive assessment product in the U.S.

Nov. 14, 2019
By Stacy Lawrence
A neuropsychologist consult is typically the first step for a neurologist in aiding in the diagnosis and monitoring of neurological conditions. But timely appointments for an assessment by these specialists can be difficult to obtain, even under the best of circumstances. To better enable neurologists to assess which patients are most in need of a consultation with a neuropsychologist, Royal Philips NV has launched an artificial intelligence (AI)-based cognitive assessment tool in the U.S. Known as Philips Intellispace Cognition, the digital, cloud-based assessment tool takes established neuropsychological tests and enables their administration by a medical assistant via a tablet in an office setting.
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NIH-backed Medicasafe aims for FDA clearance of opioid use disorder drug-device combo

Nov. 13, 2019
By Stacy Lawrence
Drug addiction has often proven resistant to the best efforts for treatment. New York-based startup Medicasafe Inc. hopes to provide another tool in the arsenal to boost opioid use disorder (OUD) treatment. Rather than send a recovering addict home every couple of weeks with an unmonitored and uncontrolled supply of buprenorphine and naloxone, it has developed a drug-device combination product that digitally enables and tracks patient retrieval of these drugs.
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Following solid quarterly results, Hologic gains FDA nod for 3Dquorum imaging tech

Nov. 13, 2019
By Liz Hollis
Marlborough, Mass.-based Hologic Inc. got good news from the U.S. FDA, which has given the green light for the 3Dquorum imaging technology, which employs Genius AI. The technology works along with Hologic's Clarity HD high-resolution imaging technology to reduce tomosynthesis image volume for radiologists by 66%, the company said.
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Observation telescope pointed at water
Megaminds in Megatrends

XR tech: Sea of opportunities ahead for the med-tech sector

Nov. 12, 2019
By Sergio Held
SAN JOSE, Costa Rica – Cross reality (XR) technology is gaining traction in the med-tech sector thanks to advancements in the virtual reality (VR), augmented reality (AR) and mixed reality (MR) fields that comprise it, triggered by a surge of investments that have driven cash flow to med-tech startups. The new technology is already impacting the health care sector.
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Virta Treatment improves type 2 diabetes in veterans

Nov. 12, 2019
By Meg Bryant
Virta Health Corp. reported 90-day data from a pilot study of its Virta Treatment for type 2 diabetes (T2D) in military veterans. Conducted jointly by Virta and the U.S. Department of Veterans Affairs (VA), the pilot shows 84% of participants who used the low carbohydrate and diabetes coaching model reduced their glycemic levels to below the diabetes threshold or experienced at least a one-point drop in HbA1c, a measure of blood sugar.
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Latest telehealth bill would dismantle some geographic restrictions

Nov. 11, 2019
By Mark McCarty
Advocates of telehealth are backing the bipartisan, bicameral Connect for Health Act of 2019, which would eliminate geographic and origination site restrictions on Medicare coverage and save billions of taxpayer dollars.
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AI the future of collapsed lung diagnosis, says Ontario lab

Nov. 8, 2019
By David Godkin
TORONTO – On average, radiology specialists diagnose fewer than 50% of cases of collapsed lung or pneumothorax using chest X-rays, said systems design engineer Hamid Tizhoosh. The Insignio system developed at Tizhoosh's Kitchener, Ontario-based Kimia Lab has gone further by identifying 75% of cases of collapsed lungs using artificial intelligence (AI) to search a database of 550,000 patients and compare 30,000 cases of pneumothorax there to X-rays of new patients with unknown conditions.
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Consortium developing AI platform for improving care of severe trauma patients

Nov. 7, 2019
By Bernard Banga
PARIS – A French research consortium bringing together the firm Cap Gemini SE, the Traumabase (traumabase.eu) network, the AP-HP group of 39 teaching hospitals in the Paris region, the École Polytechnique, the National Center for Scientific Research (CNRS) and the Ecole des Hautes Etudes en Sciences Sociales (EHESS), is developing the first AI decision-making tool for managing patients with severe trauma in their first 24 hours.
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