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BioWorld - Monday, April 20, 2026
Home » Topics » U.S., Medical technology

U.S., Medical technology
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Össur and AMF planning trials of IMES system in mind-controlled prosthetics

Nov. 11, 2019
By Annette Boyle
The Alfred Mann Foundation (AMF) and Össur have signed an agreement that will allow Reykjavik, Iceland-based Össur to further develop and license the implanted myoelectric sensor (IMES) system developed by AMF. Both organizations expect clinical trials to begin within the year.
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Dexcom sees 3Q revenue soar 49% to $396.3M

Nov. 11, 2019
By Meg Bryant
Diabetes management company Dexcom Inc. trounced Wall Street forecasts for the third quarter of 2019, with the company reporting worldwide sales of $396.3 million, up 49% from $266.7 million in the same period of 2018. Dexcom officials attributed the surge to volume growth plus new patient additions as providers and consumers become more aware of the benefits of real-time continuous glucose monitoring (CGM), where Dexcom's G6 has seen steady demand since launching in June 2018.
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Pilot study finds AI algorithm bests surgeons in post-op triage to the ICU

Oct. 31, 2019
By Stacy Lawrence
Deciding which patients should go into the intensive care unit (ICU) after surgery is a difficult call and typically made entirely at the surgeon's discretion. The result is that surgeons typically err on the side of caution by putting more post-operative patients in the ICU than necessary. To aid in better ICU decision-making, physicians at New York University Langone Hospital System (NYU Langone) developed a machine learning algorithm that combs through a patient's electronic medical record to identify relevant factors to determine if they needed the ICU after surgery.
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Veracyte touts early results in nasal swab test for early lung cancer detection, revenue up to $31M

Oct. 29, 2019
By Meg Bryant
Genomic testing firm Veracyte Inc. is eyeing 2021 for the launch of its noninvasive nasal swab classifier for early lung cancer detection and diagnosis, following preliminary clinical data demonstrating high sensitivity in low-risk patients and high specificity in high-risk patients with known lung nodules. The South San Francisco-based company is developing the nasal swab test in collaboration with Johnson & Johnson Inc.'s Lung Cancer Initiative, part of a long-term strategic collaboration that also aims to speed commercialization of Veracyte's Percepta genomic sequencing classifier.
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2019 Medical Innovation Summit

Mitral valve surgery, osteoporosis drug top Cleveland Clinic's annual list

Oct. 24, 2019
By Liz Hollis
CLEVELAND – The list is out, and a dual-acting osteoporosis drug and a device for expanding the use of minimally invasive mitral valve surgery have come out on top. That's according to a panel of doctors and researchers who develop the highly anticipated Top 10 annual list of medical innovations looking to transform patient care, revealed at the Cleveland Clinic's Medical Innovation Summit.
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UCSF, Berkeley researchers develop brain bleed algorithm that bests expert radiologists

Oct. 23, 2019
By Stacy Lawrence
Radiologists review thousands of images a day. The hope is that artificial intelligence (AI) applications will become useful soon to verify diagnoses, prioritize queued images and even to offer a level of detection and measurement that aren't feasible for humans. One of the latest efforts on this front is by researchers at the University of California at San Francisco (UCSF) and the University of California at Berkeley.
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MAUDE takes another hit over adverse events for Sapien 3, Mitraclip

Oct. 23, 2019
By Mark McCarty
A recent medical journal article says the terminology used by physicians to denote a fatality in the FDA adverse event reporting system has led to underreporting of fatalities associated with two prominent cardiology devices, a predicament the authors say skews the public understanding of these devices' safety profiles.
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Philips, DoD develop AI-based predictive algorithm for early infection detection

Oct. 23, 2019
By Meg Bryant
Diagnosis and treatment of infections typically occurs after people exhibit obvious signs of illness, such as fever or a cough. By then, they may already have exposed others and are well on the way to developing more serious symptoms themselves. In the military, such delays can hamper medical countermeasures to contain potential outbreaks and reduce downtime among active duty personnel. Now, Amsterdam-based Royal Philips NV and the U.S. Department of Defense's Defense Threat Reduction Agency and Defense Innovations Unit have built an early warning algorithm – using artificial intelligence – to detect infection before a person shows any signs or symptoms of infection.
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Little predictability in IRB use of 'appropriate local committees'

Oct. 22, 2019
By Mark McCarty
The FDA's September 2019 final guidance for the humanitarian device exemption program brought some clarity to several issues, but device makers must still untangle the question of which tasks an institutional review board (IRB) has delegated to an appropriate local committee for a specific clinical site.
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Canon Medical nabs FDA OK for AI-enhanced Aquilion Precision CT

Oct. 22, 2019
By Meg Bryant
The U.S. FDA has given 510(k) clearance to the Advanced Intelligent Clear-IQ Engine (AiCE) for Canon Medical Systems USA Inc.'s Aquilion Precision CT scanner. The regulatory green light brings artificial intelligence (AI)-based image reconstruction capabilities to the world's first ultra-high resolution CT imaging system.
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