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BioWorld - Thursday, May 7, 2026
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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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FDA briefing docs stir feeding frenzy for Amarin's Vascepa

Nov. 13, 2019
By Mari Serebrov
The fish were biting Tuesday at Amarin Corp., as the FDA released its briefing documents for Thursday's advisory committee review of a first-of-its-kind indication for the company's fish oil-based Vascepa.
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Emory study floats new method for predicting pacemaker in TAVR

Nov. 12, 2019
By Mark McCarty
Patients undergoing transcatheter aortic valve implant may need a pacemaker after the TAVR device, but a new study suggests that right bundle branch block may predict the need for pacing. The data may have implications for device selection as some devices are seen as less likely to trigger the need for a pacemaker, a development that may move the needle in the robust but increasingly competitive market for TAVR.
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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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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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Fight over HHS' PrEP patents becoming a two-front battle

Nov. 8, 2019
By Mari Serebrov
Bowing to congressional pressure, the U.S. Department of Health and Human Services (HHS) Wednesday filed suit against Gilead Sciences Inc. for infringing government patents related to the use of HIV drugs Truvada and Descovy for pre-exposure prophylaxis (PrEP).
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Taken together, U.S. drug prices trending downward

Nov. 7, 2019
By Mari Serebrov
Whether prescription drug prices are skyrocketing in the U.S. is a question of perspective and context. Patients needing regular refills of insulin or certain other brand drugs with no generics are seeing their out-of-pocket costs going up, sometimes with every trip to the pharmacy.
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Second Circuit: U.S. antitrust law doesn't reach intent in global Rx shenanigans

Nov. 6, 2019
By Mari Serebrov
Those cheap prescription drug prices other countries get? They're not always the result of savvy government negotiations. An antitrust suit the U.S. Court of Appeals for the Second Circuit dismissed Tuesday alleges that some of those low prices may be innovator shenanigans intended to prevent or delay biosimilar competition in the U.S. market.
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Court says PTAB appointment process is unconstitutional

Nov. 5, 2019
By Mark McCarty
The U.S. Court of Appeals for the Federal Circuit has decreed that the regulations governing appointment of judges to the Patent Trial and Appeal Board (PTAB) violate the U.S. Constitution – a decision that gives a medical device maker a new bite at patent litigation, but which also raises the question of whether a large number of PTAB decisions will have to be relitigated.
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