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BioWorld - Thursday, April 9, 2026
Home » Topics » North America » U.S.

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Early cavity detection (ECD) system product image

Ortek fills cavity in dental care with early caries detection system

May 21, 2020
By Annette Boyle
Ortek Therapeutics Inc., of Roslyn Heights, N.Y., has officially launched its electronic early cavity detection system, the Ortek-ECD. The U.S. FDA-cleared device can detect dental lesions before they show up on X-rays, enabling less invasive treatment and preventing greater damage to the tooth structure. Ortek holds the exclusive license for the device which was developed at Stony Brook University School of Dental Medicine.
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FDA’s Stenzel: Abbott agrees to new study for ID Now test for COVID-19

May 20, 2020
By Mark McCarty
The FDA’s response to the COVID-19 pandemic has been matched by device makers, but the ID Now molecular test by Abbott Park, Ill.-based Abbott Laboratories has been the target of recent criticism. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, said at a May 20 town hall meeting that Abbott has agreed to yet another study of the ID Now, the terms of which were under negotiation at the time of the meeting.
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Digital illustration of U.S., coronavirus

As pandemic continues, Proscia offers digital pathology software for remote use in clinical practice

May 20, 2020
By Liz Hollis
Proscia Inc., a Philadelphia-based company that focuses on artificial intelligence (AI)-enabled digital pathology solutions, recently made the Concentriq Dx digital pathology software available for use in reviewing and reporting of digital pathology slides in the U.S. during the COVID-19 pandemic.
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Tearcare system components

Sight Sciences highlights positive results from Tearcare

May 18, 2020
By Liz Hollis
Dry eye disease is a common problem, and Sight Sciences Inc., of Menlo Park, Calif., is looking to help those who suffer from the condition. Now, the company has seen the presentation of positive clinical data from the multicenter OLYMPIA study of Tearcare, which the company has heralded as the first wearable and intelligent eyelid technology for dry eye treatment.
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Testing being performed on Abbott's ID Now system

Abbott pushes back on Langone study of ID Now test; FDA cites possibility of swab, transport media issues

May 15, 2020
By Mark McCarty
Abbott Laboratories’ ID Now test for the SARS-CoV-2 virus made waves when it was introduced thanks to the rapid turnaround time the molecular test promised. But questions about the test’s performance have surfaced several times in recent weeks. The latest criticism comes from a study conducted at the New York University Langone Medical Center, which claims the diagnostic compared poorly against a competitor. However, the U.S. FDA said that it has questions about the swabs and transport media used in connection with the test. As a result, it will stand pat regarding the ID Now’s place in the emergency use authorization (EUA) program.
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Richard Bright testifying before House subcommittee

Bright warns of ‘darkest winter in modern history’

May 14, 2020
By Mari Serebrov
“Our window of opportunity is closing. If we fail to develop a national coordinated response, based in science, I fear the pandemic will get far worse and be prolonged, causing unprecedented illness and fatalities,” Rick Bright, former director of the Biomedical Advanced Research and Development Authority, said today as he testified at a House subcommittee hearing on the U.S. response to COVID-19.
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Surgeon using the ORlenz headset

Ocutrx debuts AR-based system for surgical visualization

May 14, 2020
By Meg Bryant
Irvine, Calif.-based startup Ocutrx Vision Technologies LLC unveiled new technology that it said helps surgeons better visualize the operative field during surgical procedures. The OR-Bot Surgery Visualization Theatre combines augmented reality (AR), virtual reality (VR) and both human- and robot-controlled arms to facilitate exacting medical procedures without the need for physicians to look away from the patient.
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Patent gears

PTO offers priority for pandemic-related patents, but time of the essence

May 14, 2020
By Mark McCarty
The U.S. Patent and Trademark Office (PTO) has opened a priority track for patents related to the COVID-19 pandemic, another signal of federal government intent on overcoming this new plague. However, Scott Marty, a partner with the Atlanta office of Ballard Spahr LLP, told BioWorld that while the program offers some distinct advantages for pandemic-driven patents, inventors should have their filings in good form before entry because any delays incurred by a less-than-airtight application could lead the PTO to boot the application out of this program.
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Physician using an Ipad

Nanthealth looks to help cancer patients during pandemic

May 13, 2020
By Liz Hollis
How is the COVID-19 pandemic affecting cancer treatment plans? Oncologists are weighing switching treatment plans, and they have many questions. That’s where Nanthealth Inc., of El Segundo, Calif., is looking to help.
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Digital illustration of U.S., coronavirus
World Medical Innovation Forum

U.S. COVID-19 Dx: Lack of centralization meets flourishing innovation, as disorder prevails

May 13, 2020
By Stacy Lawrence
The U.S. does not have a universal health care system, which means that it fails to provide a consistent level of minimum care across its population. That means that basic and preventative care often falls through the cracks, even as the U.S. continues to excel at medical innovation and offer the most highly regarded health care in the world to those who can afford it.
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