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BioWorld - Saturday, June 20, 2026
Home » Topics » U.S., Medical technology

U.S., Medical technology
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Coronavirus headlines

Kaiser survey provides encouraging news for med-tech industry

June 1, 2020
By Annette Boyle
The Kaiser Family Foundation (KFF) reported that 48% of U.S. adults surveyed had postponed medical care due to the COVID-19 pandemic. In good news, more than two-thirds of those who delayed care expected to get the care they have delayed over the next three months.
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Illustration of local impedance field on tissue being monitored during ablation

Boston Scientific’s Directsense cardiac ablation tool rolls out in U.S.

June 1, 2020
By Meg Bryant
Boston Scientific Corp. reported the U.S. launch of its Directsense technology, a tool to aid electrophysiologists in measuring tissue response to radiofrequency (RF) waves during cardiac ablation procedures. Approved by the FDA in April, the technology is available on the company’s Rhythmia HDx mapping system.
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Carmat’s artificial heart product image
Bioprosthetic artificial heart

Carmat obtains nod for reimbursement for its total artificial heart under innovation scheme in France

May 29, 2020
By Bernard Banga
PARIS – Carmat SA, which is based in Vélizy Villacoublay, France, reported the first implantation of its bioprosthetic artificial heart at the Heart Center of the Rigshospitalet in Copenhagen, Denmark.
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Medicare puzzle

NTAP eligibility for Sentinel, Aquabeam devices set to expire for Medicare NTAP program

May 29, 2020
By Mark McCarty
The Medicare inpatient draft is always an event due to its impact on medical technology. Now, several products soon may see their new technology add-on payments (NTAP) expire because of eligibility. The Centers for Medicare and Medicaid Services (CMS) said both Claret Medical Inc.’s Sentinel embolic protection device and Procept Biorobotics Corp.’s Aquabeam device have used up their NTAP eligibility, and hospitals may see lower rates for using those devices starting Oct. 1
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Architectural pillars

Presumption in favor of petitioner seen as most critical piece of PTO response to SAS v. Iancu

May 28, 2020
By Mark McCarty
The U.S. Patent and Trademark Office (PTO) has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner.
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Illustration of Lucid system

Neural Analytics aims robotic transcranial doppler at COVID-19 patients

May 28, 2020
By Meg Bryant
Doctors are reporting a proliferation of dangerous blood clots in the lungs and other major organs of COVID-19 patients, raising the risk of stroke and other life-threatening complications. While anticoagulant medications can reduce that risk, patients need careful monitoring to ensure their blood is neither too thick nor too thin. To that end, Los Angeles-based startup Neural Analytics Inc. is deploying its robotically assisted transcranial doppler (TCD) system for real-time identification of blood clots and disruptions in blood flow to the brain.
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Rewalk Robotics sees impact of COVID-19 in first-quarter results

May 28, 2020
By Liz Hollis
Like many companies, Rewalk Robotics Ltd. saw its financials hit by the COVID-19 pandemic. It revealed May 28 that its total revenue for its first quarter fell to $0.8 million, down from $1.6 million during the same period last year. The company, which focuses on solutions that give gait training and mobility for individuals with lower limb disabilities, acknowledged the effects of the pandemic, noting that several Rewalk Personal 6.0 devices were not delivered as a result.
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Artist’s rendering of patient lying on Izotropic’s 3D breast CT scanning platform

Izotropic, Starfish set to commercialize new breast CT system

May 28, 2020
By David Godkin
TORONTO – Vancouver, British Columbia-based Izotropic Corp. has inked a deal with Victoria, British Columbia-based based Starfish Medical Inc. to commercialize a CT scanner Izotropic CEO Robert Thast said will be a major disruptor of the breast imaging industry. Izotropic has spent approximately $20 million over the past 15 years to develop the system and is counting on Starfish to help translate this into a market-ready 3D breast CT imager by the end of 2020.
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U.S. Capitol building

U.S. HHS projects national daily COVID-19 testing needs at 300,000, but Democrats unimpressed

May 26, 2020
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) has posted a national COVID-19 testing strategy in response to legislation passed in April, and the plan suggests that 300,000 tests per day should suffice to corral the pandemic. That calculation drew immediate fire from House and Senate Democrats, who characterized the plan as an attempt “to paint a rosy picture about testing,” but they also pushed the Senate to pass House legislation that would provide another $75 billion in funding for testing and contact tracing.
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U.S. FDA headquarters

FDA says 28 serology tests withdrawn or pulled from availability in the U.S.

May 22, 2020
By Mark McCarty
The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”
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