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BioWorld - Thursday, January 15, 2026
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Antibodies fighting coronavirus

Adaptive, Microsoft launch open database of immune response by COVID-19 patients

June 11, 2020
By Stacy Lawrence
Partners Adaptive Biotechnologies Corp., which is based in Seattle, and Redmond, Wash.-based Microsoft Corp. have started sharing an open database that details the immune response in COVID-19 patients with researchers and public health officials. The project is analyzing thousands of de-identified patient blood samples submitted from institutions around the world and is dubbed ImmuneCODE.
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Shipping container with flag of China

Beijing export officials using black, whitelists to determine exportability of test kits

June 10, 2020
By Mark McCarty
The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program.
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U.S. Capitol building

Senator: Now’s the time to plan for next pandemic

June 10, 2020
By Mari Serebrov
Before the lessons of COVID-19 fade into yesterday’s news, Congress should start preparing for the next pandemic, Sen. Lamar Alexander (R-Tenn.) is advising. As the chair of the Senate Health, Education, Labor and Pensions Committee, the senator issued a white paper Tuesday identifying areas that must be addressed.
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Digital illustration of U.S., coronavirus

U.S. federal government eyes private sector role in strategic stockpile management

June 9, 2020
By Mark McCarty
Rear Admiral John Polowczyk, vice director of logistics for the Joint Chiefs of Staff, said in a Senate hearing that the one solution to managing pandemic supplies might be to use federal taxpayer dollars to sustain inventories in private-sector warehouses.
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Glass vial production line

Supply shortages continue to threaten pandemic response

June 4, 2020
By Mari Serebrov
During a massive disaster or a pandemic, securing the necessary manufacturing capacity, needles, syringes, vials, properly labeled caps, reagents and other supplies is as critical as the development of the product itself. Some experts have been warning about these needs since COVID-19 first began spreading outside of China. Now members of Congress are sounding the alarm.
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Dilumen product image

Lumendi sees first incisionless appendectomy using its double-balloon EIP

June 3, 2020
By Liz Hollis
Westport, Conn.-based Lumendi LLC revealed that the first endoscopic appendectomy has taken place using its Dilumen Endolumenal Interventional Platform (EIP). The procedure represents a change from traditional appendectomies, which are performed through open or laparoscopic surgery, requiring an incision of the abdominal wall.
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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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