As LabCorp, Quest feel COVID-19 strain, Trump admin pegs hopes on POC tests

Brett Giroir, the administration's lead for coronavirus diagnostics, said the goal is for rapid point-of-care tests from Abbott, BD and Quidel, performed outside of lab settings, to alleviate commercial testing capacity constraints.     

By Greg Slabodkin • July 8, 2020

Newest Medtronic implantable heart monitor gets FDA nod as remote device features proliferate

The U.S. marketing clearance comes on the heels of an FDA nod for Boston Scientific's LUX-Dx insertable cardiac monitor, which also can be programmed remotely by a physician.

By Susan Kelly • July 8, 2020

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

'If the public knew:' Ripple20 shows medical device software cyber weakness

Last month’s discovery that Baxter and B. Braun infusion pumps face risk of remote attacks by hackers comes as a medtech effort gains momentum to track third-party components in devices.

By Greg Slabodkin • July 7, 2020

FDA warns of false positives with BD coronavirus diagnostic

On the heels of greenlighting BD's antigen test, FDA flagged an issue with its molecular test offering, telling healthcare professionals to treat positive results as “presumptive” and consider confirming findings via a different test.

By Nick Paul Taylor • July 7, 2020

OTC hearing aid proposal, EtO sterilizer rule make 2020 regulatory agenda

Federal agencies also aim by year's end to issue updates to radiological health regulations, changes to the De Novo application process and modifications to streamline Medicare coverage of breakthrough technologies.

By Maria Rachal • July 2, 2020

FDA delays UDI enforcement amid COVID-19, ongoing technical issues

The agency is holding off on enforcing unique device identification regulations until September 2022, four years later than was originally planned.

By Nick Paul Taylor • July 2, 2020

CMS proposes major market expansion in potential boost for Abbott's MitraClip

Analysts at Cowen estimate the agency's proposal could double or triple the number of U.S. mitral regurgitation patients eligible for the treatment.

By Nick Paul Taylor • July 1, 2020

Notified body poll finds multi-month waits for COVID-19 conformity assessments

More than half surveyed by the European Commission expect to spend six months to a year processing applications for certain devices addressing coronavirus.

By Nick Paul Taylor • July 1, 2020

HHS 'expects to renew' COVID-19 emergency, spokesperson says

The department did not respond to requests for comment Tuesday morning. The public health emergency is currently set to expire at the end of July.

By Shannon Muchmore • June 30, 2020

As Beckman enters US COVID-19 antibody market, how do rivals compare?

Comparing the accuracy of the Danaher subsidiary's test to products from big rivals like Abbott, Roche and Siemens Healthineers depends on who's doing the assessment and when a sample is taken.

By Nick Paul Taylor • June 30, 2020

FDA nod to Boston Scientific cardiac monitor clears challenge to Abbott, Medtronic

The medtech giant is betting remote adjustment will put its LUX-Dx insertable system in a position to take on rivals, which have a years-long head start.

By Nick Paul Taylor • June 29, 2020

Texas again halts elective surgeries, showing fragile nature of rebound

The renewed restrictions spurred questions about whether states or individual health systems in other hotspots like Arizona and California will enforce similar pullbacks in procedures.

By Maria Rachal • June 26, 2020

CMS wants to make home health telemedicine permanent after COVID-19

Agencies would be able to keep using the tech for beneficiaries under the Medicare home health benefit beyond the public health emergency, including remote patient monitoring, according to a proposed rule fact sheet.

By Rebecca Pifer Parduhn • June 26, 2020

Payer coverage of employer, surveillance COVID-19 tests not required, feds say

As return-to-work offerings proliferate from lab and pharmacy giants like Quest, LabCorp and CVS, new federal guidance says health insurers aren't obligated to pay for the testing services.

By Maria Rachal • June 25, 2020

FDA signals support for automated insulin dosing tech, backing new development tool

As the diabetes technologies meet regulators' safety and efficacy benchmarks, the agency wants to help developers assess patient and family-reported quality of life factors.

By Maria Rachal • June 25, 2020

UK study to validate, compare COVID-19 tests in real-world settings

The hospital arm will assess 10 to 20 new diagnostics the National Health Service has identified as high priority, including those designed to deliver results at the point of care in minutes, which could include Abbott’s ID NOW.

By Nick Paul Taylor • June 25, 2020

Fauci: Trump never asked to slow down testing, says US needs more, not less

During a House panel Tuesday, top U.S. infectious disease doctor Anthony Fauci and other public health officials denied they'd been directed to impede testing efforts as the White House targets up to 50 million tests a month by fall.

By Rebecca Pifer Parduhn • June 24, 2020

Medtronic Evolut TAVR system gets expanded label in Europe

New indications allow a less-invasive alternative to traditional open heart surgery for a group of severe aortic stenosis patients who tend to be younger and more active, and in higher-risk patients with bicuspid aortic valves.

By Susan Kelly • June 23, 2020

FDA affirms potential to miss MDUFA deadlines, weighs virtual advisory panels

Separately, the agency announced virtual meetings in September on using patient preference information in medical device regulatory decisions and considering patient-reported outcomes in evaluating devices.

By Nick Paul Taylor • June 23, 2020

Mainstay wins FDA approval for chronic back pain device following mixed clinical data

The premarket approval comes 19 months after the ReActiv8 neurostimulation system failed a clinical trial aimed at generating data to break into the U.S. market.

By Nick Paul Taylor • June 23, 2020

Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says

The agency has grappled with how to leverage real-world data in regulating medical devices, and is now leaning on it to update emergency use authorizations, FDA chief Stephen Hahn said at a forum on Thursday.

By Maria Rachal • June 19, 2020

Lack of data encryption for Baxter devices flagged in flurry of DHS alerts

The Department of Homeland Security's cyber agency published four advisories, ranging from 7.5 to 8.6 on its 10-point severity scale, about vulnerabilities in infusion pumps, hemodialysis delivery systems and other tech.

By Nick Paul Taylor • June 19, 2020

Senators back sustaining telehealth momentum post pandemic

Top priorities include axing geographic restrictions, expanding Medicare and Medicaid reimbursement for virtual care services, and upping use of remote patient monitoring and digital health tools for patients with chronic conditions.

By Rebecca Pifer Parduhn • June 18, 2020

FDA cracks down on sellers of at-home COVID-19 antibody tests

A series of warning letters is the latest example of U.S. regulators weeding out serology tests that don't meet the agency's standards.

By Nick Paul Taylor • June 18, 2020

TÜV SÜD becomes 4th notified body designated under IVDR

It's the first notified body OK'd by the European Commission in 2020 to increase capacity for the forthcoming In Vitro Diagnostic Regulation, set to come into force in less than two years.

By Nick Paul Taylor • June 18, 2020