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

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

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 • 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 • 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

Tandem's insulin dosing algorithm OK'd for use in younger kids

FDA's decision to expand the pediatric indication was supported by an NIH-funded trial that found the automated insulin dosing system helped improve time in range for children ages 6 to 13.

By Maria Rachal • June 17, 2020

Thermo Fisher, MedRhythms gain breakthrough device designations

A companion diagnostic for certain brain tumor patients and a digital therapeutic for stroke patients with walking impairments are among the latest technologies tapped by FDA for the priority review program.

By Susan Kelly • June 17, 2020

FDA revokes emergency authorization for Chembio's COVID-19 antibody test

It's the first time the agency has exercised such authority for a coronavirus test, citing more false results than expected. Chembio Diagnostics' stock plunged 60% Wednesday.

By Greg Slabodkin • June 17, 2020

In FDA 1st, game-based therapeutic gets marketing OK

Digital therapeutics developer Akili Interactive Labs won De Novo authorization for a treatment meant to improve attention function in children with ADHD, building on a rollout it began under a special COVID-19 policy.

By Maria Rachal • June 16, 2020

Heart rhythm bodies see 'clear concerns' with using wearables to detect arrhythmias

A paper published on Monday by the Heart Rhythm Society, along with counterpart groups in Asia, Europe and Latin America, found wearable-triggered false positives can cause unwarranted concerns and screening.

By Nick Paul Taylor • June 16, 2020

Labs urge CDC to change COVID-19 antibody test guidelines

The trade group for Quest Diagnostics and LabCorp criticized the federal agency's advice against use of serology test results to make decisions about who can return to work.

By Nick Paul Taylor • June 16, 2020

Paclitaxel-coated balloon, stent labels in Europe to have mortality warning update

A notice posted by British medical device regulators outlined 12 affected products including Boston Scientific's ELUVIA stent, Cook Medical's Zilver PTX stent, and Medtronic's IN.PACT Admiral balloon.

By Greg Slabodkin • June 15, 2020

Abbott's FreeStyle Libre 2 gets long-awaited iCGM nod from FDA

The designation may stiffen competition for Dexcom, whose G6 device was the sole integrated continuous glucose monitor on the U.S. market. But Abbott's device isn't yet OK'd for use with automated insulin dosing systems.

By Nick Paul Taylor , Maria Rachal • June 15, 2020

CMS to review at-home ventilation of COPD patients amid variability in device use

Findings from a July Medicare Evidence Development & Coverage Advisory Committee meeting and resulting policy changes could potentially impact ResMed and Philips Respironics.

By Nick Paul Taylor • June 12, 2020

MedTech Europe pitches virtual audits to clear MDR coronavirus logjam

The trade group contends technology such as smart glasses and webcams can enable notified bodies to view facilities without having to visit in person.

By Nick Paul Taylor • June 11, 2020

Ex-FDA chief scientist slams 'chaos' caused by agency approach to antibody tests

Jesse Goodman said the agency’s decision to allow developers of COVID-19 serology tests to self-validate their products led unqualified entities to flood the market.

By Nick Paul Taylor • June 10, 2020

Edwards wins approval to introduce Sapien 3 valve in China

The transcatheter heart device specialist has been eyeing the wealthy, aging nation's untapped market potential for new cardiovascular disease treatments.

By Susan Kelly • June 9, 2020

Lawmakers push HHS to funnel funds to clinical labs amid routine testing decline

Members of Congress on both sides of the aisle argue the investments laboratories are making to scale up COVID-19 testing mean they need more targeted financial support, which should come out of a $25 billion relief fund.

By Nick Paul Taylor • June 9, 2020