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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

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

Surmodics gets CE mark for Abbott-backed paclitaxel-coated balloon

The company will receive a $10.8 million milestone payment from Abbott, which licensed exclusive commercialization rights to the device for peripheral artery disease patients in 2018 in a bid to take on Medtronic's drug-coated balloons.

By Maria Rachal • June 8, 2020

COVID-19 false negatives fuel call for urgent focus on asymptomatic patients

Harvard and Yale physicians writing in the New England Journal of Medicine called for development of a reference standard for measuring sensitivity of coronavirus tests in those without symptoms who may infect others.

By Nick Paul Taylor • June 8, 2020

FDA warns of cyanide gas risk with certain media if used with Hologic coronavirus test

The agency alerted clinical labs and healthcare providers to the potential for bleach to react with guanidine materials and produce deadly gas, making it unsafe to use some transport media with Hologic’s assays.

By Nick Paul Taylor • June 5, 2020

Months into pandemic, Trump admin mandates labs report demographic data of COVID-19 tests

HHS is now requiring labs to submit a much broader range of data related to testing. However, the American Clinical Laboratory Association said it's difficult for labs to get information to public health agencies without help from providers.

By Rebecca Pifer Parduhn • June 4, 2020

European Commission lays out timeline for next steps toward MDR, IVDR

Targets for issuing upcoming implementing acts, including those on reprocessing single-use medical devices and the delayed Eudamed database, range from the coming quarter to two years from now.

By Nick Paul Taylor • June 4, 2020

PMA major deficiency letters tick up, 510(k) asks for info flatline: MDUFA report

FDA's second quarter report for fiscal 2020, which covered January through March, also showed that the agency still has many guidance document priorities to check off its list.

By Maria Rachal • June 4, 2020

CMS relaxes more value-based model rules in wake of pandemic

Payments and reporting rules related to joint replacements, end stage renal disease and diabetes care were among those addressed.

By Shannon Muchmore • June 3, 2020