Policy & Regulation: Page 2

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 09, 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 09, 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 08, 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 08, 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 05, 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 • June 04, 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 04, 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 04, 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 03, 2020

Fitbit, NASA get latest FDA emergency authorizations for ventilators

Fitbit's invention is considered an emergency resuscitator, the same label given to a device manufactured by Boston Scientific. NASA's breathing machine builds on a version of a full-fledged ventilator that gained FDA's OK in April.  

By Nick Paul Taylor • June 03, 2020

Four deaths trigger Class I recall for parts of Medtronic's HeartWare system

The FDA issued the safety alert Thursday, its second in quick succession. The ventricular assist device has been the subject of more than a dozen such high-risk recall notices since 2014.

By Nick Paul Taylor • May 29, 2020

EU group sets path for pre-MDR notified body renewal, coronavirus-era surveillance

A new guidance applies to designating authorities and medical device sector notified bodies whose designations would have expired between this week and the Medical Device Regulation's delayed go-live date next May.

By Maria Rachal • May 28, 2020

Emergency authorization granted to COVID-19 ICU prediction software

The FDA nod for CLEW Medical's system is among a series of regulatory OKs for products designed to inform care for infected patients.

By Nick Paul Taylor • May 28, 2020

FDA offers reference panel to validate coronavirus tests amid false negatives

The aim is to aid commercial and lab developers in ensuring diagnostic testing quality with independent performance validation. Recent studies flagged double-digit rates of false negatives among such tests.

By Nick Paul Taylor • May 28, 2020

FDA Breakthrough Devices Program nears 300 designations

The agency has tapped 50 devices so far this year, with recent nods to Orteq, Thermedical, ArcherDX, Helius, PhotoPharmics and Terumo.

By Susan Kelly • May 27, 2020

CDC seeks to limit false positives with COVID-19 antibody testing, as immunity question lingers

The interim guidelines promote using high-specificity assays and conducting confirmatory tests when appropriate. However, the agency won't yet use serologic test results to sway public health recommendations.

By Nick Paul Taylor • May 27, 2020

FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions

Companies that market medical devices under premarket approvals or humanitarian device exemptions can make limited modifications to design and production without giving prior notice, according to special guidance.

By Nick Paul Taylor • May 22, 2020

Abbott, Roche ink deals with UK for 10M coronavirus antibody tests

The notice from the government, which bought $20 million in unreliable antibody tests early in the crisis, came as FDA removed 28 products from a list of the tests that can be used without emergency use authorizations.

By Nick Paul Taylor • May 22, 2020