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 3, 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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

Hospitals push FEMA to form broad supply pact with medtech

The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.

By Nick Paul Taylor • Updated May 26, 2020

COVID-19 drives EC to change rules on notified body designations

The European Commission is allowing certain deviations from normal procedures governing notified bodies, enabling renewal of designations under the outgoing device regulations without performing on-site assessments.

By Nick Paul Taylor • May 20, 2020

Labs welcome CMS rate for coronavirus antibody testing

Analysts at William Blair said the roughly $42 rate for common serological tests is higher than expected, which may bode well for antigen testing reimbursement.

By Nick Paul Taylor • May 20, 2020

FDA OKs 1st at-home collection kit for use with multiple labs, coronavirus tests

The emergency use authorization to Everlywell follows earlier nods to LabCorp and Rutgers Clinical Genomics Laboratory for at-home specimen collection for analysis solely at their own labs.

By Nick Paul Taylor • May 18, 2020

Allergan's breast implant postmarket studies 'unacceptable,' FDA warns

Within the last 14 months, every manufacturer of the controversial devices allowed for sale in the U.S. has received a warning letter from the agency.

By Maria Rachal • May 15, 2020

FDA revokes umbrella EUA for infusion pumps due to lack of industry use

The agency told medtechs it may instead grant individual EUAs for the devices going forward. B. Braun contends it is the only company with such an emergency authorization and is not affected by the revocation.   

By Greg Slabodkin • Updated Sept. 24, 2020

Cardiology group ranks best devices for aorto-iliac arterial interventions

The Society for Cardiovascular Angiography and Interventions detailed stances on several key issues, including endovascular device effectiveness, issued Thursday at its virtual conference.

By Nick Paul Taylor • May 15, 2020

Philips, startups look to deploy new ultrasound tech amid coronavirus

The need for point-of-care imaging for lung and cardiac complications among COVID-19 patients has led to a flurry of expedited FDA reviews.

By Nick Paul Taylor • May 14, 2020

EC outlines clinical trial safety reporting between MDR, Eudamed start dates

Even with the recent delay to the date of application of the Medical Device Regulation, there will still be at least a 12-month period when the key Eudamed database is not fully available.

By Nick Paul Taylor • May 14, 2020

House Dems carve out $75B for coronavirus testing, contact tracing in bid for new relief package

The $3 trillion bill passed the House by a vote of 208-199 on Friday. It's Democrats' opening gambit for the next wave of congressional action, but Republicans say they're not in a hurry to approve new funding.

By Susan Kelly • Updated May 18, 2020

FDA flags 2nd high-risk recall of embolectomy catheters in recent weeks

The potential for a detached catheter tip to damage blood vessels and cause serious injuries or death underpinned the agency’s Class I label for an Applied Medical recall on Tuesday, seven months after the company initiated the recall.

By Nick Paul Taylor • May 13, 2020

Eko algorithm gets FDA nod for cardiac screening of COVID-19 patients

Developed with the Mayo Clinic, Eko's algorithm gained breakthrough device status in December and review was further accelerated given its potential to identify patients at higher risk of poor outcomes with the coronavirus.

By Nick Paul Taylor • May 13, 2020

As Trump pushes states to reopen, Fauci warns against lifting COVID-19 restrictions too soon

The U.S. doesn't have the necessary testing and surveillance infrastructure in place to prep for a fall resurgence of the coronavirus, a second wave that's "entirely conceivable and possible," Fauci told a Senate panel.

By Rebecca Pifer • May 12, 2020

Abiomed faces familiar reimbursement fluctuation in CMS proposal

An almost 25% reduction to a key heart implant procedure payment code, plus backing for three breakthrough-designated devices, are among the policies outlined in a Medicare proposed rule released Monday afternoon.

By Maria Rachal • May 12, 2020

LabCorp at-home collection test kit for coronavirus goes mainstream, as states get $11B for testing efforts

The tests, originally only offered to frontline workers, are now available even to individuals without symptoms who may have been exposed to the virus. Still, clinical labs say more support is needed to further ramp up capacity.

By Greg Slabodkin • May 12, 2020

FDA, CDC drawing up plan to restart routine facility inspections

A phased approach is in the works to reintroduce certain oversight that's been on hold both domestically and internationally since the coronavirus outbreak reached pandemic level in March.

By Nick Paul Taylor • May 12, 2020