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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.

Medtronic offers 10-year data, pivotal trial update on transcatheter pulmonary valves

A decade of data on the Melody valve found it more effective in adults than in pediatric patients. In a separate study, the in-development Harmony valve designed to treat severe pulmonary regurgitation met its primary endpoints.

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.

UnitedHealth, Microsoft launch COVID-19 screening app for employers

The healthcare behemoth said it will control employees' medical data and manage opt-in and consent requirements for users. The app will not provide tracking or contact tracing information.

FDA aims to thwart infusion pump shortage with new industrywide emergency use authorization

The agency is responding to insufficient availability of the lifesaving machines and accessories for COVID-19 patients. 

Abbott on defense as FDA flags false negative reports with point-of-care coronavirus test

An independent study circulated this week showed the rapid ID Now COVID-19 test could miss 48% of positive cases under some conditions. Abbott said late Thursday a backup test should be performed in certain cases.

Consumer COVID-19 fears, coverage concerns could stymie medtech rebound: Wall Street surveys

Some analysts say industry predictions on timing of a rebound in elective procedures may be too rosy.

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.

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.

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.

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.

Q&A

Are CFOs ready to go with the EU Medical Device Regulation?

Requiring fewer applications to submit for approval, the new process could ultimately cost companies less, according to a CFO Dive interview with the director of market access for life sciences at BDO USA.

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.

UPDATED: May 18, 2020 at 10:38 a.m.

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.

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.

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.

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.

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.

Wright Medical sales miss consensus as lower extremities business drags

Additionally, the device maker set to be acquired by Stryker has amended a credit agreement with lenders, which some analysts expect to dampen any concern that the buyer could look to renegotiate the deal.

Latest Abbott coronavirus antibody test receives FDA emergency use OK

The EUA is the company's second for a test detecting the IgG antibody, using a different machine than the first. Across both, it plans to ship almost 30 million units worldwide in May and double that amount in June. 

Zimmer posts $509M loss in Q1 as 80% of business faces COVID-19 hit

Like rivals, the medtech expects Q2 to bear the brunt of deferred procedures. But the pace of expected recovery thereafter is fluid and does not assume significant recurrence of the virus later this year, execs noted.

1st antigen test to detect coronavirus gets FDA nod

The agency, which gave the green light on Saturday to Quidel, expects the tests to be cheaper to make than PCR tests.

FDA authorizes 1st coronavirus test using at-home collection of saliva samples

The update to an EUA given last month for a test developed at Rutgers allows for at-home collection of specimens for the saliva-based test, although scope of the offering remains somewhat limited for now.

UPDATED: May 11, 2020 at 12:40 p.m.

AtriCure treatment for persistent AFib shows superiority in study

The ablation procedure met study goals among patients with hard-to-treat forms of the heart rhythm disorder, which analysts say put it on track for FDA approval to address a market worth at least $1 billion.

BD says surgery revenues fell as much as 70% in April

As it faces pandemic headwinds, BD is also continuing to deal with problems with its Alaris infusion pump system and modules and expects to record a $200 million charge related to remediation efforts.