FDA OKs device to avert traumatic brain injury during sports

Approval was based in part on a study of 284 U.S. high school football players, suggesting the neck-worn product can minimize "slosh" in the brain that occurs in unprotected athletes who suffer head impacts.

By Nick Paul Taylor • March 1, 2021

J&J's single-dose coronavirus vaccine becomes third authorized in US

A CDC vaccine panel recommended use of the shot on Sunday following FDA authorization, and McKesson began shipping out doses to states Monday.

By Ned Pagliarulo • Updated March 1, 2021

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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

iRhythm still faces reimbursement uncertainty after meetings with Medicare rate negotiator

CEO Michael Coyle said the cardiac monitoring company and other industry representatives met with a Medicare Administrative Contractor twice, but added that there are no assurances rates will come up.

By Ricky Zipp • Feb. 26, 2021

Becerra backs price transparency, provider competition at first Senate panel

President Joe Biden's pick for HHS chief turns Wednesday to the finance panel, which will vote on sending the nomination to the full Senate.

By Shannon Muchmore • Feb. 24, 2021

ACLA urges Biden to fund uninsured COVID-19 testing, close coverage loopholes

The plea from the trade group for Quest and LabCorp is the latest in a row between labs and insurers over paying for the diagnostics and comes as a $2 billion federal testing fund runs dry.

By Nick Paul Taylor • Feb. 24, 2021

UK adopts medical device legislation, setting stage for new databases and sanctions

Politicians framed the new law as furthering efforts to fix failings that delayed regulatory responses to safety problems with products including pelvic mesh.

By Nick Paul Taylor • Feb. 24, 2021

FDA lays path to weigh virus variant impact on COVID-19 test results

The agency wants diagnostic companies to factor the potential for variants to evade detection into their test development and monitoring, Center for Devices and Radiological Health chief Jeff Shuren said.

By Nick Paul Taylor • Feb. 23, 2021

FDA starts review of how skin pigmentation affects pulse oximeter results

The agency is evaluating published literature related to factors that may affect device accuracy and performance, following pressure from senators to address concerns that "racism may be embedded in key clinical tools."

By Nick Paul Taylor • Feb. 22, 2021

Boston Scientific's ICD recall gets 2nd Class I label from FDA

A new agency notice covers a fault that allows moisture to enter the medical device, causing it to short circuit when it tries to shock the patient. Boston Scientific has not received reports of injuries or deaths linked to the problem.

By Nick Paul Taylor • Feb. 22, 2021

Why this week's FDA meeting on J&J's coronavirus vaccine will be important

The agency is widely expected to OK the one-dose shot, but the advisory panel will offer a window into debate over several key issues, including related to the new virus variants. 

By Ben Fidler , Ned Pagliarulo • Feb. 22, 2021

Obama admin alum Chiquita Brooks-LaSure tapped to head CMS

AdvaMed backed the nomination, noting a new Medicare rule that gives developers of FDA-designated breakthrough devices the potential to sell them and be reimbursed on the day of market approval.

By Shannon Muchmore • Feb. 18, 2021

BD drug-coated balloon falls short at FDA panel, signaling likely rejection

While the advisory committee largely agreed that Lutonix was safe, the majority did not believe it was effective nor that the benefits outweighed the risks.

By Ricky Zipp • Feb. 18, 2021

FDA approves 3D-printed ankle implant for humanitarian use

Additive Orthopaedics makes the devices from cobalt chromium alloy to treat avascular necrosis, a rare bone disease. It is the first patient-specific total talus replacement implant approved by the agency.

By Nick Paul Taylor • Feb. 18, 2021

COVID-19 EUAs drive FDA to record 2020 novel device OKs

The tally tops the 106 novel device authorizations in 2018 that marked a 40-year high. 

By Susan Kelly • Feb. 17, 2021

One-third of US adults postponed care during pandemic: reports

Among those surveyed, 25% put off dental care, while 21% put off checkups and 16% put off screenings or medical tests, researchers from the Urban Institute and RWJF found.

By Ron Shinkman • Feb. 16, 2021

BD drug-coated balloon faces uphill battle in FDA panel review

Advisers on Wednesday are weighing the PAD treatment, but the agency has said data limitations make it hard to draw conclusions about safety and effectiveness. Evercore ISI analysts predict a negative vote.

By Susan Kelly • Updated Feb. 17, 2021

FDA admits COVID-19 antibody test policy was 'flawed,' offers lessons for future outbreaks

Writing in the New England Journal of Medicine, agency officials acknowledged "touting the potential usefulness" of serology tests early in the pandemic contributed to flooding the market with poorly performing diagnostics.

By Nick Paul Taylor • Feb. 16, 2021

In run-up to MDR, EU posts guide to legacy devices in Eudamed

The guidance explains when manufacturers need to register on the new database and walks through details such as how to link products covered by the outgoing and new regulatory frameworks.

By Nick Paul Taylor • Feb. 15, 2021

Visby gets FDA nod for single-use, rapid point-of-care COVID-19 PCR test

The palm-sized diagnostic gives results in 30 minutes without the need for additional instruments or readers. While Abbott's ID Now provides results in 13 minutes or less, it is the size of a toaster and requires a cartridge. 

By Greg Slabodkin • Feb. 10, 2021

Heart disease devices lead latest batch of FDA breakthrough nods

The cardiovascular-focused products are part of a wider group of designations including those in development at companies such as Roche. 

By Nick Paul Taylor • Feb. 10, 2021

Medicare DME competitive bidding in doubt after failed round: analysts

Cowen analysts said a recent report found steep rate hikes, leading them to conclude the program is no longer such a big threat to companies like Baxter, ResMed and Philips.

By Nick Paul Taylor • Feb. 8, 2021

FDA OKs Signifier neurostim device for snoring, sleep apnea

Signifier now faces the challenge of establishing eXciteOSA in the congested snoring and sleep apnea market targeted by companies including ResMed.

By Nick Paul Taylor • Feb. 8, 2021

FDA appoints first medical device cybersecurity chief

University of Michigan professor Kevin Fu will serve a one-year term as acting cyber director at the Center for Devices and Radiological Health. Experts fear the chaos of the pandemic creates the perfect storm for hackers to exploit.

By Greg Slabodkin • Feb. 3, 2021

Death, injuries prompt FDA to call Boston Scientific ICD recall Class I event

The device giant began recalling the subcutaneous implantable defibrillator system electrode late last year after learning of 26 serious injuries and one death associated with the device.

By Nick Paul Taylor • Feb. 3, 2021

DoD awards Ellume $231M to increase US production of at-home, OTC COVID-19 test

The Australian diagnostics company will use the funding to establish a U.S. manufacturing facility that is projected to increase production capacity by 640,000 tests per day by December.

By Susan Kelly • Feb. 2, 2021