Policy & Regulation
-
Retrieved from C-SPAN on February 23, 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 -
Retrieved from The White House/YouTube on January 21, 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 -
Explore the Trendline➔
Kendall Davis/MedTech Dive, original photos courtesy of Abbott and Dexcom
TrendlineThe MedTech Dive Outlook on 2021
The pandemic will keep disrupting the industry in the year ahead, as COVID-19 testing wanes and elective procedures slowly ease back. We look at the risks, challenges and opportunities.
By MedTech Dive staff -
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 -
Jacob Bell / BioPharma Dive
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 -
Jacob Bell
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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 -
Retrieved from Manatt on February 18, 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 -
Jacob Bell
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 -
Brian Tucker
COVID-19 EUAs drive FDA to record 2020 novel device OKs
The tally tops the 106 novel device authorizations in 2017 that marked a 40-year high.
By Susan Kelly • Feb. 17, 2021 -
Fotolia
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 -
Jacob Bell / BioPharma Dive
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 at 9:45 a.m. -
Getty Images
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 -
Jacob Bell
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 -
Jacob Bell / BioPharma Dive
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. 08, 2021 -
Jacob Bell
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. 08, 2021 -
Jacob Bell / BioPharma Dive
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. 03, 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. 03, 2021 -
Courtesy of Ellume Health
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. 02, 2021 -
Brian Tucker Industry Dive Image | courtesy of California Office of Attorney General
How might Xavier Becerra operate as HHS Secretary?
The nominee has made headlines since leaving the House of Representatives, in part by leading blue state efforts to defend the ACA. Less high-profile, perhaps, were his efforts to block major hospital mergers in California.
By Ron Shinkman • Feb. 01, 2021 -
Fotolia
Deep Dive3 big predictions for digital health in 2021
As tech and data sharing become more pervasive, healthcare will likely pivot to being more predictive and telehealth will evolve, giving rise to new modalities of care. This will force companies to invest more in cybersecurity.
By Rebecca Pifer • Jan. 29, 2021 -
Low Medicare EKG device draft slams iRhythm, stock price sinks by over 30%
Wall Street analysts questioned whether the lower-than-expected rates are final and what the prospects are for renegotiation. Shares of market leader iRhythm fell over 32% on Friday.
By Ricky Zipp • UPDATED: Feb. 1, 2021 at 10:28 a.m.
