Intersect touts CMS coverage changes as boon for patient, physician access

The agency published an average selling price for Intersect's corticosteroid-eluting sinus implant treatment for nasal polyps, which "should help clarify payment and ease payor coverage adjudication," SVB Leerink analysts wrote.

By Nick Paul Taylor • March 9, 2021

Abbott capitalizes on digital health boom with virtual clinic for neuromodulation therapy

The FDA-approved virtual clinic is the medtech giant's next step to gain share in the neurmod market from rivals Medtronic, Boston Scientific and Nevro.

By Nick Paul Taylor • March 9, 2021

Coronavirus relief bill with rural hospital aid, over $47B for testing passes Senate

The nearly $2 trillion bill includes $47.8 billion to boost COVID-19 testing and contact tracing efforts, including supporting the development, manufacturing and administering of tests.

By Shannon Muchmore • March 8, 2021

FDA grants first EUA to at-home OTC molecular test for COVID-19

Cue Health received the emergency authorization and expects to be able to produce more than 100,000 tests a day by the summer, as the agency continues to prioritize more at-home testing options.

By Nick Paul Taylor • March 8, 2021

Insulin pump adoption seen climbing 21% in 2021 on wearables boom: survey

The SVB Leerink poll of 101 endocrinologists and nurse practitioners also projects a shift in market position among top players like Medtronic, Insulet and Tandem Diabetes Care.

By Ricky Zipp • March 5, 2021

Warchests, distressed assets drive medtech M&A flurry early in 2021

The industry is averaging more than one $100 million-plus takeover a week, as the influx of COVID-19 test revenues and pressures on companies reliant on surgical procedures create buying opportunities.

By Nick Paul Taylor • March 5, 2021

Becerra's HHS secretary bid moves forward on tie committee vote

White House press secretary Jen Psaki said Wednesday the president remained "confidently behind the nomination" despite the close committee vote.

By Shannon Muchmore • Updated March 4, 2021

FDA lays out data modernization action plan

"Even small advances in our ability to gain useful insights from data can represent significant opportunities," Janet Woodcock and Amy Abernethy, respectively FDA's acting commissioner and acting CIO, wrote.

By Nick Paul Taylor • March 4, 2021

FDA clamps down on bogus device 'registration certificates' amid rising use during pandemic

The agency sent letters to 25 companies after identifying a boost in use of materials "deceptively indicating" it had assessed medical devices.

By Nick Paul Taylor • March 4, 2021

Boston Scientific puts up $1B in cash to buy Lumenis surgical line from private equity

Wall Street analysts generally applauded the deal, which will see the medtech leader acquiring a portfolio of laser systems with potential to reach fast-growing markets like China.  

By Ricky Zipp • Updated March 4, 2021

Quidel, Eurofins get EUAs as at-home COVID-19 test market heats up

The companies join Abbott, Ellume and Lucira with FDA-authorized offerings. A Craig-Hallum analyst called the emergency use authorization "the first step in morphing at-home testing into a multi-billion-dollar market."

By Nick Paul Taylor • March 2, 2021

CMS moves to stop COVID-19 testing denials, cost sharing in private plans

The trade group for Quest and LabCorp praised what it called "decisive action" by the Biden administration to close coverage gaps that have denied people access to tests.

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

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

NuVasive buys Simplify Medical in play for $2.6B cervical spine market

The $150 million acquisition will add to the pandemic-related challenges for NuVasive in 2021, with investments to train surgeons and run clinical trials offsetting the low anticipated sales this year.

By Nick Paul Taylor • Feb. 26, 2021

Axonics adds incontinence device to portfolio in $200M Contura takeover

The targeted prescribers of Contura's urethral bulking agent are the same physicians who use Axonics' implantable sacral neuromodulation to treat urinary disorders. Analysts said the business logic seems sound.

By Nick Paul Taylor • Feb. 26, 2021

UK industry pushes for pre- and post-vaccination roles for COVID-19 antibody tests

The bid by Abingdon Health, CIGA Healthcare and Omega Diagnostics comes as Quest introduced a test to measure antibodies in the previously infected. Still, CDC does not recommend such testing to assess the need for vaccines.

By Nick Paul Taylor • Feb. 25, 2021

Diabetes wearables look resilient through 2021, bucking broad medtech trends

Dexcom, Tandem and Insulet pointed to targeting Type 2 patients and DTC as growth drivers in posting year-end results. One analyst gushed that "the golden age of diabetes care is still here."

By Ricky Zipp • Feb. 25, 2021

Nevro predicts resurgent pain implant sales in 2021 after slow start to the year

William Blair analysts said market growth is likely to remain challenging in the short run as CEO Keith Grossman argued the company was not losing share to rivals, which include Medtronic and Abbott.

By Nick Paul Taylor • Feb. 25, 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

Outpatient visits steady at end of 2020 but orthopaedics, cardiology remain down: report

Visit declines in specialty categories highlighted by the Commonwealth Fund report were in line with procedure trends top medtechs outlined during fourth-quarter earnings calls.

By Samantha Liss • Feb. 23, 2021

Medtronic sees capital equipment uptick despite latest coronavirus surge

Still, CFO Karen Parkhill observed that in February the company has "not yet seen a turnaround" as a result of severe winter weather in the U.S.

By Greg Slabodkin • Feb. 23, 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