CMS makes some telehealth coverage permanent, finalizes specialty rate cuts

Areas getting pay slashed include thoracic and cardiac surgery and interventional radiology, Credit Suisse analysts said. Surgeon groups decried the changes.

By Rebecca Pifer Parduhn • Dec. 2, 2020

Digital therapeutic De Novos climb with FDA nod to IBS treatment

Despite a series of first-of-their-kind authorizations for such tech, total 2020 De Novo OKs currently match a 2019 low in recent years.

By Maria Rachal • Dec. 1, 2020

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

iRhythm gains UK support for EKG system while awaiting key final rule from CMS

The ambulatory cardiac monitoring system is one of just six medtech products recommended this year in guidance from the U.K. National Institute for Health and Care Excellence. The focus is on individuals with suspected arrhythmias.

By Maria Rachal • Dec. 1, 2020

CMS expands ability for hospital-level care at home ahead of holiday virus spread

Six health systems received waivers to treat more than 60 acute conditions under the new program, which also tweaks earlier changes allowing ambulatory surgical centers to provide greater inpatient care. 

By Shannon Muchmore • Nov. 30, 2020

IVDR notified body count inches up to 5 with TÜV Rheinland designation

The medtech notified bodies trade group urged swift action on potentially delaying the start date for the In Vitro Diagnostic Regulation if designations don't more than double by year's end.

By Nick Paul Taylor • Updated Nov. 30, 2020

Breast cancer tech among FDA's latest breakthrough nods

Over the past month, designations for speedier review have also ranged from a migraine treatment to tissue regeneration tech for spinal cord injuries.

By Susan Kelly • Nov. 24, 2020

Medical device makers get more flexibility with value-based care in Stark, anti-kickback final rules

The changes include two safe harbor pathways and "allow you to do things that otherwise might violate the kickback statute or the Stark Law. So, that is always welcome in the industry," one lawyer said.

By Ricky Zipp • Nov. 24, 2020

In last-minute push, Trump admin rolls back Stark, anti-kickback rules

The final regs are slated to take effect Jan. 19, one day before President-elect Joe Biden is inaugurated. The new administration could change them but experts called that unlikely.

By Rebecca Pifer Parduhn • Nov. 23, 2020

NEJM commentary calls for 510(k)s for OTC hearing aids after senators pan FDA delay to rule

While critics of the delay acknowledged FDA's coronavirus-related workload this year, the agency has failed to come through with the draft regulation required by a 2017 law.

By Nick Paul Taylor • Nov. 23, 2020

MedTech Europe backs proposed EU Health Union but flags potential hangups

The trade group fears moving responsibility for administering the IVDR and MDR expert panels to the European Medicines Agency could slow deployment.

By Nick Paul Taylor • Nov. 20, 2020

Notified bodies report early success with remote audits but challenges remain

While there have been benefits to going remote during the pandemic, 57% of those polled by a European trade group say they take longer than on-site assessments and most encounter problems due to poor network connections.

By Nick Paul Taylor • Nov. 20, 2020

HHS piloting Cue's NBA-tested rapid COVID-19 diagnostic in 5 states

Unlike lab-based molecular tests, which can take two to three days to turn around, Cue Health's point-of-care molecular test generates results in about 20 minutes.

By Maria Rachal • Nov. 19, 2020

Health insurers, labs point fingers over COVID-19 test coverage and prices

An AHIP study of claims data is the latest volley in a debate about who ultimately foots the bill for coronavirus diagnostics. ACLA blames "murky" tri-agency guidance for coverage denials and high out-of-pocket costs. 

By Nick Paul Taylor , Greg Slabodkin • Nov. 19, 2020

FDA OKs first fully at-home COVID-19 test as US cases surge

An emergency use authorization to biotech Lucira Health comes as some experts say the tests could help significantly boost capacity. Others say that's a long way off, and call for more guidance from regulators on proper use.

By Greg Slabodkin • Nov. 18, 2020

In shift, FDA ordered to provide 'timely' EUA reviews for COVID-19 lab developed tests

Testing czar Brett Giroir has reversed FDA's decision to no longer review emergency use authorization requests for LDTs so that university labs can secure EUAs and get liability protection under the PREP Act.

By Greg Slabodkin • Nov. 17, 2020

FDA draft guidance expands electromagnetic compatibility advice for medtechs

A new document builds on a very brief final guidance from 2016, as the agency looks to gather the right information on how devices function in intended electromagnetic environments.

By Nick Paul Taylor • Nov. 17, 2020

EU regulators provide 7 rules for classifying diagnostics under IVDR

The European Commission's Medical Device Coordination Group placed IVDs into different risk categories based on how they will be used. Only one class can be self-certified.

By Nick Paul Taylor • Nov. 16, 2020

Labs face COVID-19 surges, warn of test result delays as CMS pay cuts loom

The American Clinical Laboratory Association sounded an alarm over nationwide capacity constraints, which may increase average time to results.

By Maria Rachal • Nov. 13, 2020

BD's Alaris infusion pumps flagged for cybersecurity vulnerability

The Department of Homeland Security alert scored the issue 6.5 out of 10 and said a successful attack that exploited the weakness could force operators to manually program the pumps.

By Nick Paul Taylor • Nov. 13, 2020

3 ways Biden's COVID-19 approach could impact medtech

A new administration — regardless of who's in power — means device makers can anticipate shifts at key government agencies like the FDA.

By Maria Rachal , Greg Slabodkin • Nov. 12, 2020

Qiagen seeks EUA for COVID-19 antigen test aiming for positive results in 2 minutes

The company claims 90% sensitivity, whereas other antigen tests sold by Abbott, Roche and Quidel have reported sensitivities of around 97%.

By Nick Paul Taylor • Nov. 12, 2020

Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills

The Senate appropriations committee released a series of budget proposals for fiscal 2021. FDA's device center is slated for a 5% funding increase, making it one of the only centers set to receive less than requested.

By Nick Paul Taylor • Nov. 11, 2020

UK fleshes out post-Brexit approach to regional medical device marking

The Medicines and Healthcare products Regulatory Agency further clarified conformity marking as medtechs prepare for the transition period to end.

By Nick Paul Taylor • Nov. 11, 2020

Top picks for who could run HHS, CMS under Biden

Former Obama adviser and ACA architect Ezekiel Emanuel as well as high-profile state officials like New Mexico Governor Michelle Lujan Grisham are among those considered likely advisers.

By Rebecca Pifer Parduhn • Nov. 10, 2020

Abbott COVID-19 tests at center of squabble between Trump administration, states

HHS testing czar Brett Giroir on Monday said the government is halting the antigen test shipments to eight states until those already sent are distributed and used. At least one state pushed back on his assertions.

By Greg Slabodkin • Nov. 10, 2020