Siemens COVID-19 test gets high marks on FDA sensitivity list, beating Abbott, BD and Roche

A PerkinElmer test still holds the top position among coronavirus diagnostics least likely to return false negatives.

By Nick Paul Taylor • Dec. 4, 2020

CDRH headed for 'reset' in 2021 after COVID-19 derailed priorities, Shuren says

After a "massive increase" in work due to the pandemic, the device center anticipates continuing to manage coronavirus projects while also focusing on MDUFA V and new programs.

By Ricky Zipp • Dec. 3, 2020

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

CMS adds hip replacements, other surgeries to ASC list in final rule

A representative from Stryker applauded the changes and said the rule will encourage providers to consider the shift to ambulatory surgery centers.

By Ricky Zipp • Updated Dec. 4, 2020

EU underscores remote notified body audit policy amid pandemic

MedTech Europe has pressed the Commission to expand such reviews to the incoming MDR and IVDR regs, but a new Q&A notes the scope is limited to the directives and devices considered "clinically necessary" during the crisis.

By Nick Paul Taylor • Dec. 3, 2020

CMS finalizes expanded artificial heart, ventricular assist device coverage

Medicare will cover artificial hearts outside of clinical studies and align VAD coverage criteria with medical practice. Cowen called the decision good for Abbott and Medtronic.  

By Nick Paul Taylor • Dec. 2, 2020

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 • 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

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 • 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