UK shares post-Brexit device guidance as uncertainty around EU split looms

MHRA this week outlined which medtech manufacturers will need to register and when. The timeline is determined by the previously disclosed grace period which ends Jan. 1, 2021.

By Nick Paul Taylor • Dec. 11, 2020

FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval

A panel of independent experts agreed the benefits of vaccination outweigh the risk, convinced by strong data showing the companies' shot to be 95% effective in preventing COVID-19.

By Ned Pagliarulo • Updated Dec. 10, 2020

Explore the Trendline➔

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

LabCorp gets EUA for first at-home collection COVID-19 test with no prescription

The lab giant is selling the kit through its consumer-focused Pixel website and may expand into retail channels. The agency is hoping the over-the-counter diagnostic will spur more testing.

By Nick Paul Taylor • Dec. 10, 2020

Roche, Thermo Fisher ally with COVID-19 vaccine developers on antibody testing

The companies are working with Moderna and the University of Oxford to quantitatively measure the antibody levels of recipients of the shots.

By Nick Paul Taylor • Dec. 10, 2020

Regulatory Disruption of the Year: HHS lab developed test policy

The surprise move to no longer require FDA premarket review for laboratory developed tests spurred backlash across a spectrum of public health experts and industry.

By Greg Slabodkin • Dec. 9, 2020

The MedTech Dive Awards for 2020

From the relentless demand for COVID-19 tests to the pressure on medtechs' traditional business lines, the industry has faced unprecedented market forces this year.

By MedTech Dive Team • Dec. 9, 2020

Hospitals prepare to reveal prices online come Jan. 1

The rule requires hospitals to prepare a list of pricing information for 300 "shoppable services," such as total knee replacements. However, experts question if the data will benefit consumers.

By Samantha Liss • Dec. 8, 2020

ACA defender Becerra tapped for Biden's HHS chief

The California attorney general has voiced opposition to provider consolidation in his state, alleging anticompetitive practices by regional powerhouse Sutter Health and denying a hospital system merger.

By Shannon Muchmore • Dec. 7, 2020

Endologix AAA graft to go before FDA panel over potential life-threatening leak risk

The agency also released postmarketing data reinforcing an increased likelihood of blood leaking into the aneurysm for patients with the company's AFX endovascular grafts.

By Susan Kelly • Dec. 7, 2020

Quest gets first FDA nod for at-home collection coronavirus-flu combo test

The lab giant is using Roche’s diagnostic and instrument, which received an emergency use authorization in September, with its own process for testing samples collected by consumers.

By Nick Paul Taylor • Dec. 7, 2020

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

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