Company of the Year: Abbott

Demand for the diversified medtech's array of coronavirus tests puts it on solid financial ground going into 2021, amid a challenging year for the medical device industry.

By Maria Rachal • 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

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

Bayer updates Essure birth control device reports of deaths, injuries on social media

The company underscored FDA’s acknowledgement of the challenges of drawing conclusions from social media posts, which come with potential for biased and inaccurate information.

By Susan Kelly • Updated Dec. 8, 2020

Boston Scientific's Lotus ditch creates 'duopoly' in growing TAVR market

Edwards Lifesciences and Medtronic are now the primary rivals in the transcatheter aortic valve replacement market, which analysts expect to rapidly grow in coming years.

By Ricky Zipp • Dec. 8, 2020

GE medical imaging devices impacted by critical cyber vulnerability

Dozens of products like CT scanners and MRI machines are susceptible to hackers getting access to sensitive health data and disrupting their operation, according to firm CyberMDX. GE says there is no risk to patient safety.

By Greg Slabodkin • Dec. 8, 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

Olympus to pay $300M to buy Veran for lung navigation system

The deal is for $300 million up front, with another $40 million tied to an undisclosed milestone.

By Nick Paul Taylor • Dec. 7, 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

LivaNova offloads heart valve tech to Gyrus Capital following investor pressure

The announcement comes shortly after activist shareholder PrimeStone Capital demanded LivaNova sell or close the "likely loss-making" business line.

By Maria Rachal • 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

Medtechs, working with FDA, offer guidance for remote control of medical devices during pandemic

GE Healthcare, Medtronic, Philips and ResMed are among those that have modified products with such capabilities to create safe physical distance between providers and COVID-19 patients.

By Greg Slabodkin • 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

Zimmer puts up $250M in surgical device deal, Boston Scientific nets $800M in BTG pharma sell-off

The pandemic hasn't stopped M&A in the medtech industry, with Zimmer Biomet adding to its sternal closure device lineup via A&E Medical and Boston Scientific streamlining business with a sale to specialty pharma group SERB.

By Nick Paul Taylor • 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

Nevro Q4 sales to drop as COVID-19 headwinds stiffen: analysts

If the change in tone reflects growing unwillingness of patients to get elective care as cases surge, as Baird analysts believe, the update could have implications for other medical device companies.

By Nick Paul Taylor • Dec. 1, 2020

Hospitals adopt new round of elective surgery restrictions, brace for Thanksgiving COVID-19 surge

The American College of Surgeons is among those placing new emphasis on factoring healthcare worker wellbeing into capacity decisions.

By Maria Rachal • Nov. 25, 2020

Medtronic ends earnings season with mixed results vs. TAVR rival Edwards

The medtech giant's financials reported Tuesday, with a month more of COVID-19 trends factored in compared to competitors, also show some divergence in the spine and neuromodulation markets.

By Nick Paul Taylor • Nov. 25, 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

Medtronic details diabetes, TAVR offensives as COVID-19 recovery progresses

Q2 data shows how Medtronic's turnabout has been faster than expected, but the company declined to give future guidance because of the global coronavirus resurgence, CEO Geoff Martha said.

By Greg Slabodkin • 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

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

Abbott on track to top Q4 CGM sales estimates, rise in US FreeStyle Libre scripts suggests

UBS analysts predict the franchise will grow around 40% in the quarter, well above estimates, based on an increase in prescriptions for the new integrated continuous glucose monitor.

By Nick Paul Taylor • Nov. 23, 2020