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

Edwards plots TAVR comeback even as COVID-19 surge hits harder

"We've seen a fall-off and we felt it globally, but it's probably more predominant in the U.S.," CEO Michael Mussallem said of the impact of some hospitals limiting elective surgeries.

By Ricky Zipp • Dec. 10, 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

Dexcom lays out strategy to double revenue by 2025, eyes hospitals, new markets

Wall Street analysts called the five-year guidance by the maker of continuous glucose monitors conservative, but investors were not so sure, sending shares down more than 4% on Wednesday.

By Ricky Zipp • Dec. 9, 2020

Registry finds no link between paclitaxel-coated devices and mortality risk: NEJM

The data add to evidence accumulating since a 2018 meta-analysis led the FDA to hold an advisory meeting and add new label warnings, putting pressure on medtechs like Boston Scientific and Medtronic. 

By Nick Paul Taylor • Dec. 9, 2020

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

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 Parduhn • 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