Breakthrough designations go to renal denervation devices in latest FDA batch

ReCor and SoniVie disclosed the regulatory privileges within a day of each other, boosting their efforts to enter a market targeted by Medtronic.

By Nick Paul Taylor • Dec. 16, 2020

Boston Scientific, Nevro agree to nix 1 patent lawsuit, but other legal fights go on

While the parties agreed to dismiss Nevro's case involving high-frequency spinal cord stimulation therapy against the medtech giant, separate disputes are active over related technology.

By Greg Slabodkin • Dec. 15, 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

FDA lays out alternative 510(k) path criteria for 3 device types

The agency finalized guidance documents covering several product categories — spinal plating systems, orthopaedic bone screws and magnetic resonance coils — as it pushes forward with its Safety and Performance Based Pathway.

By Susan Kelly • Dec. 15, 2020

Medtronic's Coyle to replace iRhythm CEO King in switch-up

The leadership change comes after a series of ups and downs for iRhythm, but the cardiac digital health company is still performing better than expectations. Wall Street analysts were mixed on the impact.

By Ricky Zipp • Dec. 15, 2020

MDR-IVDR bottleneck persists as EU launches 1st Eudamed module

"Very few notified bodies at this moment in time are taking new products on under the old directive, because a medical device doesn't just get certified overnight," an official at Ireland's National Standards Authority said.

By Nicholas Wallace • Dec. 14, 2020

BD calls for 'Zero Trust' to combat rising healthcare hacking amid pandemic

The medtech warns threats are plaguing the industry as providers increasingly rely on telehealth and remote monitoring to deliver care to patients.

By Susan Kelly • Dec. 14, 2020

Trump admin defends national stockpile as PPE, equipment shortages persist

"We’re not the Walmart that you can walk into on a daily basis to get your standard needs to treat patients and get PPE. We are a 911 response team," an HHS official said, adding the stockpile hasn't denied a single state request.

By Rebecca Pifer • Dec. 14, 2020

Trump admin proposes easing HIPAA to foster value-based care, COVID-19 contact tracing

One goal in revamping the privacy regulations was to make information sharing more efficient, especially during health crises like the opioid epidemic and the coronavirus outbreak, according to top health officials. 

By Rebecca Pifer • Dec. 11, 2020

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

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 • Dec. 2, 2020