Medical Devices: Page 115
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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 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew 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 -
Alex Wong via Getty Images
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 -
Courtesy of Abbott
Dive Awards
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 -
Brian Tucker/MedTech Dive
Dive Awards
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 -
Deep Dive
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 -
Courtesy of LivaNova/Businesswire
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 -
Courtesy of Abbott
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 -
Alex Wong via Getty Images
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 -
Permission granted by iRhythm Technologies
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
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