Medical Devices: Page 108
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Danielle Ternes/MedTech Dive
Q&ADexcom CEO on the Type 2 population, the Super Bowl ad and pandemic momentum
Kevin Sayer called Type 2 a "tremendous market opportunity" and said direct-to-consumer advertising is worth some controversy.
By Ricky Zipp • July 6, 2021 -
Sarah Silbiger via Getty Images
Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods
Neuroelectrics, Neuros Medical and Onward are among those that secured the regulatory privilege, which speeds the review process for unmet medical needs.
By Nick Paul Taylor • July 2, 2021 -
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
Biden admin unveils new ESRD payment model in health equity push
Tweaks to the end-stage renal disease model alter scoring methodology to incentivize dialysis providers to lower disparities in home dialysis and kidney transplant rates among patients from disadvantaged communities.
By Rebecca Pifer • July 2, 2021 -
Getty Images
PMA apps could hit record in 2021, pressuring a pandemic-stressed FDA
Despite increased workloads from the coronavirus crisis, the agency is also on track to issue record numbers of safety warnings and letters to healthcare providers in 2021, according to a Wells Fargo analysis.
By Nick Paul Taylor • July 2, 2021 -
Stefani Reynolds/Stringer via Getty Images
Supreme Court redefines limits on patent attacks by inventors in Hologic decision
The High Court upheld the doctrine that stops inventors challenging their own patents but placed limits on its use.
By Nick Paul Taylor • June 30, 2021 -
FDA
Q&AFDA wants to require timely updates, patches for legacy devices: cyber chief
Kevin Fu, acting director of device cybersecurity, spelled out the agency's plans to protect aging devices from hackers. There's no current statutory requirement compelling manufacturers to address the problem.
By Greg Slabodkin • June 30, 2021 -
Kendall Davis/MedTech Dive
Roundup: Trial results, looming product releases fuel diabetes tech competition
In the first half of the year, the space is meeting Wall Street's high expectations for 2021. Here's a roundup of MedTech Dive's coverage of the market, including from this week's American Diabetes Association meeting.
June 30, 2021 -
Robotic Surgery/MedTech Dive
Robotic abdominal surgery has no advantage over open, laparoscopic surgeries: meta-analysis
The review found of 39 studies reporting surgical complications, just 10% showed fewer complications with robot-assisted surgery. The analysis was published in the Annals of Internal Medicine.
By Greg Slabodkin • June 29, 2021 -
Medtronic smart insulin pen improved time in target blood glucose levels: study
The medtech giant's trial results come as competition in the space is intensifying. Eli Lilly and Bigfoot Biomedical, partnered with Abbott, are also prioritizing the technology.
By Ricky Zipp • June 29, 2021 -
FDA nod in sight, Insulet's Omnipod 5 boosts time in range in diabetes subset
The trial results show improved health outcomes in a crucial patient population for the company: individuals requiring multiple daily injections of insulin.
By Susan Kelly • June 28, 2021 -
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Sponsored by PenrodVirtual selling expected to be the new normal of medtech sales in 2022
Due to the challenges of COVID-19 restrictions, medtech companies are beginning to replace siloed platforms that rely on in-person visits, disconnected systems and outdated marketing tech.
June 28, 2021 -
Nevro's painful diabetic neuropathy data marred by disappointing Q2 forecast
CEO Keith Grossman said he's "frankly disappointed" at the pace of the recovery, suggesting the company may miss its sales target. Shares were down nearly 6% Monday morning.
By Nick Paul Taylor • June 28, 2021 -
EU clarifies Eudamed rules for legacy and custom-made devices
The Medical Device Coordination Group has provided information on products placed on the market under frameworks other than MDR and IVDR, which the advisers said should be registered in the database.
By Nick Paul Taylor • June 25, 2021 -
Getty Images
More than 1/3 of health organizations hit by ransomware last year, report finds
Of those attacked, 65% said the criminals were successful in encrypting their data, according to the report from cybersecurity company Sophos.
By Rebecca Pifer • June 24, 2021 -
Medicare lacks cyber oversight of hospitals' networked medical devices: OIG
Without proper cybersecurity controls, these devices can be compromised with the potential for patient harm, according to the HHS watchdog. OIG wants CMS to do more to address hospital vulnerabilities.
By Nick Paul Taylor • June 24, 2021 -
Boston Scientific spends $295M to snap up rest of cardiac ablation maker Farapulse
The deal adds to the medtech's electrophysiology portfolio in an increasingly competitive space that includes Medtronic and Johnson & Johnson.
By Ricky Zipp • June 24, 2021 -
Stefani Reynolds / Stringer via Getty Images
Contentious device breakthrough payment rule codified in Cures 2.0 proposal
The measure would sidestep CMS' delay of the MCIT pathway, which grants Medicare coverage to FDA-approved breakthrough devices.
By Nick Paul Taylor • June 24, 2021 -
An Rong Xu via Getty Images
AdvaMed urges Biden to prioritize medical supplies as industries suffer shipping constraints
CEO Scott Whitaker said transport challenges, including shipping container shortages and insufficient trucking capacity, have impeded the ability of medtechs to deliver products while also significantly driving up costs.
By Ricky Zipp • June 23, 2021 -
Pear secures $400M to scale up digital therapeutic business in SPAC deal
The developer of the first three FDA-authorized prescription digital therapeutics has ambitions to grow sales from a projected $4 million this year to $125 million in 2023.
By Nick Paul Taylor • June 23, 2021 -
Deep Dive
Legacy medical devices, growing hacker threats create perfect storm of cybersecurity risks
Aging medtech and increasingly sophisticated criminals are leaving hospitals highly vulnerable to attacks.
By Greg Slabodkin • June 22, 2021 -
Philips recalls 2021
Philips recall could be $300M opportunity for ResMed: analysts
The Baird analysts warned it's a heavy lift, suggesting hitting a $100 million to $300 million range would require about 10% to 20% of the impacted Philips devices to transition to ResMed.
By Nick Paul Taylor • June 22, 2021 -
Medicare CGM eligibility widened in potential boon for Abbott, Dexcom
CMS opened up coverage for therapeutic continuous glucose monitors, eliminating a rule that patients must use a blood glucose monitor and require at least four self-monitoring blood glucose tests per day to have devices covered.
By Ricky Zipp • June 18, 2021 -
FDA seeks feedback on distinction between device remanufacturing and servicing
The long-awaited draft guidance is meant to clarify a blurry line between the two processes. The Medical Imaging and Technology Alliance contends remanufacturing is being done by unregulated third-party device servicers.
By Nick Paul Taylor • June 18, 2021 -
Roundup: Medtronic's HVAD recall problems continue following patient injuries, deaths
One year after Medtronic pulled the heart pump off the market, there have been two Class I recalls following reports of patient injuries and deaths. Here is a collection of MedTech Dive's coverage of the HVAD saga.
Updated June 27, 2022 -
Alex Wong via Getty Images
Hip, knee bundled pay program results similar as voluntary or mandatory: JAMA study
The results of a University of Pennsylvania analysis of more than a million Medicare claims for joint replacement surgery lend support to CMS' expected policy shift toward more mandatory bundled payment arrangements.
By Susan Kelly • June 16, 2021
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