Medical Devices
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Hahn confirmed to be next FDA commissioner in 72-18 Senate vote
Stephen Hahn's swift confirmation won applause from former FDA commissioners, lawmakers and industry groups.
By David Lim • Dec. 12, 2019 -
Deep DiveSunlight doesn't dent industry funding to doctors over half-decade
While many manufacturers tell MedTech Dive boosted spending can be attributed to M&A, watchdogs say the payments can sometimes represent a conflict of interest for doctors.
By Maria Rachal , David Lim • Dec. 12, 2019 -
EC medical device group sheds new light on MDR, IVDR sampling codes
The Medical Device Coordination Group also issued a guidance explaining codes used to define the scope of a notified body's designation.
By Nick Paul Taylor • Dec. 12, 2019 -
Sanofi pulls back from 'over-invested' virtual diabetes care venture with Verily
"We recently restructured its ownership with Sanofi to enable Onduo and Verily to move faster, invest more and serve a much broader population of patients managing multiple chronic conditions," Verily said.
By Nick Paul Taylor • UPDATED: Dec. 12, 2019 at 9:35 a.m. -
FDA names Beta Bionics' pancreas tech a breakthrough device
The Boston-based medtech's so-called bionic pancreas incorporates dosing algorithms to automatically control blood sugar levels.
By Susan Kelly • Dec. 11, 2019 -
Deep DiveDexcom app outage highlights communication pitfalls for device makers
"This isn't the main course of what Dexcom offers. It's a side dish," said one parent of a child with Type 1 diabetes. "A good portion of our community has looked at it as a main course."
By Maria Rachal • Dec. 10, 2019 -
Abbott warns of issues with HeartMate 3 cable, mobile power unit
The device maker said there is potential for electrical power loss to the pump if the heart device's cable is improperly connected to the controller. A death rate of 0.05% was associated the issue, according to the company.
By Susan Kelly • Dec. 10, 2019 -
CMR changes CEO ahead of US robotic surgery launch
Per Vegard Nerseth joins the Cambridge, England-based medtech from ABB, a provider of industrial robots.
By Nick Paul Taylor • Dec. 10, 2019 -
Grassley, Warren press FDA to issue over-the-counter hearing aid regulations
The agency missed its estimate that the rules would come out last month, but a spokesperson said that timeline was "not intended to be a precise estimate."
By David Lim • Dec. 09, 2019 -
House bill would speed CMS coverage for breakthrough medtech
The bipartisan legislation, reintroduced on Friday, promises faster access to new medical technologies by requiring Medicare to cover devices approved through FDA's breakthrough pathway during a three-year transitional period.
By Susan Kelly • Dec. 09, 2019 -
FDA proposes alternative 510(k) criteria for MRI coils
The draft guidance would permit manufacturers to use a set of performance criteria to demonstrate substantial equivalence, instead of a direct comparison to a predicate device.
By Susan Kelly • Dec. 09, 2019 -
Impeachment clouds year-end medical device tax repeal, industry priorities
AdvaMed argues the primary obstacle to repealing the tax is not the revenue the government would no longer collect, but a crowded year-end legislative agenda and impeachment proceedings against President Donald Trump.
By David Lim • Dec. 09, 2019 -
Dive Awards
Disruption of the Year: EU MDR notified bodies shortage
The new European Union Medical Device Regulation requires more devices to undergo notified body review than ever before. But there are worries there aren't enough notified bodies to handle the workload.
By Dana Elfin • Dec. 09, 2019 -
Dive Awards
Rivalry of the Year: Abbott and Dexcom's race to dominate CGM
As tech-led diabetes management becomes more mainstream, the "lead horses" in continuous glucose monitor manufacturing have committed to multiplying production capacity and are eyeing expansion into new populations.
By Maria Rachal • Dec. 09, 2019 -
Dive Awards
Executive of the Year: Kevin Lobo, Stryker
Stryker's year was shaped by two of the biggest fruits of the newly minted AdvaMed chairman's dealmaking: expansion of the Mako robot and the addition of Wright Medical.
By Maria Rachal • Dec. 09, 2019 -
Dive Awards
Company of the Year: Edwards Lifesciences
With a laser focus on structural heart care, the company's transcatheter aortic valve replacement technology proved superior and gained approval among patients once considered better candidates for open heart surgery, lifting its stock more than 60%.
By Susan Kelly • Dec. 09, 2019 -
Dive Awards
Regulatory Development of the Year: 510(k) changes inch along
New efforts by FDA to build out the program come years after the Institute of Medicine recommended scrapping it altogether. With more than 80% of devices cleared through the pathway, small changes can be consequential to improving product safety.
By David Lim • Dec. 09, 2019 -
Dive Awards
The MedTech Dive Awards of 2019
From TAVR's takeoff to FDA's new approaches to premarket review, these are the industry forces that left their mark on medical technology this year.
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EPA wants more data from ethylene oxide sterilizers, strikes device-friendly tone
Administrator Andrew Wheeler said "medical device sterilization is vital to protecting public health" on release of a notice ahead of rulemaking that could impact sterilizers reliant on the carcinogenic gas.
By David Lim • Dec. 06, 2019 -
Analysts cool expectations for Edwards' mitral performance
Edwards execs told investors Thursday sales in the transcatheter mitral and tricuspid valve business should roughly double in 2020, but that's after a year when the unit's sales will likely fall short of initial targets.
By Maria Rachal • Dec. 06, 2019 -
Establishment Labs' breast implant opportunity to triple: Jefferies
The analysts predict entering China and the U.S. will open up markets worth close to $1 billion.
By Nick Paul Taylor • Dec. 06, 2019 -
US healthcare spending growth rebounded last year, influenced by insurance tax
Durable medical equipment annual growth jumped from 2.9% in 2017 to 4.7% in 2018.
By Shannon Muchmore • Dec. 05, 2019 -
Edwards projects up to $5B in 2020 sales
Across the aortic, mitral and tricuspid valve therapy markets Edwards Lifesciences targets, the company now expects worldwide opportunities to exceed $10 billion by 2024, per fresh estimates given to investors Thursday.
By Maria Rachal • Dec. 05, 2019 -
FDA grades new Medtronic SynchroMed II recall as Class I event
The voluntary move is the latest in a series of safety actions involving the implantable drug infusion pump, which was the focus of a 2015 consent decree between the company and the government.
By Nick Paul Taylor • UPDATED: Dec. 10, 2019 at 1:17 p.m. -
Vicarious' surgical robot gets FDA breakthrough status
The company also announced Scott Huennekens, former CEO of Google and Johnson & Johnson's robotic surgery joint venture, joined its board of directors.
By Nick Paul Taylor • Dec. 05, 2019
