Medical Devices: Page 137
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Jacob Bell/MedTech Dive
FDA may change how it announces PMA, HDE decisions
Under a proposed rule, notice of approvals and denials would no longer be published quarterly in the Federal Register.
By Susan Kelly • Dec. 17, 2019 -
J&J vision vet named B. Braun Medical CEO
B. Braun Medical is the latest in a wave of major medtechs to announce a key C-suite change. Medtronic, Abbott, BD and CMR Surgical have all announced CEO transitions for 2020.
By Maria Rachal • Dec. 17, 2019 -
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 -
EU Parliament finalizes 4-year MDR delay for some Class I devices
The delay will help slightly reduce the crush of products needing notified body review by May 26, 2020.
By David Lim • Updated Dec. 17, 2019 -
Tandem wins FDA go-ahead for 1st interoperable, automated insulin dosing software
The clearance of Tandem’s Control-IQ algorithm is part of a broader regulatory vision for people with diabetes to have the freedom to pair their preferred glucose sensing and insulin delivery devices.
By Maria Rachal • Dec. 16, 2019 -
Dexcom CEO on remote monitoring outage: ‘No excuses. We can do better’
The diabetes device maker said Friday it’s accelerating plans to install an in-app alert system to report loss of system functionality. Eli Lilly announced Monday its future insulin delivery platforms will integrate with Dexcom CGMs.
By Susan Kelly • Dec. 16, 2019 -
Dekra Netherlands notified body gains EU MDR designation
With less than six months until manufacturers must comply with the new EU Medical Device Regulation, eight notified bodies have been formally authorized to review devices.
By Maria Rachal • Dec. 16, 2019 -
Boston Scientific gets 1st US disposable duodenoscope clearance
SVP of Endoscopy Art Butcher told investors last June the single-use duodenoscope could represent more than a $1 billion market opportunity.
By David Lim • Dec. 16, 2019 -
FDA moves to electronic premarket submissions
The switch to an electronic format is expected to speed the premarket application process, lower costs, reduce errors and free up storage space.
By Susan Kelly • Dec. 16, 2019 -
FDA qualifies tool for assessing safety of implanted devices
The technology from ZMT Zurich MedTech is designed to support the preparation of MRI radiofrequency results.
By Nick Paul Taylor • Dec. 13, 2019 -
Livongo, Propeller, Omada tapped for Express Scripts digital health formulary
The PBM presented the formulary as a way for health plans and employers to access digital health products that have been vetted for effectiveness, security and value.
By Nick Paul Taylor • Dec. 13, 2019 -
Hahn confirmed as next FDA commissioner in 72-18 Senate vote
Stephen Hahn’s swift confirmation won applause from lawmakers, former FDA commissioners and industry groups.
By David Lim • Dec. 12, 2019 -
Brian Tucker/MedTech Dive
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 -
Courtesy of Sanofi
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 -
Jacob Bell/MedTech Dive
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 Dive
Dexcom 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. 9, 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. 9, 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. 9, 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. 9, 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. 9, 2019 -
Kendall Davis/MedTech Dive
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. 9, 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. 9, 2019
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