Telehealth provider Ro to offer De Novo-winning obesity capsule

Biotech company Gelesis is expanding its manufacturing capacity to prepare for a limited launch of the hydrogel treatment in the second half of 2020.

By Susan Kelly • Dec. 18, 2019

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

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

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

Medical device, insurance and Cadillac taxes repealed in year-end spending bill draft

If enacted into the law as expected, it's a victory for AdvaMed in a years-long battle to scrap the 2.3% levy initially established to help fund coverage under the Affordable Care Act.

By David Lim • Dec. 17, 2019

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

Sunlight 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

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

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

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