FDA-cleared, wearable blood pressure device hits market

A cuff in the wrist watch band inflates to capture systolic and diastolic pressure.

By Maria Rachal • Dec. 21, 2018

Bayer, FDA lengthen Essure postmarketing study to 5 years

The German pharma announced in July it would no longer sell the birth control implant in the U.S. due to falling sales.

By David Lim • Dec. 21, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Health Canada unveils plan to improve medical device safety

The action plan follows an extensive journalistic investigation which uncovered deficient testing of medical devices and underreporting of injuries and deaths resulting from implants.

By Susan Kelly • Dec. 21, 2018

Allergan loses CE mark for textured breast implants, opening EU market

FDA plans to hold a meeting on breast implant safety in 2019 as it "monitors the known risks associated with breast implants, such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymphoma."

By David Lim • Dec. 20, 2018

FDA pitches shorter grace period for UDI revision

The agency wants information submitted to the UDI database to be available to public users within one week, cutting back the 30 days companies have been given to edit their submissions for the last four years.

By Maria Rachal • Dec. 20, 2018

UK regulator puts brakes on Thermo Fisher-Gatan deal

The Competition and Markets Authority said Thermo Fisher’s proposed $925 million acquisition of Roper Technologies' Gatan business could raise prices or lower quality for customers using specialized microscopes.

By Susan Kelly • Dec. 20, 2018

Medtronic launches spinal surgery system with Mazor technology

U.S. patients are now being treated with Medtronic's fully-integrated spinal surgery system, born from the 2018 buyout of Israel's Mazor Robotics.

By Maria Rachal • Updated Jan. 28, 2019

Smith & Nephew completes meniscus repair acquisition

The company said Tuesday its $50 million purchase of Ceterix Orthopaedics has closed, with additional payouts up to $55 million possible over the next five years based on the associated meniscal repair system's financial performance.

By Maria Rachal • Updated Jan. 23, 2019

Aortic stent graft market on path to solid growth

Aortic stent grafts are on track to become a $4.5 billion global market over the next decade, expanding at a compound annual growth rate of 5.4% thanks to advances in product design, according to a forecast by GlobalData.

By Susan Kelly • Dec. 19, 2018

Cardiva wins FDA approval for its vascular closure system

The Santa Clara, California-based company succeeded in its PMA application and can now market the Vascade MVP device for use in electrophysiology procedures.

By Susan Kelly • Dec. 19, 2018

Researchers advance 3D-printed, wirelessly-controlled ingestible

The multi-purpose device could spend a month or more in the stomach as a diagnostic tool or drug delivery mechanism.

By Nick Paul Taylor • Dec. 19, 2018

FDA outlines fast track vision for breakthrough devices

The agency also announced plans to establish a pathway for devices aimed at treating non-life-threatening diseases not eligible for the original program.

By David Lim • Dec. 18, 2018

Medtronic wins FDA OK for InterStim smart programmer

The device giant also got its Navion stent graft system to be included in an aneurysm repair study with Aortica software.

By Susan Kelly • Dec. 18, 2018

FDA addresses manufacturing site changes in final guidance

The agency issued final guidance detailing when a medical device maker that plans a change in manufacturing site should submit a premarket approval application supplement.

By Susan Kelly • Dec. 17, 2018

Nonprofit gets boost to realize automated insulin delivery app

The software is meant to work with multiple insulin pumps and continuous glucose monitoring devices and will be designed for the iOS App Store as an FDA-regulated mobile application, said diabetes technology nonprofit Tidepool.

By Susan Kelly • Dec. 17, 2018

FDA walks back new device class definitions after industry blowback

AdvaMed and the Medical Device Manufacturers Association scored a temporary win after arguing the proposed revisions to the Class III definition could shift more devices into the high-risk category.

By David Lim • Dec. 14, 2018

Medtech industry cheers as NAFTA 2.0 edges forward

Trade groups heralded improved transparency in the recently-signed USMCA, which includes a provision that would enforce more timely reimbursement decision-making by national bodies.

By Nick Paul Taylor • Dec. 14, 2018

FDA touts progress in move toward global device audits

Participating manufacturing sites have spiked this year with 2,629 cumulatively added as of the third quarter of 2018, up from 777 at the end of 2017. 

By David Lim • Dec. 13, 2018

FDA adds information on device BLAs to user fee guidance

The revised document features additional information on the fees for device biologics license applications.

By Nick Paul Taylor • Dec. 13, 2018

FDA rates GE ventilator safety guard recall as Class I event

The recall was triggered after the tech giant discovered the device has the potential to disconnect from the patient's breathing circuit.

By Nick Paul Taylor • Dec. 13, 2018

Apple EKG, artificial iris among FDA 2018 device decisions

De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.

By Meg Bryant • Dec. 12, 2018

Boston Scientific scores US victory in TAVR patents battle

A jury in the U.S. District Court for Delaware determined that the Sapien 3 device from Edwards Lifesciences infringed a Boston Scientific patent in the hotly contested transcatheter aortic valve replacement systems market.

By Maria Rachal • Dec. 12, 2018

UK readies 'worst-case' Brexit plan for medical devices

The government issued an update on its contingency planning if no deal is reached by March 29 for the country to remain part of the EU medicines and medical devices regulatory networks.

By Susan Kelly • Dec. 12, 2018

HIMSS: Health coaching could boost value of wearables

HIMSS surveyed 101 health IT and hospital administrators for the Fitbit-sponsored report, which found that half of hospitals and health systems were already implementing health coaching, or planned to do so.

By Susan Kelly • Dec. 12, 2018

Hospital beds from Hill-Rom get sensor tech

Sensors continually check patients' heart and respiratory rates and alert providers if their vital signs change.

By Meg Bryant • Dec. 11, 2018