OIG finds Pacific Medical received unallowable Medicare payments

The oversight body wants the provider of orthotic braces to refund almost $250,000.

By Nick Paul Taylor • Jan. 4, 2019

What's in a connected medical device? Cybersecurity regulators want to know

FDA could require device makers to publicize a software bill of materials as early as the premarket application process to more quickly identify vulnerabilities in the event of a cyberattack.

By Meg Bryant • Jan. 3, 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

Engineers tout advance in closed-loop neuromodulation system

The device is ready for testing in large animals and potentially humans as a treatment for certain brain disorders.

By Nick Paul Taylor • Jan. 3, 2019

HHS issues voluntary guidelines amid rise of cyberattacks

The department, together with an industry-led task force, compiled best practices on how to protect patients and health systems from growing cyberthreats.

By Samantha Liss • Jan. 2, 2019

Edwards gets FDA nod for Sapien 3 Ultra TAVR device

The agency Friday approved an expanded indication for the company's Sapien 3 transcatheter aortic valve replacement systems for patients with low surgical risk, the first product in the U.S. authorized for that population.

By Nick Paul Taylor • Updated Aug. 16, 2019

GAO: DME supplier pool shrinks under competitive bidding

The program designed to save Medicare money on durable medical equipment found the number of suppliers providing items at adjusted rates in certain areas fell 11% in 2017.

By Susan Kelly • Dec. 26, 2018

FDA reclassifies some electroconvulsive devices in final order

The agency has given manufacturers of devices not covered by the reclassification 90 days to file PMAs.

By Nick Paul Taylor • Dec. 23, 2018

Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018

Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.

By Maria Rachal • Dec. 22, 2018

Government shutdown partially shutters FDA

Hitting its 12th day, 7,053 employees, or more than 40% of the agency's workforce, is furloughed. Commissioner Scott Gottlieb said new guidance on ongoing activities will come later Wednesday.

By David Lim • Updated Jan. 2, 2019

3M completes acquisition of MModal's tech business for $1B

The manufacturer plans to use MModal's cloud-based, conversational AI technology in areas like population health, where 3M is already active. 

By Meg Bryant • Updated Feb. 4, 2019

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

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