CDC rule removes barrier to sale of escape respirators

The deregulatory action was inspired by concern that underground coal miners could face a dangerous shortage of the breathing devices, relied on as a means of survival in emergencies.

By Susan Kelly • April 22, 2019

FDA clears first medical device indicated for ADHD

The De Novo-winning nerve stimulation system, which can be administered at home in certain patients ages 7 to 12 years old, serves as an alternative to prescription medication in treating attention deficit hyperactivity disorder.

By Maria Rachal • April 22, 2019

Explore the Trendline➔

New 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

Intuitive shares tumble as Q1 earnings miss analyst expectations

The robotic surgery leader reported double-digit growth in procedures, shipments of surgical systems and sales, but the earnings miss reflected rising spending and lower revenues resulting from a shift to leasing.

By Nick Paul Taylor • April 22, 2019

Best Buy, Target jump into at-home device market

The partnership is an example of companies reaching customers through mass retailers, tightening the relationship between healthcare and retail.

By Daphne Howland • April 18, 2019

FDA grants breakthrough status to preeclampsia device

Advanced Prenatal Therapeutics designed the device to remove pathogenic factors from a mother's blood, seeking to prevent a pregnancy condition that can be fatal.

By Nick Paul Taylor • April 18, 2019

WHO weighs in on digital health tools in new report

The World Health Organization reviewed 10 digital health interventions, backing use of mobile devices for functions like clinical decision support and telemedicine. Still, a top official said the strategies are "not a silver bullet."

By Nick Paul Taylor • April 18, 2019

Medtronic posts data on stent grafts and venous closure systems

The endosuture aneurysm repair and chronic venous disease data suggest the efficacy seen earlier in the studies is durable.

By Nick Paul Taylor • April 18, 2019

FDA orders Boston Scientific, Coloplast to pull transvaginal mesh from market

The medtechs have 10 days to submit a withdrawal plan, two months after an agency advisory panel noted a worrisome lack of long-term safety and effectiveness data for the much-litigated pelvic organ prolapse repair devices.

By Maria Rachal • April 17, 2019

Brainlab recalls spine 3D navigation software for incorrect display

The software could display inaccurate information during a procedure that may prevent the surgeon from safely navigating surgical tools inside the patient, causing serious injury or death.

By Susan Kelly • April 17, 2019

AI poised to 'transform' medical imaging, radiology society says

Earlier this month FDA outlined in a white paper its vision for a framework to regulate artificial intelligence algorithms that change based on real-world learning. 

By Susan Kelly • April 17, 2019

Abbott beats guidance in Q1, ramps up full-year earnings forecast

The medical device unit led the way once again with 5.5% growth, largely fueled by fast-rising demand for the company's FreeStyle Libre continuous glucose monitor.

By Nick Paul Taylor • April 17, 2019

FDA progressive device approval proposal raises eyebrows

Former FDA Commissioner Scott Gottlieb told MedTech Dive during his last week in office he believes stepwise approval should only be used for animal drugs, not human medical products.

By David Lim • April 16, 2019

J&J device revenue slumps amid big bet on digital surgery

Growth in contact lenses and atrial fibrillation ablation catheters were bright spots as Johnson & Johnson felt the impact of its first quarter $3.4 billion Auris Health buy and sale of the LifeScan diabetes business.

By Maria Rachal • April 16, 2019

FDA approves post-angioplasty dissection repair device

Intact Vascular's device is approved to treat above-knee tears in the artery wall in peripheral artery disease patients who have undergone balloon angioplasty.

By Susan Kelly • April 16, 2019

Edible hydrogel capsule to treat obesity gets FDA go-ahead

The De Novo-winning Plenity hydrogel capsule releases particles that rapidly absorb water in the stomach to create gel pieces with the firmness of plant-based foods, making you feel full faster.

By Susan Kelly • April 16, 2019

EU device group clarifies incoming database requirements

The publication of the guidelines comes as Europe races to be ready for the implementation of new medical device regulations.

By Nick Paul Taylor • April 16, 2019

CDRH Director Shuren: Safety and innovation are 'two sides of same coin'

The device chief said in a wide-ranging interview with MedTech Dive a major challenge for the agency is fighting the perception that speeding new devices to market comes at the cost of patient safety, or vice versa.

By David Lim • April 15, 2019

Contaminated duodenoscopes linked to 3 new deaths, 45 more infections, FDA says

The agency signaled impatience with manufacturers Olympus, Fujifilm and Pentax for failing to comply with timelines for completing post-market studies.

By Susan Kelly • April 15, 2019

FDA flags breathing tube shortage tied to sterilization plant closing

The temporary scarcity of Smiths Medical tracheostomy tubes, especially for pediatric use, is FDA's first confirmation of a specific device shortage tied to the shutdown of Illinois contract sterilization company Sterigenics.

By Susan Kelly • April 15, 2019

AliveCor's AI software for EKG rhythms gets market OK

FDA posted the 510(k) summary for KardiaAI last week. The software supports analysis of data recorded in compatible formats from ambulatory EKG devices such as event recorders.

By Susan Kelly • April 15, 2019

Digital care coordination software market to top $3B by 2022, but hurdles remain

Driving growth is poor referral management, a desire for real-time communication on patient outcomes and potential savings from improving chronic disease management, according to a Frost & Sullivan report.

By Meg Bryant • April 11, 2019

FDA sounds alarm on unregulated brain injury devices

The agency said Wednesday it is aware of companies marketing smartphone or tablet-based devices claiming to assess or diagnose concussions and other traumatic brain injuries without proper regulatory approval.

By Maria Rachal • April 11, 2019

Avinger's image-guided device for PAD gets FDA nod

The new device is designed to help physicians remove plaque from smaller arteries and builds on the company's technology that produces real-time images from inside the artery.

By Susan Kelly • April 11, 2019

Device tax repeal reintroduced in House, Senate (again)

AdvaMed Chairman and Stryker CEO Kevin Lobo said the repeal of the tax, set to go back into effect at the end of the year, is the top priority for the device lobby. But signs of movement may be months away.

By David Lim • April 11, 2019

Australia stops short of breast implant ban

Diverging from Canadian and French restrictions on certain breast implants, Allergan, Mentor and other manufacturers have 10 working days to provide information before regulators reconsider pulling products from the market.

By Maria Rachal • April 10, 2019