Saturated oxygen treatment for heart attack wins FDA approval

The catheter-based device from Irvine, California-based TherOx aims to reduce muscle damage by delivering hyperbaric levels of oxygen to heart tissue.

By Susan Kelly • April 5, 2019

New TAVR analysis adds to CMS volume-outcomes debate

A New England Journal of Medicine analysis of nearly 100,000 transfemoral TAVR procedures between 2015 and 2017 showed hospitals with high procedural volumes had significantly better patient outcomes.

By Maria Rachal • April 4, 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

Cryotherapy spray for COPD gets FDA breakthrough boost

A Lexington, Massachusetts manufacturer plans to initiate a pivotal study in patients with chronic bronchitis, hoping the device's application of extreme cold will kill mucus-producing cells.

By Maria Rachal • April 4, 2019

Disposable spinal rod strain sensor earns De Novo clearance

The first-of-its-kind wireless electronic device, developed by Intellirod Spine, clamps onto a standard 5.5-millimeter rod and communicates its measurements to an external reader during surgery.

By Susan Kelly • April 3, 2019

FDA greenlights study of breakthrough device to treat aggressive pancreatic cancer

AngioDynamics' NanoKnife has been indicated for surgical ablation of soft tissue since 2008, and now is cleared for testing in stage 3 pancreatic cancer patients, a talking point on the company's earnings call Tuesday.

By Susan Kelly • April 3, 2019

Industry groups seek safe harbor in comments to senator's cybersecurity query

A think tank's analysis of several organizations' recommendations highlights the need for a national strategy and greater collaboration among various stakeholders.

By Meg Bryant • April 3, 2019

J&J closes Auris Health buy, Advanced Sterilization Products divestiture

Auris' Monarch Platform adds another robotic surgery system to J&J's lineup as the medtech giant bets on digital surgery as a growth driver.

By David Lim • April 2, 2019

Channel Medsystems' endometrial cryoablation device gets FDA nod

The procedure, indicated for women with excessive menstrual bleeding due to benign causes, can be performed in a gynecologist's office and does not require sedation or general anesthesia.

By Susan Kelly • April 2, 2019

FDA gives PMA to injection treatment for knee pain

Fidia Pharma's study of osteoarthritis patients found similar relief from three hyaluronic acid injections per week compared to the company's previously approved iteration, which required five.

By Susan Kelly • April 2, 2019

Bigfoot CEO talks data-driven diabetes care and becoming a service company

In an interview with MedTech Dive, Bigfoot Biomedical CEO Jeffrey Brewer laid out the startup's hopes to crack into the competitive diabetes space.

By Maria Rachal • April 1, 2019

FDA repeals some regs on radiation-emitting devices

The agency said it believes its revised rules will continue to protect patients and health professionals against harmful radiation exposure from electronic products and medical devices.

By Susan Kelly • April 1, 2019

Smith & Nephew picks up pressure injury prevention device

The medtech said Wednesday it completed its acquisition of Leaf Healthcare, following a two-year partnership with the wireless patient monitoring system startup.

By Maria Rachal • Updated April 17, 2019

ECRI Institute launching international device testing lab

The nonprofit patient safety organization will open its first medical device evaluation laboratory outside the United States on April 11 in Selangor, Malaysia, to test products sold in Europe and Asia.

By Susan Kelly • March 29, 2019

FDA floats 5-day notice for device inspections in draft guide

The agency is filling an obligation under the FDA Reauthorization Act of 2017 to adopt uniform standards around not-for-cause inspections. 

By David Lim • March 29, 2019

How AI and machine learning are changing prosthetics

"Our bodies natively have control loops at various levels, and that's really where AI comes into play" in creating next-generation prostheses, said Robert Armiger of Johns Hopkins' Advanced Physics Lab.

By Meg Bryant • March 29, 2019

UK provides more no-deal Brexit advice as logjam drags on

The latest guidance, covering certain types of marketing authorizations and the provision of scientific advice, comes the same week Britain had planned to leave the EU. 

By Nick Paul Taylor • March 29, 2019

Neuronetics gets Japanese coverage for antidepressant device

The coverage decision for the transcranial magnetic stimulation device was supported by an observational study of 307 patients with major depressive disorder.

By Nick Paul Taylor • March 28, 2019

Stryker names J&J lawyer as chief legal officer

Rob Fletcher spent 15 years at Johnson & Johnson, taking on jobs including general counsel for medical devices.

By Nick Paul Taylor • March 28, 2019

Sterilizer plant shutdown prompts FDA action on device shortages

The agency is working with medtech manufacturers to prevent shortages of more than 600 types of devices after the shutdown of a large sterilization operation in Illinois and the planned closing of a second facility in Michigan.

By Susan Kelly • March 27, 2019

FDA clears Zimmer robot that combines brain, spine, knee functionality

The multi-function offering provides direct competition to longtime medtech rival Stryker's Mako robot.

By Susan Kelly • March 27, 2019

FDA's Day 2 of breast implant panel mulls: Who should lead on informed consent?

Agency advisers backed research into breast implant illness and want to bridge gaps in informed consent. But pivotal educational responsibility may fall more with surgeons than regulators, the panel said.

By Maria Rachal • March 27, 2019

CMS pitches new rules for TAVR coverage

Edwards Lifesciences backed a quality-based model to establish which hospitals can perform TAVR. But CMS, echoing Medtronic, contends more data are needed before abandoning the volume-based approach.

By Nick Paul Taylor • March 27, 2019

AdvaMed responds to congressional cybersecurity inquiry

Sen. Mark Warner, D-Va., asked for information to inform the development of a "national strategy that improves the safety, resilience, and security of our health care industry."

By David Lim • March 26, 2019

FDA experts weigh 'man-made' cancer linked to breast implants

Panel members agreed data collection by manufacturers has been deficient and doctors aren’t doing enough to communicate risks to patients, but pushed back on a total ban of textured implants from the U.S. market.

By Maria Rachal • March 26, 2019

CMS greenlights LivaNova's protocol for depression device trial

The U.K. medtech intends to begin enrollment in late 2019, in accordance with the coverage with evidence development framework supporting its vagus nerve stimulation system for use in patients with treatment-resistant depression.

By Susan Kelly • Updated Sept. 6, 2019