Nvidia, American College of Radiology partner on AI platform

The computer graphics chipmaker and doctors group are working on an open architecture artificial intelligence system to help radiologists create diagnostic algorithms at their local institutions.

By Susan Kelly • April 8, 2019

Medtronic analysis tracks reduced strokes in HVAD patients

Ailing from declining sales of its left ventricular assist devices, the company said a retrospective analysis showed blood pressure management helped reduce serious strokes in patients implanted with its HeartWare system.

By Susan Kelly • April 8, 2019

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

Medtronic touts pain pump cost effectiveness for cancer patients in JAMA

While the medtech giant is likely to push its pain pump as an alternative to oral opioids, the National Comprehensive Cancer Network only recommends such targeted drug therapy for a subset of patients.

By David Lim • April 8, 2019

Canada, France take hard action on textured breast implants

Australia's Therapeutic Goods Administration called a meeting of its BIA-ALCL expert working group to "inform decision making" in response to recent reviews of breast implants by FDA and other international regulators.

By Maria Rachal • Updated April 8, 2019

Australia strategizes to tighten medical device oversight

Regulators are considering mandating greater clinical evidence for certain high-risk devices, including spinal implants, diabetes management devices, medical devices used for IVF and companion diagnostics.

By David Lim • April 5, 2019

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

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