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

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

Prices soar for new medtech, but payment lags: report

New medtech, especially heart devices, is improving patients' quality of life and helping them live longer, but hospitals are enmeshed in a "reimbursement quagmire," according to a report by consultancy Vizient.

By Susan Kelly • April 10, 2019

CMS floats broadening ambulatory blood pressure monitoring coverage

The proposed decision memo comes nearly a year after the American Heart Association and American Medical Association requested the agency consider expanding reimbursement.

By David Lim • April 9, 2019

FDA warns patients to steer clear of pre-owned test strips

An underground economy is thriving for test strips used by diabetes patients for blood sugar monitoring.

By Susan Kelly • April 9, 2019

Medtronic, Blue Cross strike value-based pact for glucose monitors

The arrangement ties payments to the amount of time a patient's blood sugar stays in a healthy range.

By Susan Kelly • April 9, 2019

Alcon spin-out marks step in Novartis plan to remake business

Alcon will rank as one of the largest eye care device makers globally, with more than 20,000 employees and sales totaling $7.1 billion last year. 

By Ned Pagliarulo • April 9, 2019

Abiomed reports improved survival rates in cardiogenic shock patients

The company said data from an observational database and post-approval studies show development of a best practices protocol can significantly improve patient outcomes.

By Susan Kelly • April 8, 2019

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

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