FDA approves Medtronic implant for rare form of hypertension

United Therapeutics will lead commercial promotion of the system, which delivers the drug Remodulin.

By Susan Kelly • Aug. 1, 2018

CSI, Aerolase partner on laser atherectomy device

St. Paul, Minnesota-based CSI competes in the market against much bigger players including Medtronic, Boston Scientific and Phillips.

By Susan Kelly • Aug. 1, 2018

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

Industry balks at FDA's cybersecurity plans

"We already know that FDA will reject premarket submissions if they do not follow the cybersecurity guidance," AdvaMed's Zach Rothstein said.

By Meg Bryant • Aug. 1, 2018

Currency hit wipes out growth at Fresenius' dialysis device unit

The renal disease specialist reaffirmed its 2018 guidance but needs a strong second half of the year to meet its goals.

By Nick Paul Taylor • Aug. 1, 2018

Microsoft files patent for eyeglasses-based blood pressure monitor

The device could free patients from the need to use oscillometric cuffs to track their health.

By Nick Paul Taylor • Aug. 1, 2018

FDA warns about vaginal 'rejuvenation' device claims

The seven device makers notified by FDA are Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

By Susan Kelly • July 31, 2018

Conservative think tank praises CMS proposal on DME bidding

The industry-funded Pacific Research Institute contends that the current bidding system is driving suppliers out of the market and creating supply shortages. The proposal could increase costs to Medicare.

By David Lim • July 31, 2018

MedTech Europe seeks 'urgent' changes to EU regs deadlines

The trade group proposes either stopping the clock on the countdown to the end of the transition periods or delaying the implementation dates for all products, or just legacy products. 

By Nick Paul Taylor • July 31, 2018

Sienna's acne medical device flops in pivotal trials

The California-based company isn't giving up on the product, however. Its CEO said Sienna remains optimistic in its use for hair treatment.

By Andrew Dunn • July 30, 2018

CMS advisers split on procedure volume rules for TAVR

Edwards LifeSciences and Medtronic offered different takes on the current coverage policy.

By Susan Kelly • July 30, 2018

FDA sets 2019 medical device user fee rates

The agency said the base fee for a premarket application received during FY 2019 is $300,000 with the base fee for an establishment registration at $4,548.

By Susan Kelly • July 30, 2018

FDA approves Abbott's blood sugar sensor for 14-day use

The system was the first continuous glucose monitor to eliminate the need for routine finger prick tests. 

By Susan Kelly • July 30, 2018

CMS pitches covering cardiac catheterization at surgical centers

Jefferies analysts expect the agency will eventually add coverage for knee replacements at ambulatory surgical centers.

By Susan Kelly • July 30, 2018

CDHR extends staff training program into 2019

The Experiential Learning Program provides ongoing training for FDA staff about the device development cycle.

By Rebecca Pifer • July 30, 2018

Protecting patients from emergent cybersecurity threats is the shared responsibility of the entire healthcare supply chain

Breaches in medical device cybersecurity pose a significant threat to hospitals and the patients they serve.

By Todd Ebert & Curt Miler • July 27, 2018

ECRI safety panel advises 3 ways to avoid diagnostic testing, medicine mix-ups

"The problem of not closing the loop has a significant impact on patients and caregivers, and can lead to devastating effects on the outcome of patients, workgroup chair Chris Lehmann said.

By David Lim • July 27, 2018

FDA gives draft guidance on atherectomy device submissions

The advice is intended to help manufacturers develop a risk analysis and performance testing strategy for devices used to remove plaque from diseased peripheral arteries. 

By Susan Kelly • July 27, 2018

Baxter boosts 2018 outlook but IV bag supply still under pressure

"We hope that by the end of the year, early next year, MINI-BAG Plus and MINI-BAG will be off allocation," Baxter CEO ​José Almeida told investors.

By David Lim • July 26, 2018

NIH teams with Google Cloud for new biomedical research project

The agency is partnering with Google, which appointed former Cleveland Clinic CEO Toby Cosgrove to advise Google Cloud healthcare initiatives.

By Meg Bryant • July 25, 2018

Roche's rice-sized Lucentis implant headed for advanced testing

Phase 2 data showed the majority of wet AMD patients implanted with the device went six months before needing a refill of the drug.

By Jacob Bell • July 25, 2018

Stryker says Q2 tops goals, will stick to M&A playbook

The device maker boasted of strong demand for its robot for knee surgery but said its spine business remained "challenged."

By Susan Kelly • July 25, 2018

Boston Scientific beats Q2 targets as neuromodulation devices gain share

Demand for the WaveWriter spinal cord stimulator fueled the results. Cardiovascular was the weakest performer.

By Nick Paul Taylor • July 25, 2018

Endomagnetics' Sentimag System scores approval from FDA

The system, which helps guide lymph node biopsies for breast cancer patients undergoing mastectomy, utilizes magnetic rather than radioactive materials.

By David Lim • July 25, 2018

House repeals medical device tax, Senate path muddied

The device industry has successfully put off the tax, one of several imposed on industry in the Affordable Care Act, for years.

By David Lim • Updated July 24, 2018

5 key parts of the FDA Medical Device Safety Action Plan

The ambitious proposal focuses on a total lifecycle approach to device safety.

By Meg Bryant • July 23, 2018