UK regulators reassure medtech sector about Brexit impact

The MHRA expects little to change until 2021 but the risk of significant near-term upheaval remains.

By Nick Paul Taylor • Aug. 7, 2018

FCC seeks comments on $100M telehealth pilot

The commission noted many low-income consumers, especially in rural areas, lack access to affordable or adequate broadband.

By Susan Kelly • Aug. 6, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

NIST offers 'how to' for securing EHRs on mobile devices

Such devices are ubiquitous in healthcare, raising concerns about security and privacy of personal health information.

By Meg Bryant • Aug. 3, 2018

Abbott device to treat Parkinson's now MRI-compatible

Medtronic's deep brain stimulation system was approved in 2002 to treat advanced Parkinson's disease. Abbott acquired its system through its purchase of St. Jude.

By Susan Kelly • Aug. 3, 2018

CMS clears payment for Boston Scientific's newly bought Sentinel

The ruling by the agency was a reversal from an earlier draft and came the day BSX closed its buy of Claret Medical, which makes the device.

By Kerry Dooley Young • Aug. 3, 2018

Industry urges Congress to ease clinical lab pay cuts

The medical device and hospital industries are among those arguing that under the first six months of new reimbursement rates, labs have cut staff, resulting in limited or ended home care visits for homebound patients.

By David Lim • Aug. 3, 2018

EMA faces higher staff losses ahead of move to Amsterdam

The regulator is putting business continuity plans in place, as it expects to lose up to a third of its workforce.

By Suzanne Elvidge • Aug. 2, 2018

Baxter gets CE mark for Evo IQ smart infusion pump

The clearance marks the start of a series of planned regulatory submissions for the device, which will potentially compete with those made by rivals B. Braun and BD.

By Nick Paul Taylor • Aug. 2, 2018

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

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

Patients often choose higher-cost locations for MRIs, study finds

Referring physicians have more influence over a patient's decision than out-of-pocket costs, according to the report from the National Bureau of Economic Research.

By Les Masterson • July 31, 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

Gottlieb teases guidance on continuous trials, touts surrogate endpoints

In a self-described "tweetorial," the FDA chief said modernizing clinical trials could help cut costs.

By Lisa LaMotta • 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

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

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

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 Parduhn • July 30, 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

Pharma, medtech spending accounted for 28% of CME funds in 2017

This was the fourth consecutive yearly increase in medical education spending from industry.

By Rebecca Pifer Parduhn • July 26, 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

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