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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

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

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

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

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

Pharma and AI? Let's try augmented intelligence first

Pharma will need collaborations and in-house capabilities to successfully use AI across drug development.

By Lisa LaMotta • July 23, 2018

Bayer to stop selling Essure birth control implant in US

The German pharma said it stands by the product's safety, despite thousands of lawsuits claiming it caused harm.

By Susan Kelly • July 23, 2018

Maryland broadens hospital price transparency initiative

The Maryland Health Care Commission website helps consumers compare prices for common non-emergency procedures.

By Tony Abraham • July 20, 2018

Industry seeks clarity on latest FDA Pre-Cert working model

A software coalition questioned the agency's statutory authority to run a pilot test in 2019.

By David Lim • July 19, 2018

FDA finalizes guidance on use of EHRs in clinical trials

Industry groups including AdvaMed and BIO were broadly supportive of an earlier draft.

By Nick Paul Taylor • July 19, 2018

Calls to revamp physician self-referral law grow louder

Device makers, lab, imaging and hospital companies all back changes to the Stark law, arguing it impedes the move toward alternative payment and value-based care.

By Susan Kelly • July 18, 2018

FDA reiterates concern about off-label use of bile-duct stents

In 2016, Abbott won a whistleblower lawsuit by a former sales representative who accused the company of off-label marketing of bile-duct stents to treat peripheral artery disease.

By Susan Kelly • July 18, 2018

FDA approves Stryker flow diverter, creating competition for Medtronic

The device gives surgeons another way to treat unruptured intracranial aneurysms.

By Nick Paul Taylor • July 18, 2018

Device industry lobbies FDA on combo product classification

AdvaMed argues the agency too often concludes a product’s primary mode of action is that of a drug or biologic rather than a device.

By Susan Kelly • July 17, 2018