Senseonics rolls out 90-day continuous glucose monitoring

The Eversense system will compete with Abbott's FreeStyle Libre monitor, which last month cleared FDA approval.

By Susan Kelly • Aug. 8, 2018

Regs, patient perceptions threaten to throttle neuromodulation growth

Analysts think electrical stimulation devices may struggle to fulfill their commercial potential, challenging the perception that they will soon address a range of unmet neurological medical needs.

By Nick Paul Taylor • Aug. 8, 2018

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

Varian acquires maker of patient monitoring system

The radiation therapy company said the buy expands its motion-management portfolio, part of its cancer care strategy.

By Susan Kelly • Aug. 7, 2018

CMS' Verma stands firm on 2015 EHR deadline, move to open APIs

Meanwhile, the coalition Health IT Now sent a letter to ONC chiding the government for failing to implement information blocking provisions of the 21st Century Cures Act.

By Meg Bryant • Aug. 7, 2018

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

Cardinal Health posts Q4 loss as Cordis struggles

The drug and medical product distribution giant said it is working to turn around the Cordis business under a new management team. 

By Susan Kelly • Aug. 6, 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

BD raises 2018 targets after broad-based Q3 growth

The company has maintained momentum as it spends the year integrating the buys of CareFusion and C. R. Bard.

By Nick Paul Taylor • Aug. 3, 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

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

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