Intuitive gets FDA go-ahead for robotic system sealing instrument, power generator

The devices add to the capabilities of Intuitive's da Vinci X and Xi as the robotic surgery giant works to grow recurring revenues and stave off competition.

By Nick Paul Taylor • Dec. 2, 2019

EU MDR delay for certain Class I devices moves forward: what it means for manufacturers

"The Corrigendum will remove some pressure for these manufacturers" to obtain a CE Certificate of Conformity from a notified body, Fabien Roy and Elisabethann Wright of Hogan Lovells said.

By Dana Elfin • Nov. 27, 2019

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

Roundup: How major medtechs fared in Q3

A still robust economy, coupled with caution regarding a potential recession, is working in medtech's favor as the sector outperforms the S&P 500.

By Maria Rachal • Nov. 27, 2019

B. Braun recalls blood sets over risk of leakage and infection

Leaks in the 43,000 devices could delay treatment or lead to blood infections.

By Nick Paul Taylor • Nov. 27, 2019

With 6 months until new EU medical device rules, what's the state of play?

Preparing for the May 26, 2020, implementation of the EU's Medical Device Regulation hasn't been easy, given the lack of notified bodies designated to review devices under the more stringent standards.

By Dana Elfin • Updated Nov. 26, 2019

Standards body urged to add device identifiers to insurance claims forms

Incorporating unique device identifiers into claims documents is expected to improve patient safety and save the healthcare system money by allowing better tracking of implants by brand and model.

By Susan Kelly • Nov. 26, 2019

FDA approves J&J spinout's device for kids with recurring ear infections

The agency heralded Tusker Medical's ear tube delivery system as the first for use in young children with local anesthesia in a doctor's office, which could widen treatment access for a "susceptible patient population."

By Maria Rachal • Nov. 26, 2019

Medtronic warns of fault with MiniMed insulin pumps

The structural fault could cause too much or too little insulin to be delivered. The issue stems from the loss of or damage to the retainer ring, which Medtronic said can break if the pump is dropped or bumped.

By Nick Paul Taylor • Nov. 26, 2019

5 insights into Dexcom's year ahead from CEO Kevin Sayer

The diabetes tech giant has "not turned on the faucet full blast" in marketing to new customers. Sayer told MedTech Dive he plans to change that as Dexcom quadruples its sensor production capacity for its continuous glucose monitors.

By Maria Rachal • Nov. 25, 2019

Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis

Antibiotic resistance was higher in hospital-associated infections linked to use of devices like central lines, ventilators and urinary catheters, according to data collected from more than 5,600 sites between 2015 and 2017.​

By Susan Kelly • Nov. 25, 2019

FDA launches pilot to speed new ethylene oxide sterilization methods

Device makers should also reduce paper in packaging "as soon as possible" to trim the amount of the gas required for effective sterilization. The agency also named its innovation challenge winners.

By David Lim • Nov. 25, 2019

AdvaMed lobbied EPA chief Wheeler on cancer report amid delay in ethylene oxide regs

A bipartisan congressional task force is pushing EPA to issue ethylene oxide regulations that rely on EPA's 2016 report on the toxicity of the gas.

By David Lim • Nov. 22, 2019

Merit Medical stent graft system gains breakthrough status

The regulatory leg up for the endoprosthesis for hemodialysis patients comes after a quarter that fell short of Wall Street's expectations.​

By Nick Paul Taylor • Nov. 22, 2019

Medtronic's recovering DCB segment scores FDA approval of IN.PACT AV

The approval allows Medtronic to sell the paclitaxel-coated balloon as a treatment for failing arteriovenous access in dialysis patients.

By Nick Paul Taylor • Nov. 22, 2019

Transcatheter device to treat heart failure gets breakthrough designation

BioVentrix is enrolling 120 subjects in a clinical trial meant to support U.S. marketing authorization for its minimally invasive alternative to conventional surgical ventricular reconstruction.

By Nick Paul Taylor • Nov. 21, 2019

Pulmonary hypertension common in MitraClip patients, increasing mortality risk: JAMA Cardiology

After reviewing more than 4,000 cases of mitral valve repair, researchers proposed exploring intervention with devices like Abbott's MitraClip earlier in disease progression to improve outcomes.

By Nick Paul Taylor • Nov. 21, 2019

Trump FDA nominee Hahn advanced by Senate HELP Committee 18-5

Ranking Member Patty Murray said she would not support the nomination due to a lack of a commitment to back regulations to take non-tobacco flavored e-cigarettes that have not gone under FDA review off the market. 

By David Lim • Updated Dec. 3, 2019

LivaNova to shutter mitral valve replacement line

The London-based medtech couldn't keep up with growing competition from transcatheter mitral valve repair devices and said restructuring its heart valves segment was necessary. About 150 employees could be affected.​

By Maria Rachal • Updated Nov. 20, 2019

FDA flags 2 more deaths, over 60 device failures tied to heart balloon pump

As a software upgrade is in the works for Getinge's Maquet/Datascope ​intra-aortic balloon pump devices, FDA is still trying to determine what is causing the system to shut down while operating on battery power.

By Susan Kelly • Nov. 20, 2019

Hologic unloads underperforming Cynosure medical aesthetics unit

"This divestiture was a long time coming and puts an end to a bad marriage," William Blair analyst Brian Weinstein said of Hologic's $1.6 billion deal in 2017. Now, the company expects $138 million in cash proceeds from its sale.

By Dana Elfin • Updated Dec. 30, 2019

Asian private equity group to buy Lumenis in $1B deal

The maker of minimally invasive devices used in aesthetic procedures competes with rivals like Candela Medical.

By Nick Paul Taylor • Nov. 20, 2019

FDA approves 1st contact lens to slow myopia in children

Concentric rings in the lens focus light in front of the retina in a process that is thought to reduce the stimulus that causes myopia to advance.

By Susan Kelly • Nov. 19, 2019

Incoming Medtronic CEO to prioritize 'aggressive' tuck-in M&A, 'reinvigorating' diabetes unit

Growth accelerated for Medtronic in its recent quarter but competitive pressures in areas like arrhythmia management and diabetes had president and future CEO Geoff Martha pledging to "get back to share-taking mode."

By Maria Rachal • Nov. 19, 2019

AdvaMed wants FDA to define 'significantly' improved for Safer Technologies Program eligibility

Although the trade association said it supports efforts to speed safer medical devices to market, it believes the agency's draft guidance lacks the specificity needed for industry to understand which devices would be eligible.

By David Lim • Nov. 19, 2019

Edwards has edge over Medtronic in TAVR registry studies

The data presented at the American Heart Association meeting favor Edwards' Sapien valve, but confounding factors may explain the differences. Large, randomized trails are needed to generate more evidence, cardiologists said.

By Nick Paul Taylor • Nov. 19, 2019