Concept Medical nabs breakthrough designation for sirolimus-coated balloon for PAD

If granted FDA marketing authorization, the device may compete with paclitaxel devices sold by BD, Medtronic, Boston Scientific, Philips and Cook Medical.

By David Lim • Aug. 13, 2019

Two more notified bodies designated in EU, but pace still lags

The public database NANDO lists German company Dekra Certification as one of the two notified bodies.

By Dana Elfin • Updated Aug. 14, 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

China grants innovative device designation to Novocure's Optune

Novocure's Chinese partner now gets the opportunity for more contact with regulators and an expedited review in a market estimated at $96.3 billion this year, up from $53.6 billion in 2016. 

By Nick Paul Taylor • Aug. 13, 2019

Ambu to pay $3.3M to settle False Claims Act allegations

The Danish medical device maker is accused of manufacturing products in China and Malaysia and knowingly selling them to U.S. government agencies in violation of the 1979 Trade Agreements Act.

By Susan Kelly • Aug. 12, 2019

NuVasive looks to tech pipeline, overseas expansion in bid for spine market share

Some analysts think achieving revenue growth in the mid-single digits could be a challenge, given tough dynamics in the spinal surgery market.

By Susan Kelly • Aug. 12, 2019

AFib device maker AtriCure to spend up to $300M in SentreHeart buyout

AtriCure announced Tuesday it completed its acquisition of SentreHeart.

By Maria Rachal • Updated Aug. 14, 2019

CMS rejects industry bid to boost payments for device-based opioid alternatives

The agency said evidence submitted was plagued by potential conflicts of interest, inadequate sample sizes and lack of peer review.

By David Lim • Aug. 12, 2019

UBS surgeon poll points to neuromodulation market slowdown

Those surveyed predicted Medtronic would gain the most market share going forward, with Boston Scientific in second place and Abbott in third. 

By Susan Kelly • Aug. 9, 2019

Radiology societies partner with HP on 3D printing registry

Doctors hope the point-of-care data will help determine the value of turning medical images into patient-specific surgical models.

By Nick Paul Taylor • Aug. 9, 2019

MD Anderson taps Hitachi for $159M proton therapy expansion

The cancer center will more than double the size of its existing site to meet rising demand amid mixed messages about the viability of running proton therapy centers in the U.S.

By Nick Paul Taylor • Aug. 9, 2019

California's AG on suing J&J for deceptive mesh marketing, defending ACA

Xavier Becerra also spoke to MedTech Dive about medical product safety.

By Dana Elfin • Aug. 8, 2019

Cardinal Health posts improved Q4, but medical segment still struggling

CEO Mike Kaufmann said many of the challenges the company's medical segment faced were "a little bit self-inflicted."

By Dana Elfin • Aug. 8, 2019

Siemens acquires Corindus Vascular Robotics for $1.1B

The now-completed takeover gives Siemens Healthineers an FDA-cleared and CE-marked system for endovascular coronary and peripheral vascular interventions.

By David Lim • Updated Oct. 29, 2019

Apple, Eli Lilly research whether devices can detect dementia signs

The two companies, along with health tech startup Evidation, found promising initial results but concluded additional research is needed.

By Rebecca Pifer • Aug. 8, 2019

Wright Medical rocked by distributor disinterest and staff losses

"We will be bringing more knife fighters to the knife fight and having more motivated knife fighters in the knife fight," CEO Robert Palmisano said of a rivalry over sales reps.

By Nick Paul Taylor • Aug. 8, 2019

FDA grants breakthrough status to Perfuze stroke device

The startup is attempting to enter a field fought over by Johnson & Johnson, Medtronic and Stryker.

By Nick Paul Taylor • Aug. 8, 2019

TransEnterix admits its robotics system falls short for docs amid sales slump

Senhance has failed to consistently live up to high expectations of physicians used to Intuitive Surgical's devices, TransEnterix execs said. Shares plunged more than 25% on Thursday.

By Nick Paul Taylor • Aug. 8, 2019

FDA to update paclitaxel device labels with mortality signal warning

The agency and manufacturers such as BD, Medtronic and Boston Scientific are planning research into the devices' long-term safety profile using new randomized trials and registry datasets.

By David Lim • Updated Aug. 8, 2019

Insulin pump makers post double digit gains amid record patient additions

Shares in Insulet were up more than 18% Tuesday morning after the company posted 43% revenue growth as more people transition from multiple daily injections. Rival Tandem last week reported a 290% rise in pump shipments.

By Maria Rachal • Aug. 6, 2019

Abbott recommends removal of certain ICDs due to exposed wires

FDA said 108 of the devices are recalled in the United States, of which 31 are implanted in patients. 

By Susan Kelly • Aug. 6, 2019

BD: FDA says Lutonix paclitaxel balloon not approvable for below the knee

BD is working with FDA to determine what additional data is needed to gain the approval, but it is no longer expected this calendar year, executives said on the company's third quarter earnings call.

By Susan Kelly • Updated Aug. 7, 2019

Zimmer hit with $7.7M in damages in hip implant case

The company has now paid more than $400 million in metal-on-metal hip implant cases but still expects to pay out around $130 million more in relation to lawsuits involving Durom Cup and similar devices sold by its Biomet unit.

By Nick Paul Taylor • Aug. 6, 2019

CMS eases breakthrough device path to reimbursement in final rule

As FDA's Breakthrough Devices Program gains in popularity and designated products reach the market, CMS is preparing to offer another benefit: different standards to achieve coverage.

By Maria Rachal • Aug. 5, 2019

VA software workarounds put patient data at risk: OIG

The watchdog made several recommendations after determining fixes intended to allow medical devices to interface with the Veterans Health Administration's EHR system compromised patients’ personal information.

By Susan Kelly • Aug. 5, 2019

B. Braun gets breakthrough status for paclitaxel-coated balloon catheter

The device will be studied for use in treating patients with coronary artery disease who experience in-stent restenosis and could allow patients to avoid an additional stent implant, the company said.

By Susan Kelly • Aug. 5, 2019