Mercy expands RWE program to capture data from other providers

The expansion of the network follows real-world evidence deals with BD, Johnson & Johnson and Medtronic.

By Nick Paul Taylor • Aug. 16, 2019

UK plans for express medical products shipping service ahead of Brexit

The announcement of the shipping service comes as the government, led by new prime minister Boris Johnson, steps up no-deal scenario preparations and downplays risks.

By Nick Paul Taylor • Aug. 16, 2019

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Hearing industry calls Bose self-fit hearing aid study flawed in complaint to FDA

The Hearing Industries Association letter argues the device's Phase II clinical study "does not provide enough evidence of effectiveness of the self-fitting method given the study's initial reliance on professionals for fitting."

By David Lim • Aug. 15, 2019

FDA taps Type A aortic dissection stent for breakthrough program

Ascyrus Medical's leg up from U.S. regulators follows Health Canada's approval of its device for a rare but potentially fatal condition last December and CE marking in February.

By Maria Rachal • Aug. 15, 2019

Abbott poised to profit from CMS review of TMVR coverage

Analysts at Cowen estimate CMS coverage in a newly considered indication could triple the number of patients eligible for transcatheter mitral valve repair.

By Nick Paul Taylor • Aug. 15, 2019

Industry backs Australia's device identifier plan with caveats

The responses showed broad support for a unique device identification system based on global guidelines, but the Therapeutic Goods Administration also faced some pushback from J&J and Roche.

By Nick Paul Taylor • Aug. 15, 2019

FDA hits medicine cabinet and cart maker Talon with warning letter

The agency found 11 violations of quality system regulations, ranging from failure to follow audit principles and perform risk analysis to inadequate procedures covering design changes and control of nonconforming products.

By Susan Kelly • Aug. 14, 2019

Analysts predict big jump in continuous glucose monitor use

Abbott and Dexcom are likely to dominate the CGM market in the long term. Medtronic is expected to remain the leader in insulin pumps.

By Susan Kelly • Aug. 14, 2019

Stryker acquires maker of device sterilization systems

The deal comes against a backdrop of heightened regulatory scrutiny of duodenoscope reprocessing after a spike in contamination cases and the closure of a Sterigenics​ plant in Illinois that sterilized a wide range of devices.

By Susan Kelly • Aug. 13, 2019

Australia weighs in on paclitaxel-coated balloons

The Therapeutic Goods Administration said data on adverse events in Australia haven't shown a signal like the one described by FDA.

By Susan Kelly • Aug. 13, 2019

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

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 Parduhn • 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