Medical Devices: Page 144
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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 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
Q&A
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
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