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Siemens to acquire Corindus Vascular Robotics for $1.1B
Corindus filed a 510(k) for a neurovascular indication for its CorPath GRX robotic platform in February, but received a request from FDA for additional data in April.
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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.
UPDATED: Aug. 8, 2019 at 10:08 a.m. -
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.
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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."
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FDA grants breakthrough status to Perfuze stroke device
The startup is attempting to enter a field fought over by Johnson & Johnson, Medtronic and Stryker.
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Guardant Q2 sales soar on liquid biopsy adoption
The company touted results this week from a study showing its blood-based Guardant360 assay compared favorably to standard-of-care tissue testing of solid tumors for a biomarker used to predict response to immunotherapy.
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iCubate lung infection test secures FDA breakthrough status
The in vitro diagnostics maker said it can accelerate diagnosis and treatment of a disease that affects more than 80,000 people in the U.S.
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Boston Scientific snags BTG for $4.2B
The Federal Trade Commission cleared the merger and the deal is now slated to take effect Aug. 19, Boston Scientific said in an SEC filing Wednesday, a month after it addressed antitrust concerns by divesting its beads business.
UPDATED: Aug. 7, 2019 at 8:56 a.m. -
Healthcare AI funding hits new high as sector matures
Startups in the sector raised $864 million across 75 venture capital-backed deals and financing during the second quarter, beating the previous quarterly high by about $100 million.
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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.
UPDATED: Aug. 7, 2019 at 9:34 a.m. -
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.
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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.
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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.
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CMS eases breakthrough device path to reimbursement in final rule
Beginning with applications for FY 2021, FDA-designated breakthrough devices won't be held to CMS' "substantial clinical improvement" standard to qualify for coverage through an alternative payment pathway for new technologies.
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FDA posts draft guidance on magnetic resonance safety
The recommendations are expected to replace a 2014 document and come amid a rapid rise in the use of MRI-compatible medical devices.
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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.
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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.
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Abiomed investors spooked by drop in heart pump adoption
After losing more than 25% of its stock value last week, shares in Abiomed inched up Monday morning on news that CMS will not cut reimbursement in fiscal year 2020 for the primary code covering Impella heart pump procedures.
UPDATED: Aug. 5, 2019 at 11:29 a.m. -
Teleflex recalls more endotracheal tubes, now linked to four deaths
The devices, used to administer anesthesia and provide ventilation during surgical procedures, may become disconnected from the breathing circuit, resulting in insufficient oxygenation.
UPDATED: Aug. 5, 2019 at 8:52 a.m. -
UnitedHealthcare's depression test decision boosts Myriad's prospects
While Medicare only permits psychiatrists to order the test, the private payer will reimburse requests from all providers.
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Hill-Rom picks up wearable ventilator maker in $130M deal
The medical equipment and systems company announced it's adding Breathe Technologies to its respiratory care business, part of a unit that contributed to Hill-Rom's 3% quarterly revenue growth reported Friday.
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Japan to reimburse TransEnterix's robotic surgery system
The decision positions the company to compete with Intuitive Surgical in one of the largest markets for the platforms.
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US to slap 10% tariffs on $300B in Chinese goods as medtech seeks details
The tariffs are set to take effect on Sept. 1. AdvaMed said it "strongly opposes tariffs by both sides on medical technology products" and is lobbying U.S. trade negotiators.
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Data breaches in 2019 already double all of last year
The single largest data breach stemmed from a hack of a major medical collections agency working for companies including Quest and LabCorp, the report from Protenus found. Twenty million patient records were affected.
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Dexcom CGM adoption booms as it looks to 'aggressively' pursue Type 2 market
Coming off another beat-and-raise quarter, the company remains focused on adding users via the pharmacy benefit channel, Medicare population and international markets as a potential iCGM rival from Abbott looms.
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