The Latest
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REVA files for bankruptcy after bioresorbable scaffold flops
The company pinned its failure to grow sales on the European Society of Cardiology's preference for conventional drug-eluting stents.
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Amid Q4 letdown, Boston Scientific aims for $1B mark in structural heart
CEO Mike Mahoney, speaking at the J.P. Morgan Healthcare Conference, partly blamed underperformance on a December slowdown in the U.S. defibrillator business, but said the company is still sorting out reasons for the softness.
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Health IT to lead 2020 deals, KPMG predicts
The repeal of the medical device tax could boost investor interest in hot areas like non-invasive diagnostics, robotic surgery and AI-enabled devices, although health IT, pharma and biotech appear to be drawing more excitement.
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LabCorp, Quest push for M&A-driven growth despite difficulties closing deals
“It’s still a very fragmented marketplace,” said Quest CEO Steve Rusckowski at JPM. "Trying to get people to move fast has been harder than I would have anticipated,” LabCorp's new CEO Adam Schechter told investors.
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ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations
A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.
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Nevro, NuVasive, Integra, others preview earnings at JPM
Wednesday's lineup of medtech presenters includes Exact Sciences, Intersect ENT, ICU Medical and handheld ultrasound device maker Butterfly.
UPDATED: Jan. 15, 2020 at 9:20 a.m. -
Robotic surgeries surge to 15% of all procedures, despite limited evidence
Robot-assisted procedures jumped from accounting for 1.8% of all general surgeries in 2012 to 15.1% in 2018. Closer monitoring is needed to ensure clinical benefits and safety are prioritized, researchers said.
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Medtronic at JPM: More tuck-ins under Martha and key trial results ahead
Incoming CEO Geoff Martha also said management agrees "certain pockets of the company probably have a little bit too much bureaucracy."
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RTI Surgical inks $490M deal to sell OEM unit to private equity
The divestiture will turn Michigan-based RTI into a pure play spine company with up to $200 million in cash, as private equity groups show growing interest in the medical technology sector.
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Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound
FDA's device center issued just nine warning letters in the most recent fiscal year, down from 81 in 2015. But with a major reorganization complete, regulators say they can respond to compliance issues more quickly.
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FDA guidance on catheters zeros in on testing, coatings
The agency wants to see consistency across 510(k) submissions for various types of Class II percutaneous transluminal angioplasty balloon catheters.
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FDA OKs Abbott clinical trial of MitraClip in moderate risk patients
The transcatheter mitral valve repair device, used to treat primary mitral regurgitation, is currently only indicated for patients at a prohibitive risk for surgery.
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MedTech Europe pushes urgent action to keep devices on sale after MDR
The trade group wants the EU to fix perceived problems with the grace period to allow devices to stay on the market and be reviewed by an MDR-designated notified body.
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Enrollment has ended in Essure postmarket study, FDA says
Bayer discontinued sales of the permanent birth control implant more than a year ago but continues to study its safety profile, as directed by the agency.
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Intuitive closes 2019 by topping Q4 expectations
Intuitive's 19% procedure growth helped it increase sales by 22%, according to preliminary results. But Medtronic, J&J and CMR Surgical are among the competitors that will press for share in the next few years.
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JenaValve TAVR tech amid wave to get breakthrough device status from FDA
Other devices recently designated include 3Derm Systems' AI to detect skin cancers, KDx Diagnostics' urine-based bladder cancer test, and Reflow Medical's retrievable stent for use in below-the-knee peripheral artery disease.
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Alphabet snaps up 2nd ex-ONC head for life sciences team
Vindell Washington is the latest in Alphabet's ongoing campaign to hire top healthcare talent as the Google parent company doubles down on the industry.
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Medtronic buys new spinal cord tech to boost pain therapies unit
Amid a broader slowdown in the spinal cord stimulation market, Medtronic is acquiring technology from Stimgenics that offers a new way of programming its Intellis implant.
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Study links paclitaxel devices to better survival in PAD, muddying debate
New research comes about six months after FDA held an advisory panel in response to a meta-analysis that found an increased risk of death associated with the use of coated balloons and stents in an artery of the lower limbs.
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Adaptive gets CMS coverage for chronic lymphocytic leukemia test
The expanded Medicare policy covers use of the assay in the monitoring of minimal residual disease.
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Abbott sets CFO transition in motion
The company plans to install a new chief financial officer a month before incoming CEO Robert Ford takes the helm.
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FDA OKs alternative to open heart surgery for Abbott's HeartMate 3 pump
The less invasive procedure allows the left ventricular assist device to be implanted via an incision between the patient's ribs, an approval Medtronic received for its HeartWare product in 2018.
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FDA sets March meeting to talk future data strategy
Building on the Technology Modernization Action Plan released last year, the agency said it will engage experts on data quality, stewardship, exchange and analytics.
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Latest FDA clinical decision support software draft a step forward, industry says
The American Medical Association wrote the guide could "lead to the proliferation of CDS tools for 'non-serious conditions' that are faulty, inaccurate, and without validation, potentially leading to patient harm."
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EU group offers guidance on meeting MDR's cybersecurity standards
The document says it's important to reference the International Medical Device Regulators Forum's cybersecurity guidance, and policies like the General Data Protection Regulation and the EU Cybersecurity Act "might apply in parallel."
