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.

By Nick Paul Taylor • Jan. 15, 2020

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."

By Maria Rachal • Jan. 14, 2020

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

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.

By Susan Kelly • Jan. 14, 2020

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.

By Nick Paul Taylor • Jan. 14, 2020

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.

By Maria Rachal • Updated Jan. 15, 2020

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.

By Susan Kelly • Jan. 13, 2020

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.

By Susan Kelly • Jan. 13, 2020

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. 

By David Lim • Jan. 13, 2020

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.

By David Lim • Jan. 10, 2020

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.

By Nick Paul Taylor • Jan. 10, 2020

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.

By Nick Paul Taylor • Jan. 10, 2020

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.

By Maria Rachal • Jan. 9, 2020

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.

By David Lim • Jan. 9, 2020

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.

By Nick Paul Taylor • Jan. 9, 2020

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.

By Maria Rachal • Jan. 8, 2020

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.

By Susan Kelly • Jan. 8, 2020

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."

By Susan Kelly • Jan. 7, 2020

Medtronic warns of Mazor X detachment issue in robotic surgery

In an urgent field safety notice, the medtech giant said one piece may detach from the OR table unexpectedly, which could lead to blunt injury to a patient.

By Maria Rachal • Jan. 7, 2020

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."

By David Lim • Jan. 7, 2020

OrthoPediatrics sells Vilex assets in preparation for more M&A

The device maker sold the adult piece of the Vilex business, which it acquired last year, for $25 million.

By Nick Paul Taylor • Jan. 7, 2020

Industry, doctors, patients diverge on FDA outline for breast implant labels

The Medical Device Manufacturers Association took issue with inclusion of the term "breast implant illness" and called a proposal that manufacturers continually update risk info "impracticable."

By Maria Rachal • Updated Feb. 3, 2020

Terumo subsidiary gains FDA nod for aneurysm flow diverter

MicroVention earned its third premarket approval in under two years. Stryker, Johnson & Johnson and Medtronic are also focused on treatments.

By Susan Kelly • Jan. 6, 2020

Simplified devices, pharmacy access among 2020 catalysts for diabetes tech: analysts

Baird Equity Research analysts expect this year will represent "an even greater technological leap forward than in 2018," previously thought to be the most significant new product launch year in more than a decade.

By Susan Kelly • Jan. 6, 2020

NuVasive replaces CFO with former Mallinckrodt executive

The company sought to allay concerns arising from the C-suite change by reiterating its expectation that 2019 revenues will total $1.16 billion.

By Nick Paul Taylor • Jan. 3, 2020

FTC slaps Stryker, Wright Medical with second request

In a second amendment to its tender offer statement for Wright Medical, Stryker acknowledged a Wright shareholder's class action lawsuit alleging Wright's solicitation statement was false and misleading.

By David Lim , Maria Rachal • Updated Jan. 23, 2020