Thermo Fisher, MedRhythms gain breakthrough device designations

A companion diagnostic for certain brain tumor patients and a digital therapeutic for stroke patients with walking impairments are among the latest technologies tapped by FDA for the priority review program.

By Susan Kelly • June 17, 2020

Endologix stent graft tied to 5 deaths gets high-risk recall label from FDA

The Class I recall marks an escalation of a polymer leak issue first reported in 2018. Endologix now says the leaks are due to a "material weakness," not incorrect use as it originally concluded.

By Nick Paul Taylor • June 17, 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

Heart rhythm bodies see 'clear concerns' with using wearables to detect arrhythmias

A paper published on Monday by the Heart Rhythm Society, along with counterpart groups in Asia, Europe and Latin America, found wearable-triggered false positives can cause unwarranted concerns and screening.

By Nick Paul Taylor • June 16, 2020

Medtronic inks up to $337M in diabetes funding, Blackstone Life Sciences' 1st medtech investment

The announcement came in conjunction with the ADA's Scientific Sessions this weekend, which also featured data on its advanced hybrid closed loop system that will back an FDA premarket approval submission.

By Susan Kelly • June 15, 2020

Paclitaxel-coated balloon, stent labels in Europe to have mortality warning update

A notice posted by British medical device regulators outlined 12 affected products including Boston Scientific's ELUVIA stent, Cook Medical's Zilver PTX stent, and Medtronic's IN.PACT Admiral balloon.

By Greg Slabodkin • June 15, 2020

Abbott's FreeStyle Libre 2 gets long-awaited iCGM nod from FDA

The designation may stiffen competition for Dexcom, whose G6 device was the sole integrated continuous glucose monitor on the U.S. market. But Abbott's device isn't yet OK'd for use with automated insulin dosing systems.

By Nick Paul Taylor , Maria Rachal • June 15, 2020

Key data on Medtronic's 780G, Insulet's Horizon kick off ADA 2020

Abbott, Dexcom and Tandem will also present results at the virtual American Diabetes Association meeting that runs through Tuesday.

By Maria Rachal • June 12, 2020

CMS to review at-home ventilation of COPD patients amid variability in device use

Findings from a July Medicare Evidence Development & Coverage Advisory Committee meeting and resulting policy changes could potentially impact ResMed and Philips Respironics.

By Nick Paul Taylor • June 12, 2020

Moody's lowers medtech earnings forecast, pegs J&J, Zimmer among hardest hit by COVID-19 fallout

The ratings agency expects the pandemic to curb sales of the large, mostly investment-grade medtechs it covers by 10% this year, with earnings dropping as much as 30%.

By Nick Paul Taylor • Updated June 15, 2020

Surgeons, device makers grow more confident in elective care comeback

As some medtechs indicate forecasts entering Q2 may have been too conservative, a Bain & Co. survey of physicians and administrators suggests rising capacity for elective procedures, albeit without sales reps at full force.

By Maria Rachal • June 11, 2020

MedTech Europe pitches virtual audits to clear MDR coronavirus logjam

The trade group contends technology such as smart glasses and webcams can enable notified bodies to view facilities without having to visit in person.

By Nick Paul Taylor • June 11, 2020

Trump admin encourages return to elective care, with precautions

Major surgeries should still be limited as much as clinically possible among higher risk patients, and facilities should prepare to screen all visitors and staff for symptoms, according to new CMS guidelines.

By Shannon Muchmore • June 10, 2020

Siemens Healthineers, Geisinger ink 10-year digital health partnership

It's one of the medtech's largest partnerships of its kind in North America, as it plans to provide diagnostic imaging and artificial intelligence-enabled applications to the health system over the next decade.

By Greg Slabodkin • June 9, 2020

Edwards wins approval to introduce Sapien 3 valve in China

The transcatheter heart device specialist has been eyeing the wealthy, aging nation's untapped market potential for new cardiovascular disease treatments.

By Susan Kelly • June 9, 2020

Boston Scientific secures CMS pass-through nod for single-use endoscopes

The alternative payment pathway gives Medicare beneficiaries access to new devices while the agency is still gathering cost data. The company's Exalt D device is the first single-use, flexible duodenoscope to be cleared by FDA.

By Susan Kelly • June 8, 2020

Surmodics gets CE mark for Abbott-backed paclitaxel-coated balloon

The company will receive a $10.8 million milestone payment from Abbott, which licensed exclusive commercialization rights to the device for peripheral artery disease patients in 2018 in a bid to take on Medtronic's drug-coated balloons.

By Maria Rachal • June 8, 2020

Insulet's pivotal study back on track, setting up Horizon launch in early 2021

The diabetes device maker fixed a software glitch it found with the smartphone-controlled automated insulin delivery system three months ago. Abbott and Dexcom plan to make their CGM tech compatible with the system.

By Maria Rachal • June 5, 2020

European Commission lays out timeline for next steps toward MDR, IVDR

Targets for issuing upcoming implementing acts, including those on reprocessing single-use medical devices and the delayed Eudamed database, range from the coming quarter to two years from now.

By Nick Paul Taylor • June 4, 2020

PMA major deficiency letters tick up, 510(k) asks for info flatline: MDUFA report

FDA's second quarter report for fiscal 2020, which covered January through March, also showed that the agency still has many guidance document priorities to check off its list.

By Maria Rachal • June 4, 2020

Medtronic, Titan Medical ink robotics development, license agreements

The beleaguered robotic surgery company said Thursday it will receive up to $31 million from Medtronic's licensing of technologies. It's the medtech giant's second robotics deal this year as it works to launch its own soft tissue robot.   

By Greg Slabodkin • June 4, 2020

Haemonetics unveils back-to-back divestitures of blood supply assets

The company saw a 25% to 30% drop in April plasma collections and is now preserving cash, but Wall Street analysts see a few upcoming growth drivers.

By Nick Paul Taylor • June 4, 2020

CMS relaxes more value-based model rules in wake of pandemic

Payments and reporting rules related to joint replacements, end stage renal disease and diabetes care were among those addressed.

By Shannon Muchmore • June 3, 2020

Fitbit, NASA get latest FDA emergency authorizations for ventilators

Fitbit's invention is considered an emergency resuscitator, the same label given to a device manufactured by Boston Scientific. NASA's breathing machine builds on a version of a full-fledged ventilator that gained FDA's OK in April.  

By Nick Paul Taylor • June 3, 2020

JAMA reanalysis goes against 5-year Abbott stent study findings, upping odds of death

The JAMA Internal Medicine report raised doubts about the claim percutaneous coronary intervention is noninferior to bypass surgery and fueled a call for changes to guidelines.

By Nick Paul Taylor • June 3, 2020

Many heart device trials 'small and fragile,' come with misleading spin: JAMA study

A JAMA Internal Medicine review of 216 trials of invasive cardiovascular interventions also found commercial sponsor involvement linked to more distortion or misrepresentation of the data.

By Nick Paul Taylor • June 2, 2020