Abbott halts trial enrollment for HeartMate PHP catheter blood pump

The move is due to a report of a device malfunction, amid a history of setbacks for the technology. The study was comparing the catheter head-to-head with Abiomed Impella pumps.

By Ricky Zipp • Updated March 18, 2021

J&J's single-dose coronavirus vaccine becomes third authorized in US

A CDC vaccine panel recommended use of the shot on Sunday following FDA authorization, and McKesson began shipping out doses to states Monday.

By Ned Pagliarulo • Updated March 1, 2021

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Medtronic recalls thoracic stent graft after patient death in clinical trial

The company has informed physicians to immediately cease use of its Valiant Navion system, which received FDA approval in 2018 for the minimally invasive repair of all lesions of the descending thoracic aorta.

By Greg Slabodkin • Feb. 17, 2021

Vaccine makers prepare response as coronavirus mutations raise alarms

So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't.

By Jonathan Gardner • Jan. 28, 2021

Surmodics drug-coated balloon on par with Medtronic's in study

The medtech is looking to distinguish itself from rivals with a lower dose, after a 2018 meta-analysis found a mortality risk for patients treated with paclitaxel-coated balloons or stents in the femoropopliteal artery of the leg.

By Susan Kelly • Jan. 26, 2021

Neuromod portfolios advance at Medtronic, Boston Scientific, Abbott

The flurry of activity is further evidence of the medtech industry’s latest attempts to make progress in a sector criticized as stagnant just one year ago.

By Nick Paul Taylor • Jan. 15, 2021

Philips clinical-grade wearable study in early COVID-19 detection gets DoD funds

The project will assess the FDA-cleared BioSticker, coming a week after the Dutch medtech giant doubled down on remote patient monitoring by scooping up BioTelemetry for $2.8 billion.

By Nick Paul Taylor • Dec. 23, 2020

FDA panel endorses Moderna's coronavirus vaccine

A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the agency within days. 

By Ned Pagliarulo • Updated Dec. 17, 2020

FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval

A panel of independent experts agreed the benefits of vaccination outweigh the risk, convinced by strong data showing the companies' shot to be 95% effective in preventing COVID-19.

By Ned Pagliarulo • Updated Dec. 10, 2020

Registry finds no link between paclitaxel-coated devices and mortality risk: NEJM

The data add to evidence accumulating since a 2018 meta-analysis led the FDA to hold an advisory meeting and add new label warnings, putting pressure on medtechs like Boston Scientific and Medtronic. 

By Nick Paul Taylor • Dec. 9, 2020

iRhythm wearable linked to more afib diagnoses, though road to payer uptake called 'grind'

Analysts were broadly encouraged by the new data, while cautioning that unlocking the market for this population will take time. Wall Street took a wait-and-see approach, with the stock closing down 9% on Tuesday.

By Nick Paul Taylor • Updated Nov. 18, 2020

Medtronic trial suggests cryoablation bests drug therapy in atrial fibrillation

Ablation was successful in 75% of patients at 12 months, compared to a 45% success rate in the drug cohort, according to a company-sponsored study in the New England Journal of Medicine.

By Nick Paul Taylor • Nov. 17, 2020

Moderna says vaccine prevents COVID-19 in large study, spurring hope for several protective shots

The results are on par with those reported by Pfizer and BioNTech last week, which pressured an array of diagnostics stocks. Shares in antigen test maker Quidel opened down Monday.

By Ben Fidler • Nov. 16, 2020

Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills

The Senate appropriations committee released a series of budget proposals for fiscal 2021. FDA's device center is slated for a 5% funding increase, making it one of the only centers set to receive less than requested.

By Nick Paul Taylor • Nov. 11, 2020

Gauss says at-home COVID-19 antigen test comparable to PCR in clinical study

The company has yet to apply for FDA emergency use authorization after a 159-participant study. Such tests may "hold immense power," said Harvard epidemiologist Michael Mina, also warning EUAs are "not exactly a high bar."  

By Greg Slabodkin • Nov. 2, 2020

Robotic surgery pricier, with no measurable benefit in hernias: Cleveland Clinic trial

Certain procedures with Intuitive's da Vinci took 55% longer than those done laparoscopically, which drove up costs. The findings also punctured the perception that robotic platforms may reduce postoperative pain. 

By Nick Paul Taylor • Oct. 22, 2020

FDA, medtechs envision new era for clinical trials amid COVID-19 shake-up

Medtronic, for example, has faced "very significant delays" in getting products approved as a result of research disruptions, the company's VP of global clinical affairs said during a discussion at TCT.

By Maria Rachal • Updated Oct. 20, 2020

Boston Scientific faces TAVR setback vs. Medtronic, 3-year delay to US launch of redesigned valve

The medtech's stock fell 4% on news that its Acurate neo valve did not achieve noninferiority against Medtronic's CoreValve Evolut, and subsequently that the FDA needs more data for a product submission to be successful.

By Maria Rachal • Oct. 16, 2020

Medtronic pits TAVR device against Edwards Sapien 3, eyes challenge to Abbott's MitraClip

The company appears to be doubling down on structural heart competition with a series of investments in the transcatheter aortic valve replacement and mitral valve repair markets.

By Nick Paul Taylor • Oct. 15, 2020

TCT 2020: Abbott devices, TAVR systems headline late breaker lineup

The five-day Transcatheter Cardiovascular Therapeutics event kicked off Wednesday.

By Susan Kelly • Oct. 12, 2020

Medtronic shares early data TAVR works in low-risk bicuspid patients

Authors of the short Medtronic-sponsored trial, published in JAMA Cardiology, suggest the valve may be free of problems that caused early studies of the device in bicuspid disease to report worse in-hospital outcomes.

By Nick Paul Taylor • Oct. 8, 2020

5 ways COVID-19 is reshaping the medtech industry

Remote tech, clinical trials and marketing are a few of the areas disrupted by the pandemic this year — with changes that look set to stick around.

By Maria Rachal , Greg Slabodkin • Oct. 1, 2020

Abbott resurrects resorbable scaffold tech for below-the-knee trial

The medtech previously stopped selling the technology amid evidence it increased the risk of major adverse cardiac events, but recent data has revealed a new BTK opportunity.

By Nick Paul Taylor • Sept. 4, 2020

FDA proposes adding patient voice in device evaluation

The draft guidance comes nearly two years after an advisory committee prioritized greater inclusion of the patient perspective in device design, development and assessment. Two more public meetings are planned.

By Susan Kelly • Aug. 31, 2020

Tandem's artificial pancreas improves glucose control in pediatric trial

Children treated with the closed-loop insulin delivery system spent longer in the target glucose range than peers who just received Dexcom G6 sensors and insulin, the study published in the New England Journal of Medicine found.

By Nick Paul Taylor • Aug. 27, 2020