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

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

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

Medtronic hopes for renewed spotlight on dialysis access device with NEJM publication

The company-funded study in the New England Journal of Medicine comes amid widespread disruption of vascular access procedures, and nine months after Medtronic got FDA approval for its IN.PACT AV drug-coated balloon.

By Maria Rachal • Aug. 21, 2020

J&J drops planned 510(k) for Verb-Auris robot, targets 2022 clinical trial start

Talks with the FDA led Johnson & Johnson to opt against trying to bring its general surgery robotics platform to market via the 510(k) pathway. Launch delays buy market incumbent Intuitive some important time, analysts noted.

By Nick Paul Taylor • July 17, 2020

FDA proposes BPH device trial guidance changes as market heats up

The updates come as a swath of companies take aim at the benign prostatic hyperplasia opportunity, which medtechs like Boston Scientific and Teleflex have invested in more since FDA issued development guidance a decade ago.

By Nick Paul Taylor • July 14, 2020

Abbott lays out plan for US study of FreeStyle Libre 3

The sign of potential progress on the medtech's next version of its glucose monitoring technology comes about a month after Libre 2 gained FDA's green light, albeit without the OK to integrate with automated insulin delivery systems.

By Maria Rachal • July 13, 2020

Study design for CVRx device can serve as heart failure model: JACC editorial

Authors from Massachusetts General Hospital and Harvard Medical School say the adaptive design of the BeAT-HF trial used to support an FDA approval last year should be considered for future efforts on heart failure treatments.

By Susan Kelly • July 2, 2020

Medtronic renal denervation registry shows blood pressure improvements persist at 3 years

The update on Thursday from the medtech giant comes months after Symplicity clinical trial results boosted its long-running effort to win FDA approval.

By Nick Paul Taylor • June 26, 2020

Polares raises $40M to target competitive mitral regurgitation market

The medtech plans to finish pilot clinical studies of a transcatheter mitral valve hemi-replacement device, seeking to treat a slice of a population that's proven worthwhile for MitraClip maker Abbott.

By Nick Paul Taylor • June 26, 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