Edwards tricuspid valve replacement cut leakage for 98% of participants in early trial results

A total of 56 patients were examined 30 days after a transcatheter tricuspid valve replacement procedure. Edwards now plans to start a pivotal trial, examining the procedure in 775 patients.

By Ricky Zipp • May 17, 2021

Edwards withstands winter lows, grows Q1 sales on electives recovery

CEO Michael Mussallem said volumes grew gradually through March after a significant drop, continuing the early trend of procedure-dependent medtechs reporting a return of non-emergency procedures.

By Ricky Zipp • April 21, 2021

FDA puts Medtronic Valiant Navion stent graft recall in Class I category

The action, which comes amid one patient death in a clinical trial, deprives Medtronic of a source of sales growth. After securing 2018 approval, then-CEO Omar Ishrak talked up the device's potential to drive incremental growth.

By Nick Paul Taylor • April 12, 2021

FDA-medtech consortium offers strategy to boost patient engagement in clinical trials

The MDIC report, created by a working group including Exact Sciences and J&J, follows the agency's late 2019 draft guidance meant to increase the influence of patients in medical device clinical trial design. 

By Nick Paul Taylor • April 7, 2021

Nevro shares full diabetic neuropathy SCS data as it pursues blockbuster opportunity

If successful, the company would be the only FDA-approved spinal cord stimulation device with an on-label indication for painful diabetic neuropathy. Nevro estimates a market worth up to $5 billion, but analysts are skeptical.

By Nick Paul Taylor • April 7, 2021

Boston Scientific links just approved liver cancer device to improved survival

Analysts at Evercore ISI estimate FDA clearance for the radioactive glass beads opens up a $150 million U.S. market opportunity, although they note lack of data from a randomized trial "could be a factor in modeling adoption."

By Nick Paul Taylor • March 26, 2021

AstraZeneca, Oxford vaccine prevents COVID-19 in big US study amid controversy overseas

A two-shot regimen was 79% effective at protecting people from COVID-19, which should support the fourth clearance of a vaccine in the U.S. and calm safety concerns abroad. 

By Ben Fidler • March 22, 2021

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

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