FDA nod in sight, Insulet's Omnipod 5 boosts time in range in diabetes subset

The trial results show improved health outcomes in a crucial patient population for the company: individuals requiring multiple daily injections of insulin.

By Susan Kelly • June 28, 2021

Nevro's painful diabetic neuropathy data marred by disappointing Q2 forecast

CEO Keith Grossman said he's "frankly disappointed" at the pace of the recovery, suggesting the company may miss its sales target. Shares were down nearly 6% Monday morning.

By Nick Paul Taylor • June 28, 2021

Public Citizen calls for top FDA officials to resign following Alzheimer's drug approval

The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.

By Jacob Bell • June 16, 2021

FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device

The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect. 

By Nick Paul Taylor • June 14, 2021

Dexcom shares clinical data on G7 CGM ahead of next-gen showdown with Abbott

The results compare favorably to data on Abbott’s Libre 2, further setting the stage for the release of one of the most anticipated new products of 2021 in the diabetes tech market.

By Nick Paul Taylor • June 4, 2021

An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?

Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it. 

By Ben Fidler • June 3, 2021

In first, FDA approves KRAS-blocking cancer drug from Amgen

After decades of scientists unsuccessfully targeting the KRAS gene, Lumakras is the first drug proven effective. The FDA Friday also approved companion diagnostics from Qiagen and Guardant Health.

By Ned Pagliarulo • Updated May 29, 2021

Medtronic steps up robotics bet as its challenger to Intuitive starts clinical trial

The medtech giant seeks to double or triple sales in its 2023 fiscal year. However, analysts warned that near-term investments will pressure margins in the short term.

By Nick Paul Taylor • May 28, 2021

FDA draft guidances lay out postmarket medical device data requirements

Building on existing policy, one proposal deals with rules for Class II and III products while another relates to PMAs. 

By Nick Paul Taylor • May 27, 2021

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