Medtechs, working with FDA, offer guidance for remote control of medical devices during pandemic

GE Healthcare, Medtronic, Philips and ResMed are among those that have modified products with such capabilities to create safe physical distance between providers and COVID-19 patients.

By Greg Slabodkin • Dec. 2, 2020

Digital therapeutic De Novos climb with FDA nod to IBS treatment

Despite a series of first-of-their-kind authorizations for such tech, total 2020 De Novo OKs currently match a 2019 low in recent years.

By Maria Rachal • Dec. 1, 2020

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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

Zimmer puts up $250M in surgical device deal, Boston Scientific nets $800M in BTG pharma sell-off

The pandemic hasn't stopped M&A in the medtech industry, with Zimmer Biomet adding to its sternal closure device lineup via A&E Medical and Boston Scientific streamlining business with a sale to specialty pharma group SERB.

By Nick Paul Taylor • Dec. 1, 2020

iRhythm gains UK support for EKG system while awaiting key final rule from CMS

The ambulatory cardiac monitoring system is one of just six medtech products recommended this year in guidance from the U.K. National Institute for Health and Care Excellence. The focus is on individuals with suspected arrhythmias.

By Maria Rachal • Dec. 1, 2020

Nevro Q4 sales to drop as COVID-19 headwinds stiffen: analysts

If the change in tone reflects growing unwillingness of patients to get elective care as cases surge, as Baird analysts believe, the update could have implications for other medical device companies.

By Nick Paul Taylor • Dec. 1, 2020

Hospitals adopt new round of elective surgery restrictions, brace for Thanksgiving COVID-19 surge

The American College of Surgeons is among those placing new emphasis on factoring healthcare worker wellbeing into capacity decisions.

By Maria Rachal • Nov. 25, 2020

Medtronic ends earnings season with mixed results vs. TAVR rival Edwards

The medtech giant's financials reported Tuesday, with a month more of COVID-19 trends factored in compared to competitors, also show some divergence in the spine and neuromodulation markets.

By Nick Paul Taylor • Nov. 25, 2020

Breast cancer tech among FDA's latest breakthrough nods

Over the past month, designations for speedier review have also ranged from a migraine treatment to tissue regeneration tech for spinal cord injuries.

By Susan Kelly • Nov. 24, 2020

Medtronic details diabetes, TAVR offensives as COVID-19 recovery progresses

Q2 data shows how Medtronic's turnabout has been faster than expected, but the company declined to give future guidance because of the global coronavirus resurgence, CEO Geoff Martha said.

By Greg Slabodkin • Nov. 24, 2020

Medical device makers get more flexibility with value-based care in Stark, anti-kickback final rules

The changes include two safe harbor pathways and "allow you to do things that otherwise might violate the kickback statute or the Stark Law. So, that is always welcome in the industry," one lawyer said.

By Ricky Zipp • Nov. 24, 2020

NEJM commentary calls for 510(k)s for OTC hearing aids after senators pan FDA delay to rule

While critics of the delay acknowledged FDA's coronavirus-related workload this year, the agency has failed to come through with the draft regulation required by a 2017 law.

By Nick Paul Taylor • Nov. 23, 2020

Abbott on track to top Q4 CGM sales estimates, rise in US FreeStyle Libre scripts suggests

UBS analysts predict the franchise will grow around 40% in the quarter, well above estimates, based on an increase in prescriptions for the new integrated continuous glucose monitor.

By Nick Paul Taylor • Nov. 23, 2020

J&J readies rivals to da Vinci and Mako, eyeing new markets for robots

Johnson & Johnson won't begin marketing its orthopaedics platform until 2021, with general surgery offering Ottava a few years behind, but its Monarch robot targeting lung cancer diagnosis continues to gain ground.

By Maria Rachal • Nov. 20, 2020

MedTech Europe backs proposed EU Health Union but flags potential hangups

The trade group fears moving responsibility for administering the IVDR and MDR expert panels to the European Medicines Agency could slow deployment.

By Nick Paul Taylor • Nov. 20, 2020

Notified bodies report early success with remote audits but challenges remain

While there have been benefits to going remote during the pandemic, 57% of those polled by a European trade group say they take longer than on-site assessments and most encounter problems due to poor network connections.

By Nick Paul Taylor • Nov. 20, 2020

Older patients less willing to have elective procedures as COVID-19 surges: survey

Patient sentiment has deteriorated since September, according to findings from Needham, even as medtech companies have taken steps to encourage a return to care.

By Nick Paul Taylor • Nov. 19, 2020

Hospitals across US cancel elective procedures — again

Although distinct from wholesale shutdowns earlier this year, health systems from Chicago to El Paso are again putting off non-emergency care, which often includes joint replacement surgeries.

By Hailey Mensik • Nov. 18, 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

Boston Scientific calls it quits on Lotus Edge TAVR program

Shares fell 10% after a voluntary recall led Boston Scientific to end the product line entirely. The surprise move gives Medtronic and Edwards Lifesciences the opportunity to gain back ground in the near term.

By Maria Rachal • Updated Nov. 17, 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

FDA draft guidance expands electromagnetic compatibility advice for medtechs

A new document builds on a very brief final guidance from 2016, as the agency looks to gather the right information on how devices function in intended electromagnetic environments.

By Nick Paul Taylor • Nov. 17, 2020

BD's Alaris infusion pumps flagged for cybersecurity vulnerability

The Department of Homeland Security alert scored the issue 6.5 out of 10 and said a successful attack that exploited the weakness could force operators to manually program the pumps.

By Nick Paul Taylor • Nov. 13, 2020

3 ways Biden's COVID-19 approach could impact medtech

A new administration — regardless of who's in power — means device makers can anticipate shifts at key government agencies like the FDA.

By Maria Rachal , Greg Slabodkin • Nov. 12, 2020

Dialysis device maker Outset Medical tops revenue targets in first quarter since IPO

The portable dialysis system company benefited from the pandemic environment, which is driving increased interest in home dialysis and growth in its base business. 

By Nick Paul Taylor • Nov. 12, 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