Medtronic's Martha teases focus shift on diabetes, robotics

After pandemic-driven delays to its soft tissue robot, the company also told investors it expects to file for a CE mark and a U.S. investigational device exemption in the first quarter of calendar year 2021.

By Maria Rachal • Aug. 25, 2020

FDA-industry group touts real-world evidence framework to speed test development

The Medical Device Innovation Consortium, a collaboration between FDA and diagnostics makers like Abbott and Roche, offers a roadmap as COVID-19 accelerates use of newly generated data to update emergency authorizations. 

By Susan Kelly • Aug. 25, 2020

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

MedTech Europe beats drum for virtual audits, IVDR delay

The one-year delay to the EU Medical Device Regulation has been crucial, but there's been "radio silence" from lawmakers on calls for a similar delay to the In Vitro Diagnostic Regulation, said regulatory lead Oliver Bisazza.

By Maria Rachal • Aug. 24, 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

Intuitive robot may up survival in mouth and throat cancers, but not others: study

Researchers in JAMA Oncology said the findings back a randomized clinical trial for oropharyngeal patients. The da Vinci system had no effect on overall survival in patients with prostate, endometrium and cervix cancers.

By Nick Paul Taylor • Aug. 21, 2020

Eudamed's first section to go live before year's end

The European Commission is ready to move on the initial module of the new safety and performance database, created as part of the incoming Medical Device Regulation, ahead of a March 2021 deadline.

By Nick Paul Taylor • Aug. 19, 2020

CMS urges resumption of essential procedures, organ transplants for ESRD patients

Medicare beneficiaries with end-stage renal disease have 3.5 times heightened risk of COVID-19 infection, according to an HHS analysis of early claims data.

By Maria Rachal • Aug. 18, 2020

FEMA pitches voluntary DPA pact to bolster medical supply chain during pandemic

The Defense Production Act allows private companies to enter agreements with the government while avoiding antitrust liability. AdvaMed wants to participate but FEMA has not yet extended an invite.

By Greg Slabodkin • Aug. 18, 2020

Medtronic seeks leg up in lagging pen market with Companion Medical buy

As Dexcom and Abbott grow share in the continuous glucose monitoring market and Insulet and Tandem forge on with interoperable insulin pump systems, Medtronic is hoping to jump ahead with a connected pen.

By Maria Rachal • Aug. 17, 2020

FDA looks to downclass noninvasive bone growth stimulators, incumbents not on board

The agency made a case for moving the devices to less-rigorous Class II regulation in a proposal opposed by manufacturers with products already on the market such as Orthofix.

By Susan Kelly • Aug. 17, 2020

Surgical robots, early cancer tests top CB Insights digital health startup list

The most promising, as aggregated in annual rankings from the firm, have raised over $20 billion in total funding for more than 600 deals with 900-plus investors.

By Hailey Mensik , Maria Rachal • Aug. 14, 2020

Hospitals, docs pitch roadmap to keep essential surgeries going even with coronavirus surges

While many medtechs cast the worst of the pandemic's impact in the rearview mirror in recent financial reports, concerns from healthcare industry groups reflect a more nuanced picture. 

By Nick Paul Taylor • Aug. 14, 2020

CMS seeks to ease rules on artificial heart, ventricular assist device coverage

Potential eligibility changes for advanced heart failure patients drew positive feedback from Abbott and Medtronic, while removal of a coverage with evidence development policy has been opposed by several cardiologist groups.

By Maria Rachal • Aug. 13, 2020

Watchdog again pushes CMS to add UDIs to claim forms

The HHS Office of Inspector General said that without a place to ask for device-specific information, it's difficult for the agency to track billions of dollars in costs related to failed devices.

By Nick Paul Taylor • Aug. 13, 2020

Coronavirus muddies FDA's trajectory on device warning letters

An agency official said going into 2020 that its devices center would be better equipped to use the compliance tool in a timely fashion. But a dry spell for on-site surveillance may undermine any noticeable rebound.

By Maria Rachal • Updated Aug. 12, 2020

Inari Medical revenue rises in 1st quarterly report since public debut

Specializing in clot-removal devices for pulmonary embolism and deep vein thrombosis, the medtech's CEO downplayed new competition in the space, claiming that only 2% of the $3.6 billion market is penetrated.

By Susan Kelly • Aug. 12, 2020

FDA posts Essure adverse events pulled from social media

The spreadsheet includes details of 53 deaths and 1,376 reports of serious injuries related to the controversial birth control implant but the agency is unsure if it contains duplicate reports. 

By Nick Paul Taylor • Updated Aug. 14, 2020

Medtronic to buy Companion Medical, adding connected insulin pen to diabetes unit

Building on tuck-in acquisitions to a business losing market share in recent years, the deal gives the medtech giant an FDA-cleared device for people with Type 1 or Type 2 diabetes on multiple daily injection therapy.

By Greg Slabodkin • Aug. 11, 2020

Sientra claims market gains as breast implant sales rebound faster than rivals

AbbVie's Allergan and Establishment Labs saw deeper declines in second quarter financials. Sientra CEO Jeffrey Nugent boasted the company is "clearly taking share" from rivals and is hiring to meet demand.

By Nick Paul Taylor • Aug. 11, 2020

Struggling Senseonics allies with blood glucose monitoring giant Ascensia, taps much-needed $80M

Senseonics has failed to dent a market largely commanded by Abbott and Dexcom, despite having a product differentiated from its non-implantable competitors. Analysts believe the new commercialization pact will help.

By Nick Paul Taylor • Aug. 11, 2020

BD's FDA filing to update recalled Alaris pumps delayed by 6 months

The medtech planned to rectify the situation with FDA this year, but that schedule has slipped as it continues system testing and ongoing discussions with the agency. BD estimates remediation costs will total $200 million.

By Greg Slabodkin • Aug. 10, 2020

Notified bodies list for incoming EU regs hits 20 with designation of DQS for MDR

The 16 notified bodies now allowed to complete work under the Medical Device Regulation and the four OK'd under its In Vitro Diagnostic counterpart together meet the goal that authorities had hoped to achieve by the start of 2020.

By Nick Paul Taylor • Aug. 10, 2020

Healthcare gains jobs in July, but still down 800K from February

The latest report shows ambulatory, outpatient, and medical and diagnostic lab service jobs are creeping closer to last year's levels.

By Hailey Mensik • Aug. 7, 2020

Insulet tops Q2 forecasts, as diabetes tech resilient in wake of coronavirus

The number of new insulin pump users was halved in the quarter as COVID-19 reduced typical patient-doctor interactions, but the company kept its $1 billion revenue target for next year.

By Maria Rachal • Aug. 7, 2020

Acutus raises $159M in IPO, challenging medtech leaders for cardiac mapping market

The arrhythmia management company's transition is part of its strategy to crack a market already being fought over by medtech giants Abbott, Boston Scientific, Johnson & Johnson and Medtronic.

By Nick Paul Taylor • Aug. 7, 2020