Notified bodies MedCert, BSI gain new EU MDR and IVDR designations

The European Commission's latest nods bring total notified bodies designated for the Medical Device Regulation to nine and for the In Vitro Diagnostic Regulation to three.

By Nick Paul Taylor • Dec. 31, 2019

FDA creates best practices for combination product developers

The 21st Century Cures Act requires the agency to provide final guidance on aspects of the submission process including how companies should obtain feedback.

By Nick Paul Taylor • Dec. 24, 2019

Explore the Trendline➔

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

Medtech manufacturing lags pharma in emerging markets, McKinsey report says

Due to growth through acquisitions, many medtech companies find themselves wrestling with costly, fragmented manufacturing and distribution footprints in need of an overhaul, a new McKinsey analysis suggests.

By Susan Kelly • Dec. 23, 2019

Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels

The public meetings in some cases instigated voluntary recalls and led to required market removals. Nearly all called for further research or more robust medical device monitoring.

By Maria Rachal • Dec. 23, 2019

LivaNova recalls vagus nerve implant amid reset problems

FDA received 14 reports of an error causing the device to stop delivering treatment for major depressive episodes and seizures associated with epilepsy. Four patients have needed revision surgery as a result.

By Susan Kelly • Dec. 23, 2019

Medical device tax disappears, capping decade of industry lobbying

President Donald Trump signed a spending package into law Friday, permanently repealing the ACA tax. The device industry garnered bipartisan backing to nix the 2.3% levy.

By David Lim • Updated Dec. 23, 2019

Wright Medical filings, report hint of rivals to Stryker's $5.4B acquisition

Regulatory filings show as many as five parties besides Stryker, which agreed to pay $30.75 per share, were interested in bidding for Wright.

By Maria Rachal • Dec. 20, 2019

J&J takes over Verb Surgical as Verily exits robotics partnership

The move comes four years after J&J launched the venture with Google-backed Verily, further signaling the medtech giant's play for the digital surgery market after its $3.4 billion acquisition of Auris Health.

By Maria Rachal • Dec. 20, 2019

FDA downclassifies cranial electrotherapy stimulators for anxiety, insomnia

But the agency will still require premarket approval for the devices when intended to treat depression.

By Susan Kelly • Dec. 20, 2019

Delaware court deals blow to Boston Scientific in Channel Medsystems lawsuit

Boston Scientific's attempt to terminate its $275 million acquisition of cryoablation device maker Channel Medsystems was ruled inappropriate by the Delaware Court of Chancery Wednesday. 

By David Lim • Dec. 19, 2019

AI-based heart failure screening from Eko, Mayo Clinic earns FDA breakthrough nod

Digital health company Eko is working with the Mayo Clinic on an algorithm to detect reduced left ventricular ejection fraction, an indicator for heart failure, using a stethoscope during a routine physical exam.

By Susan Kelly • Dec. 19, 2019

FDA warns Conformis over sterilization cycle failures

The customized knee implant maker said it's working "diligently" to address the agency's concerns, also noting that the sterilizers in question are used as a secondary sterilization method in limited circumstances.

By Susan Kelly • Dec. 19, 2019

ONC data reveal safety issues in some EHRs

Potential patient safety issues included laboratory test results not importing into the EHR properly, according to research published this week in JAMA.

By Linda Wilson • Dec. 19, 2019

Telehealth provider Ro to offer De Novo-winning obesity capsule

Biotech company Gelesis is expanding its manufacturing capacity to prepare for a limited launch of the hydrogel treatment in the second half of 2020.

By Susan Kelly • Dec. 18, 2019

FDA may change how it announces PMA, HDE decisions

Under a proposed rule, notice of approvals and denials would no longer be published quarterly in the Federal Register.

By Susan Kelly • Dec. 17, 2019

J&J vision vet named B. Braun Medical CEO

B. Braun Medical is the latest in a wave of major medtechs to announce a key C-suite change. Medtronic, Abbott, BD and CMR Surgical have all announced CEO transitions for 2020.

By Maria Rachal • Dec. 17, 2019

Medical device, insurance and Cadillac taxes repealed in year-end spending bill draft

If enacted into the law as expected, it's a victory for AdvaMed in a years-long battle to scrap the 2.3% levy initially established to help fund coverage under the Affordable Care Act.

By David Lim • Dec. 17, 2019

EU Parliament finalizes 4-year MDR delay for some Class I devices

The delay will help slightly reduce the crush of products needing notified body review by May 26, 2020.  

By David Lim • Updated Dec. 17, 2019

Tandem wins FDA go-ahead for 1st interoperable, automated insulin dosing software

The clearance of Tandem's Control-IQ algorithm is part of a broader regulatory vision for people with diabetes to have the freedom to pair their preferred glucose sensing and insulin delivery devices.

By Maria Rachal • Dec. 16, 2019

Dexcom CEO on remote monitoring outage: 'No excuses. We can do better'

The diabetes device maker said Friday it's accelerating plans to install an in-app alert system to report loss of system functionality. Eli Lilly announced Monday its future insulin delivery platforms will integrate with Dexcom CGMs.

By Susan Kelly • Dec. 16, 2019

Dekra Netherlands notified body gains EU MDR designation

With less than six months until manufacturers must comply with the new EU Medical Device Regulation, eight notified bodies have been formally authorized to review devices.

By Maria Rachal • Dec. 16, 2019

Boston Scientific gets 1st US disposable duodenoscope clearance

SVP of Endoscopy Art Butcher told investors last June the single-use duodenoscope could represent more than a $1 billion market opportunity.

By David Lim • Dec. 16, 2019

FDA moves to electronic premarket submissions

The switch to an electronic format is expected to speed the premarket application process, lower costs, reduce errors and free up storage space.

By Susan Kelly • Dec. 16, 2019

FDA qualifies tool for assessing safety of implanted devices

The technology from ZMT Zurich MedTech is designed to support the preparation of MRI radiofrequency results. 

By Nick Paul Taylor • Dec. 13, 2019

Livongo, Propeller, Omada tapped for Express Scripts digital health formulary

The PBM presented the formulary as a way for health plans and employers to access digital health products that have been vetted for effectiveness, security and value.

By Nick Paul Taylor • Dec. 13, 2019