FDA OKs alternative to open heart surgery for Abbott's HeartMate 3 pump

The less invasive procedure allows the left ventricular assist device to be implanted via an incision between the patient's ribs, an approval Medtronic received for its HeartWare product in 2018.

By Susan Kelly • Jan. 8, 2020

EU group offers guidance on meeting MDR's cybersecurity standards

The document says it's important to reference the International Medical Device Regulators Forum's cybersecurity guidance, and policies like the General Data Protection Regulation and the EU Cybersecurity Act "might apply in parallel."

By Susan Kelly • Jan. 7, 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

Medtronic warns of Mazor X detachment issue in robotic surgery

In an urgent field safety notice, the medtech giant said one piece may detach from the OR table unexpectedly, which could lead to blunt injury to a patient.

By Maria Rachal • Jan. 7, 2020

Latest FDA clinical decision support software draft a step forward, industry says

The American Medical Association wrote the guide could "lead to the proliferation of CDS tools for 'non-serious conditions' that are faulty, inaccurate, and without validation, potentially leading to patient harm."

By David Lim • Jan. 7, 2020

OrthoPediatrics sells Vilex assets in preparation for more M&A

The device maker sold the adult piece of the Vilex business, which it acquired last year, for $25 million.

By Nick Paul Taylor • Jan. 7, 2020

Industry, doctors, patients diverge on FDA outline for breast implant labels

The Medical Device Manufacturers Association took issue with inclusion of the term "breast implant illness" and called a proposal that manufacturers continually update risk info "impracticable."

By Maria Rachal • Updated Feb. 3, 2020

Terumo subsidiary gains FDA nod for aneurysm flow diverter

MicroVention earned its third premarket approval in under two years. Stryker, Johnson & Johnson and Medtronic are also focused on treatments.

By Susan Kelly • Jan. 6, 2020

Simplified devices, pharmacy access among 2020 catalysts for diabetes tech: analysts

Baird Equity Research analysts expect this year will represent "an even greater technological leap forward than in 2018," previously thought to be the most significant new product launch year in more than a decade.

By Susan Kelly • Jan. 6, 2020

NuVasive replaces CFO with former Mallinckrodt executive

The company sought to allay concerns arising from the C-suite change by reiterating its expectation that 2019 revenues will total $1.16 billion.

By Nick Paul Taylor • Jan. 3, 2020

FTC slaps Stryker, Wright Medical with second request

In a second amendment to its tender offer statement for Wright Medical, Stryker acknowledged a Wright shareholder's class action lawsuit alleging Wright's solicitation statement was false and misleading.

By David Lim , Maria Rachal • Updated Jan. 23, 2020

FDA finalizes exemptions for certain devices from 510(k) review

Newly exempted devices are still subject to other regulatory controls, such as good manufacturing practice requirements.

By Susan Kelly • Dec. 31, 2019

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

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