Medical devices in South Korea – compliance with UDI requirements for IMDIS

Health authorities around the globe, including South Korea's Ministry of Food and Drug Safety (MFDS), have implemented Unique Device Identifier (UDI) database systems for submitting regulatory-mandated medical device product data. 

July 12, 2021

Abbott's Alere settles with DOJ for $38.75M over defective coagulation test allegations

The Justice Department accused Alere of concealing the defect for years despite knowing the tests were linked to over a dozen deaths and hundreds of injuries. Abbott noted the product was discontinued and never sold by the company.

By Nick Paul Taylor • Updated July 13, 2021

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

FDA flags biocompatibility concerns linked to NuVasive's Precice devices

The agency is recommending physicians stop implanting new stainless steel devices. NuVasive voluntarily removed the products from the U.S. market in February.

By Nick Paul Taylor • July 9, 2021

Stryker inks $15M settlement to resolve Conformis patent dispute

The pact comes around 14 months after Zimmer Biomet agreed to pay the relatively small orthopaedic player $9.6 million to close a similar dispute. Conformis sued J&J's DePuy Synthes in April.

By Nick Paul Taylor • July 8, 2021

EU experts challenge notified body in first opinion on clinical evidence under MDR

The independent panel wants to see an extended study with at least another four months of data on the Class III implantable xenogeneic bone graft. This is the first real-world look at the scrutiny process mandated by the new rules.

By Nick Paul Taylor • July 7, 2021

FDA finalizes guidance on form, content of unique device identifiers

The final text responds to, but in some cases holds firm against, concerns raised by groups including AdvaMed about the 2016 draft and also adds a new section on standalone software.

By Nick Paul Taylor • July 7, 2021

As EU-wide health technology oversight law nears passage, industry is not pleased

If passed, the legislation mandates European Union clinical assessments of certain medical devices to inform national-level pricing and reimbursement decisions.

By Nick Paul Taylor • July 6, 2021

Medtronic's recall of unsterilized angiography guidewires labeled Class I event by FDA

The action comes a month after a series of recalls led the device maker to pull its HeartWare HVAD pump from the market and four months after it told doctors to stop using its Valiant Navion thoracic stent graft system.

By Susan Kelly • July 6, 2021

Dexcom CEO on the Type 2 population, the Super Bowl ad and pandemic momentum

Kevin Sayer called Type 2 a "tremendous market opportunity" and said direct-to-consumer advertising is worth some controversy.

By Ricky Zipp • July 6, 2021

Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods

Neuroelectrics, Neuros Medical and Onward are among those that secured the regulatory privilege, which speeds the review process for unmet medical needs.

By Nick Paul Taylor • July 2, 2021

Biden admin unveils new ESRD payment model in health equity push

Tweaks to the end-stage renal disease model alter scoring methodology to incentivize dialysis providers to lower disparities in home dialysis and kidney transplant rates among patients from disadvantaged communities.

By Rebecca Pifer • July 2, 2021

PMA apps could hit record in 2021, pressuring a pandemic-stressed FDA

Despite increased workloads from the coronavirus crisis, the agency is also on track to issue record numbers of safety warnings and letters to healthcare providers in 2021, according to a Wells Fargo analysis.

By Nick Paul Taylor • July 2, 2021

Supreme Court redefines limits on patent attacks by inventors in Hologic decision

The High Court upheld the doctrine that stops inventors challenging their own patents but placed limits on its use.

By Nick Paul Taylor • June 30, 2021

FDA wants to require timely updates, patches for legacy devices: cyber chief

Kevin Fu, acting director of device cybersecurity, spelled out the agency's plans to protect aging devices from hackers. There's no current statutory requirement compelling manufacturers to address the problem.

By Greg Slabodkin • June 30, 2021

Roundup: Trial results, looming product releases fuel diabetes tech competition

In the first half of the year, the space is meeting Wall Street's high expectations for 2021. Here's a roundup of MedTech Dive's coverage of the market, including from this week's American Diabetes Association meeting.

June 30, 2021

Robotic abdominal surgery has no advantage over open, laparoscopic surgeries: meta-analysis

The review found of 39 studies reporting surgical complications, just 10% showed fewer complications with robot-assisted surgery. The analysis was published in the Annals of Internal Medicine.

By Greg Slabodkin • June 29, 2021

Medtronic smart insulin pen improved time in target blood glucose levels: study

The medtech giant's trial results come as competition in the space is intensifying. Eli Lilly and Bigfoot Biomedical, partnered with Abbott, are also prioritizing the technology.

By Ricky Zipp • June 29, 2021

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

Virtual selling expected to be the new normal of medtech sales in 2022

Due to the challenges of COVID-19 restrictions, medtech companies are beginning to replace siloed platforms that rely on in-person visits, disconnected systems and outdated marketing tech. 

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

EU clarifies Eudamed rules for legacy and custom-made devices

The Medical Device Coordination Group has provided information on products placed on the market under frameworks other than MDR and IVDR, which the advisers said should be registered in the database.

By Nick Paul Taylor • June 25, 2021

More than 1/3 of health organizations hit by ransomware last year, report finds

Of those attacked, 65% said the criminals were successful in encrypting their data, according to the report from cybersecurity company Sophos.

By Rebecca Pifer • June 24, 2021

Medicare lacks cyber oversight of hospitals' networked medical devices: OIG

Without proper cybersecurity controls, these devices can be compromised with the potential for patient harm, according to the HHS watchdog. OIG wants CMS to do more to address hospital vulnerabilities.

By Nick Paul Taylor • June 24, 2021

Boston Scientific spends $295M to snap up rest of cardiac ablation maker Farapulse

The deal adds to the medtech's electrophysiology portfolio in an increasingly competitive space that includes Medtronic and Johnson & Johnson.

By Ricky Zipp • June 24, 2021

Contentious device breakthrough payment rule codified in Cures 2.0 proposal

The measure would sidestep CMS' delay of the MCIT pathway, which grants Medicare coverage to FDA-approved breakthrough devices.

By Nick Paul Taylor • June 24, 2021