Medical Devices: Page 97
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Sponsored by Reed TechMedical 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➔
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TrendlineMedical 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 -
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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 -
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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 -
Q&A
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 -
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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 -
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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 -
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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 -
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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
Q&AFDA 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 Surgery/MedTech Dive
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 -
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Sponsored by PenrodVirtual 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 -
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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 -
Stefani Reynolds / Stringer via Getty Images
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
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