Roche, GE Healthcare partner on software for tumor boards

The companies expect that combining patient images and data in one location will help cancer teams decide on diagnosis and treatment plans more quickly and efficiently.

By Susan Kelly • June 3, 2019

FDA, industry, advisers say surgical staplers warrant premarket review

Medtronic's Covidien and Johnson & Johnson's Ethicon supply the staplers commonly used in minimally invasive surgeries. The devices will almost certainly be moved to Class II, but special controls are not yet finalized.

By Maria Rachal • May 31, 2019

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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

FDA consults surgical device experts on down-classing certain hemostatic agents

Johnson & Johnson's Ethicon opposes loosening premarket requirements for the devices, maintaining strict controls are needed to ensure patient safety.

By Maria Rachal • May 31, 2019

Wearable glucose monitor wins CE mark, as market gets crowded

Nemaura Medical said it intends for its disposable SugarBeat adhesive patch system to compete aggressively on price.

By Susan Kelly • May 31, 2019

DME industry ramps up lobbying efforts ahead of 2020 proposed rule

Key health lawmakers in the House and Senate are lending support to AAHomecare in its bid to prevent CMS from adding non-invasive ventilators to its competitive bidding program in 2021.

By David Lim • May 31, 2019

GS1 updates UDI guideline to reflect changes to FDA position

Among the almost 20 new subsections added by GS1 are several intended to help device companies get started with UDIs. 

By Nick Paul Taylor • May 31, 2019

WannaCry malware still hitting healthcare organizations

About 40% of healthcare delivery organizations have experienced at least one WannaCry attack in the past six months, largely because of older, unmanaged devices that are difficult to patch, according to cybersecurity firm Armis.

By Shannon Muchmore • May 30, 2019

Medtech groups call for immediate action to avoid EU regulatory cliff

The trade groups think the system is "very unlikely" to be ready in time, raising fears of severe supply disruption.

By Nick Paul Taylor • May 30, 2019

Philips' 3-year data links drug-coated balloon to sustained benefits

The company's low-dose paclitaxel-coated Stellarex beat or matched uncoated balloons on key endpoints, including rates of primary patency and mortality.

By Nick Paul Taylor • May 30, 2019

Medtronic gets FDA greenlight to expand His-bundle pacing portfolio

The catheter system is designed to address the challenges of His bundle anatomy by giving physicians more maneuverability and an adjustable form.

By Nick Paul Taylor • May 30, 2019

Health Canada makes it official: Macrotextured breast implants off the market

Regulators concluded Allergan's Biocell surface implants boost the risk of developing cancer, outweighing potential benefits. The decision conflicts with FDA's stance citing insufficient evidence to support a U.S. ban.

By Maria Rachal • May 29, 2019

FDA experts meet to mull up-classing surgical staplers

Thursday's advisory panel meeting comes amid identification of adverse tissue reactions, infections and complications associated with device malfunction and user error — and 412 reports of death.

By Maria Rachal • May 29, 2019

Test for Parkinson's wins FDA breakthrough designation

Developer Amprion's research focuses on the alpha-synuclein protein as a potential biomarker of the disease.

By Susan Kelly • May 29, 2019

IMDRF posts guidance on custom-made device exemptions

The text covers the eligibility of products for custom-made device pathways and the rules governing such technologies.

By Nick Paul Taylor • May 29, 2019

Neurostimulators could be good match for stroke patients, study suggests

Researchers said a device that aims to increase blood flow to the brain after stroke holds potential for improving functional outcome in patients, although the trial results did not reach statistical significance.

By Susan Kelly • May 28, 2019

FDA clears endoscope connector to prevent fluid backflow

Erbe USA redesigned its device after FDA said the lack of a mechanism to prevent patient fluids from flowing backward and contaminating the irrigation system raised infection risks.

By Susan Kelly • May 28, 2019

Neuromodulation patch for migraine gains De Novo nod

The wireless device from Theranica Bioelectronics requires a prescription and is self-administered at home at the onset of migraine headache.

By Susan Kelly • May 28, 2019

FDA approves Novocure device to treat rare lung cancer

The marketing authorization on the strength of a single-arm study drew criticism, with one prominent physician calling it a "new low" for FDA.

By Nick Paul Taylor • May 28, 2019

Industry slams FDA idea to limit old 510(k) predicates

Between 2015 and 2018, approximately 20% of 510(k) applications were cleared based on a predicate older than 10 years, according to FDA.

By David Lim • May 24, 2019

Faulty platelet counts trigger Class I recall of Beckman Coulter devices

FDA is aware of more than 2,000 U.S. laboratories that may be affected by the inaccurate platelet counting but, so far, the agency hasn't received any reports of serious adverse events.

By Nick Paul Taylor • May 24, 2019

Quality failings spur FDA crackdown on 2 defibrillator businesses

Inspectors identified the same problems in 2018 as two years prior, leading the agency to send warning letters.

By Nick Paul Taylor • May 24, 2019

Medtronic posts flat Q4, but beats Wall Street expectations

Low-risk TAVR data and adoption of Mazor robotics systems were positives for the medtech giant. But tariffs, a sterilization disruption, safety concerns around drug-coated balloons and competition in diabetes created headwinds.

By Maria Rachal • May 23, 2019

Edwards presents 6-month data on Pascal, eyeing MitraClip

The structural heart giant's CE-marked system showed sustained mitral regurgitation improvement in patients. The company is gearing up for a head-to-head trial against Abbott's device, which is the only FDA-approved option.

By Maria Rachal • May 23, 2019

Anti-Kickback Statute safe harbor revisions set for July

The newly released Spring 2019 Unified Agenda lays out government plans to align domestic and international medical device quality systems, define which types of software are considered devices, and more.

By David Lim • May 23, 2019

FDA wants new companies to help test its Pre-Cert Program

One pilot company's CEO told MedTech Dive FDA's search for new companies "is not a surprise to us" and "is a really good thing for the Pre-Cert program."

By David Lim • May 23, 2019