Medical Devices: Page 148
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EMA posts draft guidance on drug-device combinations
The European Medicines Agency published the text to inform companies of their obligations under the regulations set to come into force across the continent next year.
By Nick Paul Taylor • June 4, 2019 -
Multi-cancer blood test shows early promise at ASCO
Grail, with backers including Amazon, Bill Gates, Alphabet venture arm GV, J&J and Celgene, said it would move forward with testing based on positive early data presented in a poster at the cancer meeting.
By Susan Kelly • June 3, 2019 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Device makers could feel pinch from Mexico tariffs
Medtech companies with manufacturing facilities in Mexico include Intuitive Surgical, Medtronic, Stryker and Teleflex, according to analysts.
By Susan Kelly • June 3, 2019 -
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 -
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
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