Medical Devices: Page 148
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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 -
Explore the Trendline➔
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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 -
Jacob Bell / BioPharma Dive
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 -
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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 -
Jacob Bell
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 -
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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
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 -
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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 -
LifeScan deal challenges Abbott, Dexcom for CGM market
The former Johnson & Johnson unit has teamed with Sanvita Medical to sell continuous glucose monitor systems in North America and some European countries beginning in 2020.
By Nick Paul Taylor • May 23, 2019 -
Medtronic results build case for renal denervation device
One study linked Symplicity to a reduced occurrence of subclinical atrial fibrillation in a subset of high-risk patients.
By Nick Paul Taylor • May 23, 2019 -
FDA on Abiomed right heart device: patient selection is key
In its latest update on the safety of Impella RP, FDA said Monday the most recent post-approval study results for the device show comparable survival outcomes among patients who would have qualified for premarket studies.
By Susan Kelly • Updated Dec. 3, 2019 -
Abbott releases 30-day data on tricuspid valve repair system
The late-breaking study results released at the EuroPCR meeting in Paris showed the investigational device reduced tricuspid regurgitation at 30 days.
By Susan Kelly • May 22, 2019 -
Biotronik stent bests Medtronic in study of small-vessel lesions
Evidence from a sub-group analysis of a three-year clinical trial supports the theory that stents with very thin struts are less likely to require repeat revascularization in patients.
By Nick Paul Taylor • May 22, 2019 -
Jacob Bell
Integra LifeSciences recall draws Class I label from FDA
The New Jersey-based device maker began recalling 42,100 cerebrospinal fluid drainage systems after receiving complaints about broken stopcocks.
By Nick Paul Taylor • May 22, 2019 -
Jacob Bell / BioPharma Dive
Stryker wins approval for brain aneurysm stent system
The product, designed to treat wide-neck intracranial aneurysms, adds to the company's rapidly growing neurovascular portfolio.
By Susan Kelly • May 21, 2019 -
J&J's Auris unveils early results on Monarch robot for lung procedures
The FDA-cleared robotic platform successfully localized lung nodules in 92% of patients, Auris Health reported at the American Thoracic Society Conference.
By Susan Kelly • May 21, 2019 -
Varian ups presence in India with $283M acquisition
The Palo Alto, California-based radiation oncology systems maker will acquire Cancer Treatment Services International, which operates a network of care facilities concentrated in South Asia.
By Maria Rachal • May 21, 2019 -
Cook lands rights to sell single-use duodenoscope in US
A deal with with Danish single-use device maker Ambu sets Cook up to challenge Olympus, Fujifilm and Pentax for the duodenoscope market with a product free from contamination concerns.
By Nick Paul Taylor • May 21, 2019
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