Medical Devices
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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 -
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
The latest letter to healthcare providers follows the agency's warning in February of a far higher mortality rate seen in post-approval study of Impella RP than was reported in initial clinical trials.
By Susan Kelly • May 22, 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 -
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 -
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 -
Real-world operations: NESTcc director on building a business and the future of device evaluation
The National Evaluation System for health Technology and its real-world evidence projects are finally getting off the ground. Now the center needs to secure industry's buy-in, said Rachael Fleurence, executive director.
By Maria Rachal • May 20, 2019 -
FDA warns diabetes patients against use of unauthorized devices
The agency said it received a report of a patient using a "do it yourself" management system who experienced an insulin overdose.
By Susan Kelly • May 20, 2019 -
Philadelphia jury awards $80M in J&J pelvic mesh suit
Awards in mesh cases against Ethicon in the Pennsylvania court now total $346 million.
By Susan Kelly • May 20, 2019 -
Ra Medical files suit alleging rival interfered with IPO
Separately, Nasdaq notified Strata Skin Sciences on Friday it is out of compliance with the market's continued listing requirements due to delays in filing quarterly and annual reports.
By Susan Kelly • May 20, 2019 -
Express Scripts to launch formulary for apps, medical devices
The pharmacy benefit manager says its new formulary will include digital health solutions for a host of chronic and complex conditions, including diabetes, cardiovascular, pulmonary and behavioral health issues.
By Rebecca Pifer • May 17, 2019 -
Smiths Medical lobbies White House for better device-based opioid alternative reimbursement
The medical device industry is taking an all hands on deck approach to convince CMS for better payment in the Hospital Outpatient Prospective Payment System proposed rule.
By David Lim • May 17, 2019 -
Canada raises medical device regulatory fees
The final fee schedule reflects a compromise after industry pushed back against higher rates initially proposed.
By Susan Kelly • May 17, 2019 -
Newly independent Alcon leans on surgical unit while awaiting key product launches
The full year outlook reflects rising sales of Alcon's PanOptix intraocular lenses, offset by loss of vision care market share.
By Nick Paul Taylor • May 17, 2019
