The Syringe Recall: A Case for Improved Recall Communications
There is an urgent need for a universal electronic platform for recall communications.
Ellume recalls 2.2M home tests due to risk of false positives
The company expanded a recall of its at-home Covid-19 tests due to a manufacturing error. The FDA upped the recall to a Class 1 recall, its most serious level, after noting a higher-than-acceptable false positive rate for the affected tests.
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The 5 Best Medical Billing Outsourcing Companies
Medical billing is a tedious administrative task, but outsourcing it may be the key to increased revenue. Explore the top medical billing outsourcing companies and the benefits of partnering with one.
Medtronic expands recall of MiniMed insulin pumps
Medtronic is expanding a recall of two of its MiniMed 600 series insulin pumps after reports found several had broken retainer rings cracked, resulting in insulin doses that were too high or too low.
Medtronic is recalling a battery pack used in patient monitors
Apparently, the battery packs, used in its Coviden Oridon Capnostream 20 and Capnostream 20p, could cause "thermal damage." The devices are used to check respiratory status and keep tabs on breathing regularity.
Stryker’s OtisMed division fined $80M for distributing knee replacement products without FDA OK
Stryker Corp.’s OtisMed unit will pay $80 million in fines because the division distributed its knee replacement surgery devices without regulatory approval in 2009. Stryker said in a statement that the DOJ acknowledged that OtisMed’s criminal conduct “occurred prior to Stryker’s acquisition of OtisMed and without Stryker’s prior knowledge or acquiescence.” Bloomberg says: OtisMed will pay a fine of $34.4 million […]
Diabetes news: Abbott voluntarily recalls some FreeStyle and FreeStyle Lite test strips
Abbott (ABT) announced the medical device company will voluntarily recall 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips in the U.S. The company said in a statement the test strips may give low glucose readings when used with the FreeStyle Blood Glucose Meter, the FreeStyle Flash Blood Glucose Meter and the OmniPod Insulin Management […]
Solving Healthcare’s Provider Data Problem Starts with Interoperability
Break down the silos. Take control of your provider data.
Atossa Genetics working toward new FDA clearance, 2014 product launches
Atossa Genetics announced their Q3 earnings today, along with an update on their ForeCYTE Breast Health Test recall and plans for product launches and relaunches in 2014. Net loss for the quarter ended September 30, 2013, was $3.5 million, or $0.22 per share, compared with net loss of $1.1 million, or $0.10 per share, for […]
Are recalls preventable? 5 smart comments from a LinkedIn conversation you should be following
Last week, we learned Q2’13 saw a five-period spike in medical device recalls. On LinkedIn a few weeks prior, Medical Devices Group leader Joe Hage posed this question to the group: “Are recalls preventable?” The discussion that follows is robust, smart and sometimes a bit heated. Here are five smart comments from a LinkedIn conversation […]
Meddevice companies made most recalls in Q2 in 5 quarters, but half the number of units recalled in Q1
Last quarter was the highest in more than a year for recalls–up more than 30 percent from Q1, according to a report out from Stericycle ExpertRECALL. Q2’s 411 recalls only accounted for 9.2 million units, though–a 50 percent decrease from Q1. Of the 174 companies to issue recalls this quarter, nearly 40 percent issued more […]
Recall manager: More device and pharma firms dealing with multiple recalls at the same time
For drug and device companies, a product recall is bad. Dealing with multiple recalls at the same time is worse. Trying to manage either scenario without a plan is nightmare territory. That’s what ExpertRECALL wanted to illustrate during a mock recall held last month in Indianapolis. The company devoted a half-day of the Bio/Pharmaceutical and […]
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Navina’s AI Copilot Eases the Value-Based Burden, Study Shows
A new independent study from Phyx Primary Care’s Innovation Lab points to measurable improvements in physician burnout, documentation efficiency, and key VBC metrics among primary care practices.
St. Jude Medical CEO: When it comes to the Durata lead, facts have been very friendly to us
On Wednesday, St. Jude Medical CEO Dan Starks fielded a couple of questions related to its Durata ICD lead on its fourth-quarter earnings call, although there were none on a possible recall of the product, despite my expectations. The Durata ICD lead has been troubled by its association with a recalled, previous-generation ICD lead and […]
J&J negotiating possible $2 billion implant settlement: Bloomberg
(Reuters) - Johnson & Johnson is negotiating a potential $2 billion settlement with patients who received its recalled artificial hip implant, Bloomberg News reported on Friday, citing five people familiar with the matter. J&J has offered to pa...
Stryker recalls models of waste management product that did not have requisite 510(k)s
Stryker issued an urgent medical device recall notice Tuesday noting that it was expanding the recall to newer models of a waste management product recalled previously because it was selling those products without the necessary regulatory clearance. The recall of the Neptune Rover Waste Management System appears to be a worldwide recall. The devices are […]