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Specialty: Medical Devices
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Total 5 results found since Jan 2013.
Roche Scores EUA for COVID-19 Antibody Test
There were some pretty significant developments in the world of COVID-19 that occurred over the weekend. One of these developments was Roche Diagnostics being granted Emergency Use Authorization (EUA) for the Elecsys Anti-SARS-CoV-2 antibody test.
The antibody or serology test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2.
Roche said it has already started shipping the new antibody test to laboratories worldwide and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in count...
Source: MDDI - May 4, 2020 Category: Medical Devices Tags: COVID-19 IVD Source Type: news
A Temporary Fix for the EpiPen Crisis?
The ongoing saga of the EpiPen shortage crisis took a new turn today as FDA made a move to extend the expiration dates of certain lots of the allergy drug-device combo by four months.
The recent EpiPen shortage has caused FDA to extend the expiration dates of certain lots of the allergy drug-device combo by four months. The products effected are the EpiPen 0.3 mg Auto-Injectors and its authorized generic version. This measure by FDA was made after a review of stability data.
Mylan's product treats life-threatening allergic reactions by automatically injecting a dose of epinephrine, also known as adrenaline. The...
Source: MDDI - August 21, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Report: Mylan may have overcharged US by $1.3B for EpiPen
Mylan (NSDQ:MYL) shares dipped slightly in mid-afternoon trading today after Sen. Chuck Grassley’s (R-Iowa) office released a Health and Human Services estimate claiming that taxpayers overpaid by as much as $1.27 billion for Mylan’s EpiPen device from 2006 to 2016.
The charges stem from Mylan’s decision to classify the emergency allergy auto-injector as a generic, instead of a branded product under the Medicaid Drug Rebate Program. Misclassifying the device allowed the company to pay the government a 13% rebate instead of a 23% rebate. The Centers for Medicare and Medicaid Services repeatedly warned Mylan that the...
Source: Mass Device - May 31, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Wall Street Beat Centers for Medicare and Medicaid Services (CMS) Mylan Source Type: news
EpiPen price hike cost Pentagon millions
Mylan Pharmaceuticals‘ (NSDQ:MYL) 500% price increase on its epinephrine auto-injector cost the U.S Defense Dept. millions, according to data provided to Reuters.
The Pentagon spent $57 million on Mylan’s EpiPen last year, up from $9 million in 2008, largely driven by volume and price hikes that affected prescriptions filled at retail pharmacies. Although the Pentagon gets a government discount for EpiPens from military treatment facilities and by mail order, nearly half of its spending was at retail pharmacies. Recently, it paid an average of $528 for a two-pack of the lifesaving allergy treatment. That&...
Source: Mass Device - October 31, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Centers for Medicare and Medicaid Services (CMS) Mylan Source Type: news
MassDevice.com +3 | The top 3 medtech stories for July 10, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. ACAAI endorses Boston Scientific’s Alair asthma treatment
Boston Scientific said that the American College of Allergy, Asthma and Immunology has endorsed bronchial thermoplasty using the company’s Alair system.
The ACAAI recommends the procedure for patients with severe asthma who ...
Source: Mass Device - July 10, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
