Leukocyte reduction devices recalled for faulty filters

The Food and Drug Administration issued a safety advisory on Haemonetics' Leukotrap RC System, warning that faulty filters in some of the recently distributed devices can result in high leukocyte counts in blood used for transfusions.  By Mackenzie Bean -

How RFID is revolutionizing the healthcare supply chain

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Did you know that waste in the medical device and implantables supply chain amounts to an estimated $5 billion in losses, each year?

How Britain's exit from the EU will affect the drug market

Britain's decision to leave the European Union is causing regulatory uncertainty for drug companies as the London-based European Medicines Agency — equivalent to the U.S.' Food and Drug Administration — will have to relocate to a city in the EU, according to Reuters.  By Mackenzie Bean -

5 latest FDA approvals

Here are the five latest medical devices or drugs approved by the Food and Drug Administration.  By Mackenzie Bean -

Natco Pharma earns FDA approval for ulcer drug

Natco Pharma, an India-based pharmaceutical company, received FDA approval yesterday for its glycopyrrolate oral tablets.  By Mackenzie Bean -

Lupin earns FDA approval for activella tablets

Lupin, a drug company headquartered in Mumbai, recently earned FDA approval for its Amabelz tablets.  By Mackenzie Bean -

AstraZeneca takes $80M hit after CDC rules nasal spray vaccines ineffective

After the CDC announced today that nasal spray vaccines are ineffective in children and should not be used, AstraZeneca said it would have to take an $80 million inventory write-down on stocks of its nasal spray vaccine Flumist Quadrivalent, according to Reuters.  By Mackenzie Bean -

Cochlear Limited offers new sound processor devices for patients with severe hearing loss

Cochlear Limited, a medical device company specializing in implantable hearing solutions, is launching two new bone conduction sound processor devices for patients with high levels of hearing loss.  By Mackenzie Bean -

St. Jude Medical introduces new pacemaker technology

St. Jude Medical, a device maker headquartered in St. Paul, Minn., launched new SyncAV cardiac resynchronization therapy software to treat heart failure in patients who do not respond to conventional treatments.  By Mackenzie Bean -

Saint Francis Hospital and Medical Center earns ultrasound accreditation

Hartford, Conn.-based Saint Francis Hospital and Medical Center recently received a three-year ultrasound practice accreditation from the American Institute of Ultrasound in Medicine.  By Mackenzie Bean -

Opko Health earns FDA approval for hormone treatment

The Food and Drug Administration recently approved a new drug made by Miami-based Opko Health.  By Mackenzie Bean -

Top 15 ways workplaces are countering high prescription drug prices

As prescription drug prices continue to rise, employers are finding greater need to initiate expense saving methods to keep costs controlled.  By Mackenzie Bean -

CytoSorbents cinches $150k grant for universal plasma development

CytoSorbents, a critical care immunotherapy company based in Monmouth Junction, N.J., is the recipient of a $150,000 phase I Small Business Technology Transfer contract to develop a blood purification technology that may create universal plasma.  By Mackenzie Bean -

Anthem expands member access to HIV/AIDS medications

Anthem has made it easier for health plan members to receive HIV/AIDS specialty medications, no longer requiring members to obtain the drugs through a mail order program.  By Mackenzie Bean -

FDA seeks clinician input on how to improve drug trials

To get a more accurate read of the effectiveness of any treatment being tested in an FDA-approved clinical trial, the agency is seeking comment from clinicians on how to keep researchers honest about the populations that make up study cohorts.  By Max Green -

VA teams with Underwriters Laboratories to address medical device cybersecurity

The U.S. Department of Veteran Affairs will partner with Underwriters Laboratories, a global safety science organization based in Northbrook, Ill., to improve cybersecurity for medical devices through a Cooperative Research and Development Agreement.  By Mackenzie Bean -

FDA approves new catheterization device

The Food and Drug Administration approved VentureMed Group's new surgical device to treat peripheral artery disease.  By Mackenzie Bean -

One-third of cancer patients suffer financial hardship due to drug costs: 4 things to know

Patient Power, a global provider of educational audio and video content for people with cancer, surveyed more than 1,000 cancer patients and found that 1/3 of them undergo financial strain as a result of high drug costs.  By Mackenzie Bean -

Meet the Texas Medical Center accelerator program's class of 2016

The Texas Medical Center accelerator program facilitates the development of digital health and medical device companies at the world's largest medical center located in Houston.  By Mackenzie Bean -

NIH rejects petition to lower price of taxpayer-funded cancer drug

The federal government turned down a petition to lower the price of a $129,000 drug used to treat advanced prostate cancer, according to ABC News.  By Mackenzie Bean -

FDA issues final guidance on data analysis for pediatric medical devices

The Food and Drug Administration issued a final guidance on Monday for how and when existing clinical data should be used to support pediatric medical device indications and labeling.  By Mackenzie Bean -

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