What Matters: March's MedTech News You Need to Know

Overheard at GMM HQ

"Now easier to get than an Adele concert ticket." – Holley Malia, lauding progressive measures being implemented toimprove patient access to new standards of care.

WHAT THE INDUSTRY IS BUZZING ABOUT

THEY VONT TO SUCK PROTECT YOUR BLOOD

As the Zika virus continues to spread worldwide, the FDA has issued a new guidance to ensure the protection of the U.S.'s blood supply, including a four-week deferral of individuals from donating blood if they have potentially been exposed to the virus or have had a confirmed infection. Don't worry, you'll still get your cookie afterwards.

DIAGNOSTICS, VACCINES, AND MOSQUITOS — OH MY!

In addition to protecting the nation's blood supply, the FDA is also prioritizing the development of blood screening and diagnostic tests to identify the virus, evaluating the safety and efficacy of investigational vaccines and therapeutics, and reviewing mosquito-suppressing technology. More sophisticated than your typical bug zapper.

THE 411

Although there have been no reports to date of the Zika virus entering the U.S. blood supply via blood donations, the risk of blood transmission is considered likely. A garlic bulb necklace might ward off blood-sucking vampires, but it probably won't do much to protect us from Zika.  

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ALL ABOUT THE BREASTS

Mentor, a subsidiary of Johnson & Johnson, won FDA investigational device exemption (IDE) approval for clinical trial testing of its Athena MemoryGel breast implants, which address a need for larger implants than what is currently available.

SIZE MATTERS

Get your mind out of the gutter already. The trial, which will study implants larger than 800cc, is designed to address breast reconstruction for patients with larger chest widths, larger breast sizes, higher BMI or greater amounts of removed tissue.

THE 411

J & J is slated to enroll 600 primary and revisionary breast reconstruction patients at 35 sites across the U.S. in its clinical trial by April 2016. The IDE is good news for J & J, whose cup truly runneth over.

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IT Rx

California’s Hollywood Presbyterian Medical Center (HPMC) staff declared an internal emergency after hackers forced the hospital's IT systems offline. Doctors have subsequently been forced to communicate via fax because no homing pigeons were available.  

RANSOM LETTER 2.0

What did the hackers want? A ransom. But not just any ransom — they wanted 9,000 in Bitcoin (equivalent to $3.2 million) before the systems are put back online. Unmarked tens and twenties are for rookies.

THE 411

HPMC showed some serious negotiating skills and haggled the ransom down to $17,000 worth of Bitcoin. The hospital reports that patient care has not been compromised, and that only day-to-day operations have been affected. Unrelated: Xanax prescriptions predicted to skyrocket at the hospital staff pharmacy.

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GOOD TO KNOW

No wonder we're feeling so effing tired. #tripleskinnylatteplease





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