San Antonio Startup Leto, Winner of $100K, Builds Cooler Prosthetics

For Gary Walters, the entrepreneurial brainstorm came while mowing his lawn on a hot San Antonio day.  An Iraq war veteran, Walters lost his right leg below the knee in a bomb blast eight years ago, and he has suffered from excessive heat and sweating where his prosthesis is joined to his leg, a common problem for amputees. “It gets close to 100 degrees in there,” he says. “It’s just like having your hand under water all day. Your skin starts to break down, you get friction blisters, heat rash, open sores.”

DigniCap to Help Prevent Chemo Caused Hair Loss Cleared for FDA Trial

Hair loss is often a depressing signature of chemotherapy, particularly disturbing for women who have to undergo treatment.  One way to help prevent hair loss during chemo sessions is to cool the scalp, narrowing blood vessels around hair follicles and slowing the uptake of the poison in the area.

FDA-approved device offers non-drug option for pain

The Food and Drug Administration is sending a strong message to pharmaceutical companies.  Make potent prescription pain killers “unmeltable,” “uncrushable” and hard to abuse – or face having the product pulled from the market.  But even more significant is the push now to find ways to deal with chronic pain without using addictive drugs at all.

Apple quietly bans some medical drug guides from the App Store

Apple’s iOS App Store has drawn lots of criticism for strict policies that the company forces developers to accept when creating apps for the iPhone and iPad.  The criticism is particularly frustrating when the company appears to enforce its mandates inconsistently and capriciously.  These bans can have far-reaching consequences.  That’s definitely the case for the most recent spate of app rejections.  Identified by iMedicalApps, Apple has been rejecting medical and health apps that provide information about prescription and over-the-counter medications.  The rulings appear to target drug reference guide apps that provide both on- and off-label dosage guidelines.  In rejecting these apps, Apple has cited a section in its developer requirements that states that the company will only accept dosing instructions within an app if that app is being produced by a drug’s manufacturer.  Apps that provide dosing schedules or guidelines for medications that are not created by drug makers are subject to rejection.

New Medwatch Form Geared Toward Simple Adverse Event Reporting for Consumers

The US Food and Drug Administration (FDA) is touting the 20th anniversary of one of its most essential safety reporting tools, MedWatch, which it uses to collect adverse event reports about pharmaceuticals, medical devices and other FDA-regulated products, allowing it to monitor risks to consumers and take action when necessary.  And now FDA is announcing something else: a consumer-focused MedWatch reporting form.

FDA’s 510(k) pathway is getting stronger, Medtech attorney says

 FDA analysis: 510(k) is here to stay, says Medtech attorney;  The FDA’s 510(k) “substantial equivalence” test for medical device review is strong, safe and here to stay, according to an analysis by medtech attorney Jeffrey Shapiro.

FDA Announces Planned Withdrawal, Revision of Dozens of Guidance Documents

 Got a gripe with an older draft guidance document?  Now might be the time to air that grievance, with the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announcing that it plans to conduct a retrospective analysis of all guidance documents issued prior to 2010 with the intent of withdrawing unnecessary documents or revising any documents in need of changes.