510K Archives - Serious Startups

The ZeroTo510 startup accelerator in Memphis Tennessee is the first cohort-based medical device startup accelerator in the country. The joint venture between Start Co and Memphis Bioworks puts medical device companies through an accelerator program and helps shape scientists and engineers into startup founders.

The other, important goal for ZeroTo510 is getting these medical device startups to the 510(k) approval from the FDA. This approval is a quicker path to market roughly based on the idea that your product is expanding on an idea or improving an idea previously approved by the FDA. In short a typical FDA approval for a new device can take anywhere from 3-10 years while a 510 (k) approval can shorten that time down to 1-3 years.

All of the companies selected for the first two completed cohorts at ZeroTo510 (summer 2012 and summer 2013) werelooking to get that approval and get their product to market.

We’ve covered Restore Medical almost from the point when founders Shawn Flynn and Ryan Ramkhelawan made the move from Atlanta to Memphis for the accelerator at the beginning of summer 2012. At that time both founders told Nibletz that they liked Bioworks and the cohesiveness of the Memphis startup community, despite the fact that Atlanta is a much larger city.

Restore Medical has developed a system that more thoroughly, cleanly, cheaply and greenly sterilizes surgical instruments. The way surgical instruments are currently sterilized is time consuming. Not only that, but if one instrument is found to be unsterile the entire batch of instruments for a particular surgery needs to go through the process again. This can take hours at a time, so the OR teams must make a decision on whether to wake up the patient or to keep the patient under anesthesia which can be costly for the doctors and the patients not to mention dangerous.

“Our product allows hospitals to clean and re-sterilize surgical instruments more efficiently, saving time and money,” Flynn, the company President said in a statement. “More importantly, it improves the sterilization process, reducing the chances that a patient will be infected by contaminated instruments.

Restore Medical Solutions announced on Thursday that they had received their FDA 510(k) clearance. The company is also pleased to announced that it has successfully completed the certification process for internationally recognized medical device specific quality management standards ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System (CMDCAS). Certification was conducted by BSI Group, one of the world′s leading certification bodies.

“These clearances allow us to market our products domestically and internationally, and they show that our product is safe, effective and meets regulatory requirements in both the United States and Canada,” said Ramkhelawan.

Restore Medical Solutions is moving into a larger 2500 square foot space in the Memphis Bioworks complex which will allow them space for assembly and distribution.

You can find out more about Restore Medical Solutions here.

TECH Fort Worth Startup Ampcare Gets FDA 510K Approval For Technology To Improve Swallowing

Russ Campbell, President & CEO of Fort Worth startup Ampcare

Last month we brought you a story about Memphis startup Handminder and what they are doing for stroke victims. Handminder has a technology that re-teaches the brain to interact with the hands of stroke victims so they can relearn motor skills. Handminder was part of Memphis’ Zeroto510 accelerator that prepares medical device companies for their 510K FDA approval.

Last week it was announced that TECH ForthWorth startup Ampcare just received their 510K approval from the FDA for their technology that also helps stroke victims.

Ampcare’s Rx3E series of electrodes applies external stimulation to the muscles needed for swallowing. This is also a technology that directly impacts the lives of stroke victims, and those suffering from Alzheimer’s, Parkinson’s, ALD (Lou Gehrig’s Disease) and Muscular Dystrophy.

Russ Campbell, Rick McAdoo and Ronda Polansky, the three therapists that founded Ampcare, envisioned the device as a treatment option to treat swallowing problems.

“At Ampcare, we understand that eating and drinking affect quality of life. This product will offer healthcare professionals, specifically speech language pathologists, a technologically advanced treatment approach to address swallowing difficulties,” said Russ Campbell, President & CEO.

Dysphagia, or difficulty with swallowing, affects 18 million people in the U.S. Without proper management, dysphagia can lead to choking, malnutrition, dehydration, weight loss, muscle attrition, aspiration pneumonia, increased rate of infection and death.

“For example, people with strokes often lose their ability to protect their airway when eating and drinking,” McAdoo said. “Our device rehabilitates the muscles that move the airway to keep it protected during swallowing.”

Ampcare’s technology is just as important for comfort as it is for patient safety.

Ampcare is a startup resident at the TECH Fort Worth Incubator in Texas.

“Since May, when Ampcare won our Impact Award, the team has been pressing hard for this next milestone, the clearance of its product for the market,” said Darlene Ryan, Executive Director of TECH Fort Worth. “The Ampcare founders have their heart in this product. Their motivation is the patients who will have a higher quality of life because of their work. It is clients like this that inspire me to do everything I can to help them and others continue to bring new products to market that really matter.”

Linkage:

Check out Ampcare here

TECH Fort Worth here

Everywhereelse Here