Center for Devices and Radiological Health Archives

How alcohol could make renal denervation for hypertension faster and simpler

Ablative Solutions President and CEO Kate Rumrill [Photo courtesy of Ablative Solutions]

Ablative Solutions is developing the Peregrine renal denervation (RDN) system to treat hypertension. The company hopes to follow Recor Medical and Medtronic in winning FDA approval for the system.

“As a small company, it’s definitely better to be a fast follower than it is to be first to market,” Ablative Solutions CEO Kate Rumrill said in an interview. “I’m excited for Medtronic and Recor and their first year of sales and having these larger companies out there, doing some of that early work as far as market awareness and market adoption.”

Medtronic’s Symplicity Spyral RDN system uses radiofrequency (RF) energy, while Recor’s Paradise system uses ultrasound. Peregrine doesn’t deliver energy at all, instead using alcohol as a neurolytic agent.

“There …

FDA and VA Ventures Innovation Institute partner on new medical device testing tools

Dr. Beth Ripley is the medical device testing collaboration’s project manager for the VA. [Photo courtesy of the Department of Veterans Affairs]

The Department of Veterans Affairs’ VA Ventures Innovation Institute in Seattle will host up to a dozen FDA staffers in a new collaboration to develop and share new tools for medical device testing safety and efficacy.

The agencies intend to provide developers of devices and new technology with off-the-shelf tools that can help streamline regulatory review and get products to patients faster. FDA staff from the Center for Devices and Radiological Health (CDRH) will focus on regulatory science. Their partners at the VA’s Veterans Health Administration (VHA) will provide clinical context for test development and provide hands-on training and other immersive experiences for innovators wishing to utilize the tools.

RELATED: FDA issues draft guidanc…

FDA releases MDUFA V details after industry negotiations

The FDA today released details of its agreement with the medtech industry for reauthorization of the Medical Device User Fee Amendments (MDUFA).

If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier this month after regulators and industry representatives negotiated updates to the program, which collects fees from applicants to fund FDA review.

The FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research will work with companies submitting products for faster, more efficient reviews and decisions without sacrificing product safety or effectiveness, the FDA said in the 38-page MUFDA V commitment letter. For example, the agreement sets the goal of making 510(k) clearance decisions within 128 calendar days for applications received in fiscal year 2023 and reducing that time to 112 days within two years.

…

FDA releases MDUFA V details after industry negotiations

The FDA today released details of its agreement with the medtech industry for reauthorization of the Medical Device User Fee Amendments (MDUFA).

If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier this month after regulators and industry representatives negotiated updates to the program, which collects fees from applicants to fund FDA review.

The FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research will work with companies submitting products for faster, more efficient reviews and decisions without sacrificing product safety or effectiveness, the FDA said in the 38-page MUFDA V commitment letter. For example, the agreement sets the goal of making 510(k) clearance decisions within 128 calendar days for applications received in fiscal year 2023 and reducing that time to 112 days within two years…

MDO analysis: FDA medical device recalls drop to lowest levels since 2013

FDA medical device product recalls dropped last year to the lowest number since 2013, according to a Medical Design & Outsourcing analysis of newly released recall data from the regulatory agency.

Device products recalled in fiscal year 2021 (ended Sept. 30) totaled 2,607, a 14.3% drop from the 3,042 recalls reported in fiscal 2020.

The drop in device recalls occurred at the same time the FDA put more emphasis on fighting the COVID-19 pandemic and improving device safety protocols, according to FDA’s Center for Devices and Radiological Health (CDRH) annual report. CDRH Director Dr. Jeff Shuren said in September that the agency was “starting to turn the corner” on catching up on submissions, after having focused on the pandemic and issuing emergency use authorizations (EUA) in record times. But that was also before the virus’s omicron variant hit.

The 2,607 figure from last year is the fewest product recalls dating back to fisc…