Work With Patients To Design Trials For Anti-Hypertensive Devices, FDA Advisors Suggest

FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.

FDA Advisory Committee Feature image

Experts on US FDA's Circulatory System Devices Panel say they are encouraged that device interventions currently in development will help address the hypertension "epidemic" in the US that is not currently well-managed by medication and lifestyle interventions alone.

At the panel's Dec. 5 meeting in Gaithersburg, Md., FDA gathered suggestions to help sponsors and the agency design...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Cardiology

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

Injuries And Deaths Linked To Baxter Infusion Pump

 

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

HeartFlow Takes Another Crack At Public Markets With $100M IPO Filing

 
• By 

AI heart imaging company HeartFlow filed for a $100m IPO after scrapping its 2022 SPAC plans. It remains unprofitable but is betting on FDA clearances, Medicare coverage and a demand for AI-powered diagnostics to win over investors.

Abbott Lowers Outlook But Headwinds Are Temporary

 

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

More from Device Area

ForSight Sets Its Sights On Automating Delicate Eye Procedures

 
• By 

ForSight Robotics is developing a robotic platform to automate cataract and other eye surgeries, aiming to ease surgeon strain and expand access. Backed by $200m in total funding, it's targeting a first human surgery using Oryom by year-end and is in discussions with US FDA.

Injuries And Deaths Linked To Baxter Infusion Pump

 

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Private Equity Firm Archimed To Buy ZimVie As Antitrust Concerns Sideline Strategic Buyers

 
• By 

Archimed will acquire dental implant firm ZimVie for $730m in a deal that reflects private equity’s growing role in medtech M&A, as strategic buyers face antitrust scrutiny. The deal includes a 125% premium and a 40-day window for competing offers.