1. Medtech Insight
  2. >>Device Area
  3. >>Cardiology

US Approvals Analysis: Biotronik Making Its Interventional Mark

 
• By David Filmore

The German-headquartered firm is making a play to enter the US vascular intervention market, with two stents approved by FDA under original PMAs in the first quarter of 2017. Cardiovascular devices, in general, have gained the most novel-device approvals so far this year, followed by IVDs. Check out more from a Q1 look at US FDA approvals and clearances monitored by Medtech Insight's Approvals Tracker.

FDA approved background, 3D rendering, blue street sign

[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out our Approvals Tracker.]

After one quarter, Biotronik SE & Co. KG is leading in 2017 novel device approvals (original PMAs, panel-track supplements...

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
Start Free Trial

Already a subscriber?

More from Cardiology

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

 
• By Natasha Barrow

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

 
• By Brian Bossetta

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 Marion Webb

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

 
• By Natasha Barrow

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 Marion Webb

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

 
• By Brian Bossetta

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 Marion Webb

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.