Anika Therapeutics received the final FDA 510(k) clearance for its Integrity implant system for improving outcomes in rotator cuff repair procedures through biologic healing. The hyaluronic acid-based patch augments an injured tendon, promoting rotator cuff healing. Fast Five hosts Sean Whooley and Danielle Kirsh delve into how the device works and what the regulatory nod means for Anika.

Ventricular assist devices save lives and another one may soon be entering the fold. MagAssist won FDA breakthrough device designation for its NyokAssist VAD, which provides mechanical circulatory support for high-risk percutaneous interventions. Find out what led the agency to grant this designation.

Axonics will soon have a new chief financial officer after longtime executive Dan Dearen notified the company of his intent to retire. The company already picked a replacement, promoting from within to fill the role. Learn more about Axonics' selection and what the new executive brings to the company in terms of experience and know-how.

In another executive change, Tandem Diabetes Care announced that its chief commercial officer plans to resign from the role. Brian B. Hansen had been the company's CCO since 2016. Whooley and Kirsh take a look at Hansen's background and the terms of a separation agreement struck between Hansen and the automated insulin delivery technology developer.

For the third time in as many months, Abiomed issued a correction for its Impella heart pumps. The FDA Class I recall pertains to the instructions for use for the system. The hosts break down the numbers behind this recall and what kind of mitigations Abiomed is implementing to remedy the issue.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.