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FDA Approves First-Ever Mobile App for Addiction Treatment

The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD)....more

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the...more

Obamacare Replacement Would Repeal Medical Device Tax

Republican lawmakers recently proposed a replacement of Obamacare known as the American Health Care Act (AHCA). One provision of the proposed legislation would permanently repeal Obamacare’s 2.3% medical device excise tax. ...more

First FDA Approval of Closed-Loop Insulin Pump

Medtronic’s MiniMed 670G system was recently approved by the FDA – this marks the first-ever FDA approval of a hybrid closed-loop insulin delivery system. Medtronic explains that the system uses a computer algorithm in...more

10/19/2016  /  FDA Approval , Medical Devices , Medtronic

First-Ever FDA Approval of Liquid Biopsy for Detecting Lung Cancer

The New York Times reports that Roche, a Swiss biotech company, recently received the first-ever FDA approval for a “liquid biopsy” test for diagnosing non-small cell lung cancer (NSCLC).  The Times reports that while the...more

Stryker’s Next Acquisition – Physio-Control

Medical device maker Stryker Corp. recently announced that it will buy Physio-Control, a manufacturer of emergency defibrillators and other emergency medical response products based in Redmond, Washington. According to...more

3/23/2016  /  Acquisitions , Medical Devices , Stryker

NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage

Spinal device specialist NuVasive recently received section 501(k) FDA clearance for its X-Core Mini Cervical Expandable VBR System, a titanium vertebral-body replacement device used in the cervical spine to replace vertebral...more

10/27/2015  /  510(k) RTA , FDA , Medical Devices , Patents
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