Blog
RSS FeedPosted by Michael Wonder on 04 Aug 2021
FDA regulation and approval of medical devices: 1976-2020
3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation ...
Posted by Michael Wonder on 04 Aug 2021
FDA grants breakthrough device designation status for Hancock Jaffe's VenoValve
3 August 2021 - VenoValve is a potential treatment for approximately 2.4 million U.S. patients that suffer from severe chronic venous ...
Posted by Michael Wonder on 29 Jul 2021
Biofourmis earns FDA's first ever breakthrough device designation for a novel digital therapeutic for heart failure
29 July 2021 - BiovitalsHF approved for expedited FDA review process as a first-in-class digital therapeutic for heart failure that augments ...
Posted by Michael Wonder on 26 Jul 2021
Evren Technologies receives FDA breakthrough device designation for the Phoenix
21 July 2021 - Evren Technologies announced today that its non-invasive Phoenix earbud device received Breakthrough Device Designation from the ...
Posted by Michael Wonder on 20 Jul 2021
NeuroMetrix receives FDA breakthrough device designation for treatment of fibromyalgia with its wearable neurostimulation technology
20 July 2021 - NeuroMetrix today announced that its Quell device has received breakthrough designation from the U.S. FDA for treating ...
Posted by Michael Wonder on 19 Jul 2021
Nevro announces FDA approval of its 10 kHz high frequency spinal cord stimulation therapy for treatment of chronic pain associated with painful diabetic neuropathy
19 July 2021 - HFX for painful diabetic neuropathy now the only spinal cord stimulation system approved by FDA to treat ...
Posted by Michael Wonder on 19 Jul 2021
Endologix receives FDA breakthrough device designation for ChEVAS system
19 July 2021 - Investigational EVAS system designed for patients with complex abdominal aortic aneurysm. ...
Posted by Michael Wonder on 13 Jul 2021
Stryker announces the FDA clearance of the first biodegradable subacromial balloon spacer, filling a gap in the shoulder continuum of care
13 July 2021 - The InSpace balloon implant is a breakthrough solution for arthroscopic treatment of massive irreparable rotator cuff tears ...
Posted by Michael Wonder on 07 Jul 2021
Hyalex Orthopaedics receives FDA breakthrough device designation for novel Hyalex cartilage system
7 July 2021 - Hyalex Orthopaedics announced that the Hyalex Cartilage System has been granted breakthrough device designation from the U.S. ...
Posted by Michael Wonder on 01 Jul 2021
Neuroelectrics granted FDA breakthrough device designation for new therapeutic neuromodulation platform to treat refractory focal epilepsy
30 June 2021 - In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44% median ...
Posted by Michael Wonder on 29 Jun 2021
Neuros Medical receives FDA breakthrough device designation for its novel Altius high frequency nerve block system
29 June 2021 - Neuros Medical announced today that it has received Breakthrough Device Designation from the U.S. FDA for the ...
Posted by Michael Wonder on 22 Jun 2021
Medtronic receives FDA expanded approval for Arctic Front family of cardiac cryoablation catheters for initial use for recurrent symptomatic paroxysmal atrial fibrillation
21 June 2021 - First and only approval to indicate cryoablation as an initial rhythm control strategy. ...
Posted by Michael Wonder on 21 Jun 2021
Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire
21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices ...
Posted by Michael Wonder on 18 Jun 2021
The FDA grants a breakthrough device designation to the MIScoli, an innovative vertebral body tethering device to treat idiopathic scoliosis
18 June 2021 - Spinologics announced today that the U.S. FDA has granted the company a breakthrough device designation for its ...
Posted by Michael Wonder on 18 Jun 2021
3D bioprinting can help end organ transplant waitlists — if the FDA stops delaying
18 June 2021 - Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack of ...