While launching a new balloon-based device to treat chronic sinusitis, Entellus Medical Inc. revealed it would release details on an important clinical study in July.
Noted physician/entrepreneur John Simpson is back. His latest company, Avinger, has finally achieved his long-sought goal: combining imaging and therapeutics in catheter technology for crossing CTOs. Will clinical innovation be enough to reward Avinger in an increasingly economically focused medtech world?
Corporate VCs are increasingly becoming a stable supplier of capital to medical device companies. Corporate investors have been participating in a growing percentage of deals being done, according to Elsevier’s Strategic Transactions, and remain focused on later-stage rounds.
On the last day of hearings by three House Energy and Commerce subcommittees March 19-21, CDRH Office of Device Evaluation Director Christy Foreman largely reiterated FDA’s previously stated approach to regulating mobile medical apps. Meanwhile, Energy and Commerce Committee Vice Chair Marsha Blackburn, R-Tenn., hinted at legislation on the issue.
Belgium-based Endo Tools Therapeutics SA is developing devices that will enable NOTES procedures to treat disorders such as type 2 diabetes, morbid obesity, and digestive tract tumors. Its Endomina device is a universal, multi-channel triangulation platform for use on any existing endoscope through the natural orifices, such as the esophagus.
Pancreatic cancer is currently the fourth leading cause of cancer death in the US, and it is primarily treated with systemic drugs that have limited ability to penetrate the pancreas. RenovoRx Inc. has developed an endovascular catheter that enables targeted delivery of either diagnostic or therapeutic fluids directly to the pancreas.
CMS held its annual new-technology Town Hall February 5, hearing from applicants for a drug-eluting peripheral artery stent, a neurostimulator system for epilepsy seizures, a transcatheter mitral valve repair system and a retinal prosthesis system.
Recent visits to Brazil by three medical device trade groups are telling of the opportunities there for U.S. device companies, in spite of barriers related to regulation, reimbursement and compliance.
Ethicon hopes to increase penetration in the advanced energy market with its new ENSEAL G2 Articulating Tissue Sealer, a first-of-its-kind, articulating, laparoscopic energy device designed for use in complex procedures, including colorectal, thoracic, single-site, and cancer surgeries.
Traditional ablation for treating atrial fibrillation involves disconnecting the electrical pathway that causes the abnormal rhythm, and the procedure can take anywhere from two to four hours, thus limiting the number of cases a cath lab can handle each day. The self-expanding pulmonary vein implant in development at Flux Medical NV is easy to insert inside the vein and should make the procedure much shorter, allowing a cath lab to schedule up to six to eight cases a day.
