Better Therapeutics Inc. has commenced a real-world evidence study with Steward Health Care to assess the long-term impact of its BT-001 digital therapeutic in the treatment of type 2 diabetes. The investigational prescription solution delivers cognitive behavioral therapy to patients with uncontrolled type 2 diabetes. Read More
PARIS – Roche SAS, the French division of Swiss pharmaceuticals manufacturer Roche Holding AG, has signed a partnership with Unicancer that brings together all the cancer centers in France. They have created Oncodatahub (ODH), the first real-world cancer data platform in France. This makes a set of quality, longitudinal data representative of cancer patient care in France available to all those involved in the health care ecosystem. Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) has decided to leave the onus on Medicare administrative contractors (MACs) to make coverage determinations regarding the Allomap test for heart transplant rejection despite a request for a non-coverage policy. As was the case in the decision to allow MACs to determine coverage for total artificial hearts, the CMS said that the low annual rate of utilization of the Allomap, by Caredx Inc., of Brisbane, Calif., suggested that the MACs are in a better position to make the appropriate call regarding coverage. Read More
The FDA granted an investigational device exemption (IDE) to Hancock Jaffe Laboratories Inc. for Venovalve, clearing the way for the company to begin a pivotal trial of the implantable valve in patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The company’s first patent covering the device was issued by the U.S. Patent and Trademark Office on April 7. Read More
HONG KONG – A professor at the Chinese University of Hong Kong (CUHK) claims that retinal eye scanning can help to improve early detection of autism and treatment outcomes for children. Benny Zee, a professor at CUHK, has developed a method to identify children at risk of autism and get them into treatment programs sooner. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acerta Pharma, Castle Biosciences, Linus Health, Veracyte. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Oncosec Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS may reverse non-coverage for catheter pulmonary embolectomy. Read More
Keeping you up to date on recent developments in orthopedics, including: X-rays confirm promise of new luminescent markers; Pillar of support: Breakthrough discovery could speed up bone implant recovery; New biosealant can stabilize cartilage, promote healing after injury. Read More
